163 results on '"Jaroslaw Regula"'
Search Results
2. Narrow band imaging versus lugol chromoendoscopy in screening for esophageal squamous neoplasia: a randomized trial
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Anna Chaber-Ciopinska, Dorota Kiprian, Paulina Wieszczy, Andrzej Bielasik, Marek Bugajski, Wladyslaw Januszewicz, Andrzej Jarzabski, Milena Niemiec, Andrzej Mroz, Andrzej Kawecki, Jaroslaw Regula, and Michal F. Kaminski
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Internal Medicine - Published
- 2023
3. Prevalence and risk factors of upper gastrointestinal cancers missed during endoscopy: a nationwide registry-based study
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Paulina Wieszczy, Urszula Wojciechowska, Magda Socha, Michal F. Kaminski, Jaroslaw Regula, Joanna Didkowska, Maryla H. Turkot, Klaudiusz Witczak, and Wladyslaw Januszewicz
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Male ,medicine.medical_specialty ,Esophageal Neoplasms ,Adenocarcinoma ,Endoscopy, Gastrointestinal ,Risk Factors ,Internal medicine ,Prevalence ,medicine ,Humans ,Endoscopy, Digestive System ,Registries ,Gastrointestinal Neoplasms ,Retrospective Studies ,medicine.diagnostic_test ,Esophagogastroduodenoscopy ,business.industry ,Gastroenterology ,Odds ratio ,Middle Aged ,medicine.disease ,Comorbidity ,Confidence interval ,Cancer registry ,Endoscopy ,Relative risk ,Cohort ,Female ,business - Abstract
Background A significant proportion of upper gastrointestinal cancers (UGICs) remain undetected during esophagogastroduodenoscopy (EGD). We investigated the characteristics and risk factors of UGICs missed during endoscopy. Methods In this nationwide registry-based study, we analyzed two large Polish datasets (National Health Fund and National Cancer Registry) to identify individuals who underwent EGD and were subsequently diagnosed with UGIC. Cancers diagnosed Results We included 4 105 399 patients (mean age 56.0 years [SD 17.4]; 57.5 % female) who underwent 5 877 674 EGDs in 2012–2018. Within this cohort, 33 241 UGICs were diagnosed, of which 1993 (6.0 %) were missed. Within esophageal neoplasms, adenocarcinomas were more frequently missed than squamous cell cancers (6.1 % vs. 4.2 %), with a relative risk of 1.4 (95 % confidence interval [CI] 1.1–1.8, P = 0.01). Most gastric cancers were adenocarcinomas, of which 5.7 % were classified as missed. Overall, a higher proportion of missed UGICs than prevalent cancers presented at an advanced stage (42.2 % vs. 36.2 %, P Conclusions Among UGICs, esophageal adenocarcinomas were missed most frequently. Missed cancers occur more frequently within the primary care sector and are found more often in women and individuals with multiple comorbidities.
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- 2021
4. Risk factors of colorectal cancer after screening colonoscopy
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Michal F. Kaminski, Jaroslaw Regula, and Paulina Wieszczy
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Oncology ,medicine.medical_specialty ,Colorectal cancer ,business.industry ,Internal medicine ,medicine ,Screening colonoscopy ,medicine.disease ,business - Abstract
In the era of populational screening programs for colorectal cancer, evaluation of their quality and efficacy becomes an important issue. One of the main criteria taken into account when assessing the quality of a screening program is related to the risk of colorectal cancer developing in the period between the screening colonoscopy and the control examination. The objective of this article consists in presenting the results of the doctoral research carried out by dr. Paulina Wieszcza, a beneficient of the Polpharma Scientific Foundation scholarship. The objective of the doctoral dissertation was to investigate and discuss the relationship between the definition of risk groups as well as the quality of the study and the risk of colorectal cancer developing after the screening colonoscopy. The risk of colorectal cancer developing following adenomas being removed during the screening colonoscopy procedure was assessed using data obtained from the Colorectal Cancer Screening Program and the National Cancer Registry databases. The quality of the study was assessed on the basis of literature evidence regarding the adenoma detection rates (ADR). A total of 236.089 patients were included in colorectal cancer risk analyses, with at least one adenoma being detected in a screening study in 17.7% of cases. Over the follow-up period (median of 7 years, maximum duration of 14 years), colorectal cancer was detected in 439 patients. It was demonstrated that when the high-risk group was defined as patients presenting with adenomas ≥ 20 mm in diameter or high grade dysplasia rather than patients with ≥ 3 adenomas or adenomas ≥10 mm in diameter with high grade dysplasia or villous component (current definition), the number of patients requiring intensive surveillance can be reduced by 74% without any impact on the risk in the low-risk group. The literature review revealed a total of three studies which clearly showed that the risk of colorectal cancer significantly decreased with the increase in the endoscopist’s ADR. Restricting the high-risk group to patients with adenomas ≥ 20 mm in diameter or high-grade dysplasia facilitates optimized care being delivered to patients with a significantly increased risk of colorectal cancer. Scientific evidence is available for the important role of endoscopist’s ADR as the key parameter of the quality of colonoscopic examination.
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- 2021
5. Wytyczne postępowania diagnostyczno-terapeutycznego u chorych na raka odbytnicy (C20)
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Andrzej Rutkowski, Krzysztof Bujko, Jaroslaw Regula, Piotr Potemski, Joanna Socha, Anna Hołdakowska, Andrzej Mróz, and Maciej Krzakowski
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medicine.medical_specialty ,Oncology ,business.industry ,Colorectal cancer ,Internal medicine ,medicine ,business ,medicine.disease ,Gastroenterology - Published
- 2021
6. Guidelines for the management of patients with Crohn’s disease. Recommendations of the Polish Society of Gastroenterology and the Polish National Consultant in Gastroenterology
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Piotr Eder, Ewa Małecka-Wojciesko, Maria Kłopocka, Maciej Gonciarz, Magdalena Gawron-Kiszka, Edyta Zagórowicz, Grażyna Rydzewska, Jaroslaw Regula, Piotr Radwan, Michał Łodyga, Marek Hartleb, and Agnieszka Dobrowolska
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Crohn's disease ,medicine.medical_specialty ,thiopurines ,business.industry ,education ,Gastroenterology ,Guidelines ,medicine.disease ,humanities ,Family medicine ,medicine ,biological medicines ,endoscopy ,business - Abstract
This paper is an update of the diagnostic and therapeutic recommendations of the National Consultant for Gastroenterology and the Polish Society of Gastroenterology from 2012. It contains 46 recommendations for the diagnosis and treatment, both pharmacological and surgical, of Crohn's disease in adults. The guidelines were developed by a group of experts appointed by the Polish Society of Gastroenterology and the National Consultant in the field of Gastroenterology. The methodology related to the GRADE methodology was used to assess the quality and strength of the available recommendations. The degree of expert support for the proposed statement, assessment of the quality of evidence and the strength of the recommendation was assessed on a 6-point Likert scale. Voting results, quality and strength ratings with comments are included with each statement.
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- 2021
7. Reporting endoscopy quality and adverse events: Dutch step forward
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Jaroslaw, Regula
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Humans ,Endoscopy, Gastrointestinal - Published
- 2022
8. Long-Term Colorectal Cancer Incidence and Mortality After a Single Negative Screening Colonoscopy
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Nastazja Dagny Pilonis, Urszula Wojciechowska, Maciej Rupinski, Paulina Wieszczy, Malgorzata Pisera, Michal F. Kaminski, Jaroslaw Regula, Marek Bugajski, Joanna Didkowska, and Robert Franczyk
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Male ,Pediatrics ,medicine.medical_specialty ,Time Factors ,Colorectal cancer ,Population ,Colonoscopy ,Screening colonoscopy ,01 natural sciences ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Internal Medicine ,Humans ,Mass Screening ,Medicine ,030212 general & internal medicine ,0101 mathematics ,education ,Aged ,education.field_of_study ,medicine.diagnostic_test ,business.industry ,Incidence ,Mortality rate ,Incidence (epidemiology) ,010102 general mathematics ,General Medicine ,Middle Aged ,medicine.disease ,Colorectal cancer screening ,Female ,Observational study ,Poland ,Colorectal Neoplasms ,business ,Follow-Up Studies - Abstract
Current guidelines recommend a 10-year interval between screening colonoscopies, but evidence is limited.To assess the long-term risk for colorectal cancer (CRC) and death from CRC after a high- and low-quality single negative screening colonoscopy.Observational study.Polish Colonoscopy Screening Program.Average-risk individuals aged 50 to 66 years who had a single negative colonoscopy (no neoplastic findings).Standardized incidence ratios (SIRs) and standardized mortality ratios (SMRs) of CRC after high- and low-quality single negative screening colonoscopy. High-quality colonoscopy included a complete examination, with adequate bowel preparation, performed by endoscopists with an adenoma detection rate of 20% or greater.Among 165 887 individuals followed for up to 17.4 years, CRC incidence (0.28 [95% CI, 0.25 to 0.30]) and mortality (0.19 [CI, 0.16 to 0.21]) were 72% and 81% lower, respectively, than in the general population. High-quality examination resulted in 2-fold lower CRC incidence (SIR, 0.16 [CI, 0.13 to 0.20]) and mortality (SMR, 0.10 [CI, 0.06 to 0.14]) than low-quality examination (SIR, 0.32 [CI, 0.29 to 0.35]; SMR, 0.22 [CI, 0.18 to 0.25]). In multivariable analysis, the hazard ratios for CRC incidence after high-quality versus low-quality colonoscopy were 0.55 (CI, 0.35 to 0.86) for 0 to 5 years, 0.54 (CI, 0.38 to 0.77) for 5.1 to 10 years, and 0.46 (CI, 0.25 to 0.86) for 10 to 17.4 years. Only after high-quality colonoscopy did the SIR and SMR for 10.1 to 17.4 years of follow-up not differ compared with earlier observation periods.The general population was used as the comparison group.A single negative screening colonoscopy was associated with reduced CRC incidence and mortality for up to 17.4 years. Only high-quality colonoscopy yielded profound and stable reductions in CRC incidence and mortality throughout the entire follow-up.Polish Ministry of Health.
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- 2020
9. Argon plasma coagulation for Barrett’s esophagus with low-grade dysplasia: a randomized trial with long-term follow-up on the impact of power setting and proton pump inhibitor dose
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Ewa Wronska, Paulina Wieszczy, Janina Orlowska, Jaroslaw Regula, Andrzej Mroz, and Marcin Polkowski
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medicine.medical_specialty ,medicine.drug_class ,business.industry ,medicine.medical_treatment ,Gastroenterology ,Urology ,Proton-pump inhibitor ,Argon plasma coagulation ,medicine.disease ,Ablation ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,medicine.anatomical_structure ,Randomized controlled trial ,Dysplasia ,law ,030220 oncology & carcinogenesis ,Barrett's esophagus ,medicine ,030211 gastroenterology & hepatology ,Esophagus ,business ,Omeprazole ,medicine.drug - Abstract
Background This study evaluated the impact of power setting and proton pump inhibitor (PPI) dose on efficacy and safety of argon plasma coagulation (APC) of Barrett’s esophagus (BE) with low-grade dysplasia (LGD). Methods 71 patients were randomized to APC with power set at 90 W or 60 W followed by 120 mg or 40 mg omeprazole. The primary outcome was the rate of complete (endoscopic and histologic) ablation of BE at 6 weeks. Secondary outcomes included safety and long-term efficacy. Results Complete ablation rate in the 90 W/120 mg, 90 W/40 mg, and 60 W/120 mg groups was 78 % (18/23; 95 % confidence interval [CI] 61–95), 60 % (15/25; 95 %CI 41–79), 74 % (17/23; 95 %CI 56–92), respectively, at 6 weeks and 70 % (16/23; 95 %CI 51–88), 52 % (13/25; 95 %CI 32–72), and 65 % (15/23; 95 %CI 46–85) at 2 years post-treatment (differences not significant). Additional APC was required in 28 patients (23 residual and 5 recurrent BE). At median follow-up of 108 months, 66/71 patients (93 %; 95 %CI 87–99) maintained complete ablation. No high-grade dysplasia or adenocarcinoma developed. Overall, adverse events (97 % mild) did not differ significantly between groups. Chest pain/discomfort was more frequent in patients receiving 90 W vs. 60 W power (P Conclusions APC power setting and PPI dose did not impact efficacy and safety of BE ablation. Complete ablation of BE with LGD was durable in > 90 % of patients, without any evidence of neoplasia progression in the long term.
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- 2020
10. How to ensure safety during the procedures gastrointestinal diagnostics and how to treat gastrointestinal patients during the COVID-19 pandemic?
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Jaroslaw Regula and Karolina Jasionek
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medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Pandemic ,medicine ,General Medicine ,Intensive care medicine ,business - Published
- 2020
11. RAPORT: IV SPOTKANIE RADY EKSPERTÓW DS. ONKOLOGII MEDYCZNEJ RACJI STANU. IV MEETING OF THE COUNCIL OF ONCOLOGY EXPERTS OF MEDICAL REASON OF STATE
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Gierczyński, Jakub, Błażewicz, Grzegorz, Małgorzata Bogusz, Chudecka-Głaz, Anita, Czupryniak, Leszek, Władysław Duda, Giannopoulos, Krzysztof, Gil, Lidia, Karaszewski, Maciej, Paweł Kowal, Krzakowski, Maciej, Lech-Maranda, Ewa, Maciejczyk, Adam, Małecka-Libera, Beata, Mierzejewski, Piotr, Parkitna, Joanna, Pienkowski, Tadeusz, Radziwon, Piotr, Jaroslaw Regula, Rutkowski, Piotr, and Schymalla, Iwona
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- 2022
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12. Endoscopy
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Walter Elisei and Jaroslaw Regula
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- 2022
13. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial
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Laurent Peyrin-Biroulet, Ailsa Hart, Peter Bossuyt, Millie Long, Matthieu Allez, Pascal Juillerat, Alessandro Armuzzi, Edward V Loftus, Elham Ostad-Saffari, Astrid Scalori, Young S Oh, Swati Tole, Akiko Chai, Jennifer Pulley, Stuart Lacey, William J Sandborn, Humberto Aguilar, Tariq Ahmad, Evangelos Akriviadis, Xavier Aldeguer Mante, Istvan Altorjay, Ashwin Ananthakrishnan, Vibeke Andersen, Montserrat Andreu Garcia, Guy Aumais, Irit Avni-Biron, Jeffrey Axler, Kamran Ayub, Filip Baert, Mauro Bafutto, George Bamias, Isaac Bassan, Curtis Baum, Laurent Beaugerie, Brian Behm, Pradeep Bekal, Michael Bennett, Fernando Bermejo San Jose, Charles Bernstein, Dominik Bettenworth, Sudhir Bhaskar, Livia Biancone, Bahri Bilir, Michael Blaeker, Stuart Bloom, Verle Bohman, Francisco Javier Bosques Padilla, Yoram Bouhnik, Gerd Bouma, Raymond Bourdages, Stephan Brand, Brian Bressler, Markus Brückner, Carsten Buening, Franck Carbonnel, Thomas Caves, Jonathon Chapman, Jae Hee Cheon, Naoki Chiba, Camelia Chioncel, Dimitrios Christodoulou, Martin Clodi, Albert Cohen, Gino Roberto Corazza, Richard Corlin, Rocco Cosintino, Fraser Cummings, Robin Dalal, Silvio Danese, Marc De Maeyer, Carlos Fernando De Magalhães Francesconi, Aminda De Silva, Henry Debinski, Pierre Desreumaux, Olivier Dewit, Geert D'Haens, Sandra Di Felice Boratto, John Nik Ding, Tyler Dixon, Gerald Dryden, George Aaron Du Vall, Matthias Ebert, Ana Echarri Piudo, Robert Ehehalt, Magdy Elkhashab, Craig Ennis, Jason Etzel, Jan Fallingborg, Brian Feagan, Roland Fejes, Daniel Ferraz de Campos Mazo, Valéria Ferreira de Almeida Borges, Andreas Fischer, Alan Fixelle, Mark Fleisher, Sharyle Fowler, Bradley Freilich, Keith Friedenberg, Walter Fries, Csaba Fulop, Mathurin Fumery, Sergio Fuster, Gyula G Kiss, Santiago Garcia Lopez, Sonja Gassner, Kanwar Gill, Cyrielle Gilletta de Saint Joseph, Philip Ginsburg, Paolo Gionchetti, Eran Goldin, Adrian-Eugen Goldis, Hector Alejandro Gomez Jaramillo, Maciej Gonciarz, Glenn Gordon, Daniel Green, Jean-Charles Grimaud, Rogelio Guajardo Rodriguez, Zoltan Gurzo, Alexandra Gutierrez, Tibor Gyökeres, Ki Baik Hahm, Stephen Hanauer, John Hanson, William Harlan III, Peter Hasselblatt, Buhussain Hayee, Xavier Hebuterne, Peter Hendy, Melvin Heyman, Peter Higgins, Raouf Hilal, Pieter Hindryckx, Frank Hoentjen, Peter Hoffmann, Frank Holtkamp-Endemann, Gerald Holtmann, Gyula Horvat, Stefanie Howaldt, Samuel Huber, Ikechukwu Ibegbu, Maria Isabel Iborra Colomino, Peter Irving, Kim Isaacs, Kiran Jagarlamudi, Rajesh Jain, Sender Jankiel Miszputen, Jeroen Jansen, Jennifer Jones, John Karagiannis, Nicholas Karyotakis, Arthur Kaser, Lior Katz, Seymour Katz, Leo Katz, Nirmal Kaur, Edita Kazenaite, Reena Khanna, Sunil Khurana, Joo Sung Kim, Young-Ho Kim, Sung Kook Kim, Dongwoo Kim, Jochen Klaus, Dariusz Kleczkowski, Pavel Kohout, Bartosz Korczowski, Georgios Kouklakis, Ioannis Koutroubakis, Richard Krause, Tunde Kristof, Ian Kronborg, Annette Krummenerl, Limas Kupcinskas, Jorge Laborda Molteni, David Laharie, Adi Lahat-zok, Jonghun Lee, Kang-Moon Lee, Rupert Leong, Henry Levine, Jimmy Limdi, James Lindsay, Nilesh Lodhia, Edward Loftus, Randy Longman, Pilar Lopez Serrano, Edouard Louis, Maria Helena Louzada Pereira, John Lowe, Stefan Lueth, Milan Lukas, Giovanni Maconi, Finlay Macrae, Laszlo Madi-Szabo, Uma Mahadevan-Velayos, Everson Fernando Malluta, Fazia Mana, Peter Mannon, Gerasimos Mantzaris, Ignacio Marin Jimenez, Maria Dolores Martin Arranz, Radu-Bogdan Mateescu, Felipe Mazzoleni, Agnieszka Meder, Ehud Melzer, Jessica Mertens, Konstantinos Mimidis, Brent Mitchell, Tamas Molnar, Gregory Moore, Luis Alonso Morales Garza, Reme Mountifield, Vinciane Muls, Charles Murray, Bela Nagy, Markus Neurath, Augustin Nguyen, Remo Panaccione, William Pandak, Julian Panes Diaz, Jihye Park, Luca Pastorelli, Bhaktasharan Patel, Markus Peck-Radosavljevic, Gyula Pecsi, Farhad Peerani, Javier Perez Gisbert, Martin Pesta, Robert Petryka, Raymond Phillips, Marieke Pierik, Vijayalakshmi Pratha, Vlastimil Prochazka, Istvan Racz, Graham Radford-Smith, Daniel Ramos Castañeda, Odery Ramos Júnior, Jaroslaw Regula, Jean-Marie Reimund, Bryan Robbins, Xavier Roblin, Francesca Rogai, Gerhard Rogler, Jerzy Rozciecha, David Rubin, Azalia Yuriria Ruiz Flores, Maciej Rupinski, Grazyna Rydzewska, Sumona Saha, Simone Saibeni, Agnes Salamon, Zoltan Sallo, Bruce Salzberg, Douglas Samuel, Sunil Samuel, William Sandborn, Edoardo Vincenzo Savarino, Anja Schirbel, Robert Schnabel, Stefan Schreiber, John Scott, Shahriar Sedghi, Frank Seibold, Jakob Seidelin, Ursula Seidler, Ahmad Shaban, Ira Shafran, Aasim Sheikh, Alex Sherman, Haim Shirin, Patryk Smolinski, Geun Am Song, Konstantinos Soufleris, Alexander Speight, Dirk Staessen, Andreas Stallmach, Michael Staun, Daniel Stein, Hillary Steinhart, Jonathas Stifft, David Stokesberry, Andreas Sturm, Keith Sultan, Gyorgy Szekely, Kuldeep Tagore, Hugo Tanno, Lena Thin, Syed Thiwan, Carlton Thomas, Michal Tichy, Gabor Tamas Toth, Zsolt Tulassay, Jan Ulbrych, John Valentine, Marta Varga, Eduardo Vasconcellos, Byron Vaughn, Brenda Velasco, Francisco Velazquez, Severine Vermeire, Erica Villa, Aron Vincze, Harald Vogelsang, Miroslava Volfova, Lucine Vuitton, Petr Vyhnalek, Peter Wahab, Jens Walldorf, Mattitiahu Waterman, John Weber, L. Michael Weiss, Anna Wiechowska-Kozlowska, Elise Wiesner, Thomas Witthoeft, Robert Wohlman, Barbara Wozniak-Stolarska, Bruce Yacyshyn, Byong-Duk Ye, Ziad Younes, Lígia Yukie Sassaki, Cyrla Zaltman, Stefan Zeuzem, Neurosurgery, ANS - Neurovascular Disorders, Gastroenterology and Hepatology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Peyrin-Biroulet L., Hart A., Bossuyt P., Long M., Allez M., Juillerat P., Armuzzi A., Loftus E.V., Ostad-Saffari E., Scalori A., Oh Y.S., Tole S., Chai A., Pulley J., Lacey S., Sandborn W.J., Aguilar H., Ahmad T., Akriviadis E., Aldeguer Mante X., Altorjay I., Ananthakrishnan A., Andersen V., Andreu Garcia M., Aumais G., Avni-Biron I., Axler J., Ayub K., Baert F., Bafutto M., Bamias G., Bassan I., Baum C., Beaugerie L., Behm B., Bekal P., Bennett M., Bermejo San Jose F., Bernstein C., Bettenworth D., Bhaskar S., Biancone L., Bilir B., Blaeker M., Bloom S., Bohman V., Bosques Padilla F.J., Bouhnik Y., Bouma G., Bourdages R., Brand S., Bressler B., Bruckner M., Buening C., Carbonnel F., Caves T., Chapman J., Cheon J.H., Chiba N., Chioncel C., Christodoulou D., Clodi M., Cohen A., Corazza G.R., Corlin R., Cosintino R., Cummings F., Dalal R., Danese S., De Maeyer M., De Magalhaes Francesconi C.F., De Silva A., Debinski H., Desreumaux P., Dewit O., D'Haens G., Di Felice Boratto S., Ding J.N., Dixon T., Dryden G., Du Vall G.A., Ebert M., Echarri Piudo A., Ehehalt R., Elkhashab M., Ennis C., Etzel J., Fallingborg J., Feagan B., Fejes R., Ferraz de Campos Mazo D., Ferreira de Almeida Borges V., Fischer A., Fixelle A., Fleisher M., Fowler S., Freilich B., Friedenberg K., Fries W., Fulop C., Fumery M., Fuster S., G Kiss G., Garcia Lopez S., Gassner S., Gill K., Gilletta de Saint Joseph C., Ginsburg P., Gionchetti P., Goldin E., Goldis A.-E., Gomez Jaramillo H.A., Gonciarz M., Gordon G., Green D., Grimaud J.-C., Guajardo Rodriguez R., Gurzo Z., Gutierrez A., Gyokeres T., Hahm K.B., Hanauer S., Hanson J., Harlan III W., Hasselblatt P., Hayee B., Hebuterne X., Hendy P., Heyman M., Higgins P., Hilal R., Hindryckx P., Hoentjen F., Hoffmann P., Holtkamp-Endemann F., Holtmann G., Horvat G., Howaldt S., Huber S., Ibegbu I., Iborra Colomino M.I., Irving P., Isaacs K., Jagarlamudi K., Jain R., Jankiel Miszputen S., Jansen J., Jones J., Karagiannis J., Karyotakis N., Kaser A., Katz L., Katz S., Kaur N., Kazenaite E., Khanna R., Khurana S., Kim J.S., Kim Y.-H., Kim S.K., Kim D., Klaus J., Kleczkowski D., Kohout P., Korczowski B., Kouklakis G., Koutroubakis I., Krause R., Kristof T., Kronborg I., Krummenerl A., Kupcinskas L., Laborda Molteni J., Laharie D., Lahat-zok A., Lee J., Lee K.-M., Leong R., Levine H., Limdi J., Lindsay J., Lodhia N., Loftus E., Longman R., Lopez Serrano P., Louis E., Louzada Pereira M.H., Lowe J., Lueth S., Lukas M., Maconi G., Macrae F., Madi-Szabo L., Mahadevan-Velayos U., Malluta E.F., Mana F., Mannon P., Mantzaris G., Marin Jimenez I., Martin Arranz M.D., Mateescu R.-B., Mazzoleni F., Meder A., Melzer E., Mertens J., Mimidis K., Mitchell B., Molnar T., Moore G., Morales Garza L.A., Mountifield R., Muls V., Murray C., Nagy B., Neurath M., Nguyen A., Panaccione R., Pandak W., Panes Diaz J., Park J., Pastorelli L., Patel B., Peck-Radosavljevic M., Pecsi G., Peerani F., Perez Gisbert J., Pesta M., Petryka R., Phillips R., Pierik M., Pratha V., Prochazka V., Racz I., Radford-Smith G., Ramos Castaneda D., Ramos Junior O., Regula J., Reimund J.-M., Robbins B., Roblin X., Rogai F., Rogler G., Rozciecha J., Rubin D., Ruiz Flores A.Y., Rupinski M., Rydzewska G., Saha S., Saibeni S., Salamon A., Sallo Z., Salzberg B., Samuel D., Samuel S., Sandborn W., Savarino E.V., Schirbel A., Schnabel R., Schreiber S., Scott J., Sedghi S., Seibold F., Seidelin J., Seidler U., Shaban A., Shafran I., Sheikh A., Sherman A., Shirin H., Smolinski P., Song G.A., Soufleris K., Speight A., Staessen D., Stallmach A., Staun M., Stein D., Steinhart H., Stifft J., Stokesberry D., Sturm A., Sultan K., Szekely G., Tagore K., Tanno H., Thin L., Thiwan S., Thomas C., Tichy M., Toth G.T., Tulassay Z., Ulbrych J., Valentine J., Varga M., Vasconcellos E., Vaughn B., Velasco B., Velazquez F., Vermeire S., Villa E., Vincze A., Vogelsang H., Volfova M., Vuitton L., Vyhnalek P., Wahab P., Walldorf J., Waterman M., Weber J., Weiss L.M., Wiechowska-Kozlowska A., Wiesner E., Witthoeft T., Wohlman R., Wozniak-Stolarska B., Yacyshyn B., Ye B.-D., Younes Z., Yukie Sassaki L., Zaltman C., and Zeuzem S.
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Adult ,Male ,Ulcerative Colitis Flare ,medicine.medical_specialty ,Asia ,Adolescent ,Oceania ,Population ,Antibodies, Monoclonal, Humanized ,Injections, Subcutaneou ,Placebo ,Severity of Illness Index ,law.invention ,Middle East ,Young Adult ,Maintenance therapy ,Randomized controlled trial ,law ,Internal medicine ,Gastrointestinal Agent ,medicine ,Adverse effect ,education ,Aged ,Aged, 80 and over ,Tumor Necrosis Factor Inhibitor ,education.field_of_study ,Hepatology ,business.industry ,Remission Induction ,Gastroenterology ,Middle Aged ,South America ,medicine.disease ,Ulcerative colitis ,Europe ,Treatment Outcome ,Etrolizumab ,North America ,Colitis, Ulcerative ,Female ,business ,Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5] ,Human - Abstract
Summary Background Etrolizumab is a gut-targeted, anti-β7 integrin, monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission compared with placebo in patients with moderately to severely active ulcerative colitis. We aimed to evaluate the efficacy and safety of etrolizumab in patients with moderately to severely active ulcerative colitis who had been previously treated with anti-tumour necrosis factor (TNF) agents. Methods HICKORY was a multicentre, phase 3, double-blind, placebo-controlled study in adult (18–80 years) patients with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6–12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) previously treated with TNF inhibitors. Patients were recruited from 184 treatment centres across 24 countries in North America, South America, Europe, Asia, Oceania, and the Middle East. Patients needed to have an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. In cohort 1, patients received open-label etrolizumab 105 mg every 4 weeks for a 14-week induction period. In cohort 2, patients were randomly assigned (4:1) to receive subcutaneous etrolizumab 105 mg or placebo every 4 weeks for the 14-week induction phase. Patients in either cohort achieving clinical response to etrolizumab induction were eligible for the maintenance phase, in which they were randomly assigned (1:1) to receive subcutaneous etrolizumab 105 mg or placebo every 4 weeks through to week 66. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants (induction randomisation only), baseline disease activity, week 14 MCS remission status (maintenance randomisation only), and induction cohort (maintenance randomisation only). All patients and study site personnel were masked to treatment assignment. Primary endpoints were remission (Mayo Clinic total score [MCS] ≤2, with individual subscores of ≤1 and a rectal bleeding subscore of 0) at week 14, and remission at week 66 among patients with a clinical response (MCS with ≥3-point decrease and ≥30% reduction from baseline, plus ≥1 point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1) at week 14. Efficacy was analysed using a modified intent-to-treat population. Safety analyses included all patients who received at least one dose of study drug during the induction phase. This study is registered at ClinicalTrials.gov , NCT02100696 . Findings HICKORY was conducted from May 21, 2014, to April 16, 2020, during which time 1081 patients were screened, and 609 deemed eligible for inclusion. 130 patients were included in cohort 1. In cohort 2,479 patients were randomly assigned to the induction phase (etrolizumab n=384, placebo n=95). 232 patients were randomly assigned to the maintenance phase (etrolizumab to etrolizumab n=117, etrolizumab to placebo n=115). At week 14, 71 (18·5%) of 384 patients in the etrolizumab group and six (6·3%) of 95 patients in the placebo group achieved the primary induction endpoint of remission (p=0·0033). No significant difference between etrolizumab and placebo was observed for the primary maintenance endpoint of remission at week 66 among patients with a clinical response at week 14 (27 [24·1%] of 112 vs 23 [20·2%] of 114; p=0·50). Four patients in the etrolizumab group reported treatment-related adverse events leading to treatment discontinuation. The proportion of patients reporting at least adverse event was similar between treatment groups for induction (etrolizumab 253 [66%] of 384; placebo 63 [66%] of 95) and maintenance (etrolizumab to etrolizumab 98 [88%] of 112; etrolizumab to placebo 97 [85%] of 114). The most common adverse event in both groups was ulcerative colitis flare. Most adverse events were mild or moderate. During induction, the most common serious adverse event was ulcerative colitis flare (etrolizumab ten [3%] of 384; placebo: two [2%] of 95). During maintenance, the most common serious adverse event in the etrolizumab to etrolizumab group was appendicitis (two [2%] of 112) and the most common serious adverse events in the etrolizumab to placebo group were ulcerative colitis flare (two [2%] of 114) and anaemia (two [2%] of 114). Interpretation HICKORY demonstrated that a significantly higher proportion of patients with moderately to severely active ulcerative colitis who had been previously treated with anti-TNF agent were able to achieve remission at week 14 when treated with etrolizumab compared with placebo; however, there was no significant difference between groups in remission at week 66 among patients with a clinical response at week 14. Funding F Hoffmann-La Roche.
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- 2022
14. A Global Perspective on Gastric Cancer Screening: Which Concepts Are Feasible, and When?
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Wladyslaw Januszewicz, Maryla Helena Turkot, Peter Malfertheiner, and Jaroslaw Regula
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Cancer Research ,Oncology - Abstract
Background: Gastric cancer (GC) remains the fifth most common cancer and the third most common cause of cancer-related death globally. In 2022, GC fell into the scope of the updated EU recommendations for targeted cancer screening. Given the growing awareness of the GC burden, we aimed to review the existing screening strategies for GC in high-risk regions and discuss potentially applicable modalities in countries with low-to-intermediate incidence. Methods: The references for this Review article were identified through searches of PubMed with the search terms “gastric cancer”, “stomach cancer”, “Helicobacter pylori”, and “screening” over the period from 1995 until August 2022. Results: As Helicobacter pylori (H. pylori)-induced gastritis is the primary step in the development of GC, the focus on GC prevention may be directed toward testing for and treating this infection. Such a strategy may be appealing in countries with low- and intermediate- GC incidence. Other biomarker-based approaches to identify at-risk individuals in such regions are being evaluated. Within high-incidence areas, both primary endoscopic screening and population-based H. pylori “test-and-treat” strategies represent cost-effective models. Conclusions: Given the significant variations in GC incidence and healthcare resources around the globe, screening strategies for GC should be adjusted to the actual conditions in each region. While several proven tools exist for accurate GC diagnosis, a universal modality for the screening of GC populations remains elusive.
- Published
- 2023
15. How to Prepare Educational Lecture: EAGEN 50 Years of Experience
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Jaroslaw Regula
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Motivation ,Medical education ,business.industry ,Gastroenterology ,Endoscopy ,General Medicine ,Medical teaching ,law.invention ,Europe ,law ,ComputingMilieux_COMPUTERSANDEDUCATION ,CLARITY ,Humans ,Medicine ,Nutritional Physiological Phenomena ,Form of the Good ,business - Abstract
Background: European Association of Gastroenterology, Endoscopy, and Nutrition for 50 years provided a good, professional teaching of gastroenterology across Europe by world-known experts. Teaching tips and tricks to achieve maximum effects are summarized in this review article. Summary: The good speaker should be motivated to teach the audience at the time of lecture a topic in way that information provided is remembered. The educational aim should realistic, well selected, and precisely defined. Putting an order and clarity into information provided are crucial. Speaker should feel comfortable during lecture and enjoy it. Ways to achieve that are described in this review paper. Key Messages: Medical teaching by lectures should be simple, clear, well-structured, and enjoyable.
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- 2019
16. Comparison of Quality Measures for Detection of Neoplasia at Screening Colonoscopy
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Paulina Wieszczy, Marek Bugajski, Wladyslaw Januszewicz, Maria Rupinska, Jakub Szlak, Malgorzata Pisera, Maryla H. Turkot, Maciej Rupinski, Urszula Wojciechowska, Joanna Didkowska, Jaroslaw Regula, and Michal F. Kaminski
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Male ,Risk ,Adenoma ,Hepatology ,Gastroenterology ,Humans ,Mass Screening ,Female ,Colonoscopy ,Middle Aged ,Colorectal Neoplasms ,Early Detection of Cancer ,Quality Indicators, Health Care - Abstract
The proportion of colonoscopies with at least one adenoma (adenoma detection rate [ADR]) is inversely associated with colorectal cancer (CRC) risk and death. The aim of this study was to examine whether such associations exist for colonoscopy quality measures other than ADR.We used data from the Polish Colorectal Cancer Screening Program collected in 2000-2011. For all endoscopists who performed ≥100 colonoscopies we calculated detection rates of adenomas (ADR), polyps (PDR), and advanced adenomas (≥10 mm/villous component/high-grade dysplasia [AADR]); and number of adenomas per colonoscopy (APC) and per colonoscopy with ≥1 adenoma (APPC). We followed patients until CRC diagnosed before recommended surveillance, death, or December 31, 2019. We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) using Cox proportional-hazard models. We used Harrell's C statistic to compare the predictive power of the quality measures.Data on 173,287 patients (median age, 56 years; 37.8% male) and 262 endoscopists were used. During a median follow-up of 10 years and 1,490,683 person-years, we identified 395 CRCs. All quality measures were significantly associated with CRC risk and death. The relative reductions in CRC risk were as follows: for ADR ≥24.9% (reference12.1%; HR, 0.41; 95% CI, 0.25-0.66), PDR ≥42.7% (reference19.9%; HR, 0.35; 95% CI, 0.24-0.51), AADR ≥9.1% (reference4.1%; HR, 0.69; 95% CI, 0.49-0.96), APC ≥0.37 (reference0.15; HR, 0.35; 95% CI, 0.21-0.58), and APPC ≥1.54 (reference1.19; HR, 0.54; 95% CI, 0.35-0.83). AADR was the only quality measure with significantly lower predictive power than ADR (Harrell's C, 59.7 vs 63.4; P = .001). Similar relative reductions were observed for CRC death.This large observational study confirmed the inverse association between ADR and CRC risk and death. The PDR and APC quality measures appear to be comparable with ADR.
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- 2021
17. Proton pump inhibitors and colorectal cancer: A systematic review
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Jarek Kobiela, Jaroslaw Regula, Agastya Patel, Magdalena Antoszewska, and Piotr Spychalski
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Proton ,Systematic Reviews ,Colorectal cancer ,business.industry ,Carcinogenesis ,Gastroenterology ,Leucovorin ,Proton Pump Inhibitors ,General Medicine ,Proton pump inhibitor ,medicine.disease ,Cancer epidemiology ,Cancer research ,medicine ,Humans ,Translational medicine ,Fluorouracil ,business ,Colorectal Neoplasms ,Capecitabine - Abstract
BACKGROUND The use of proton pump inhibitors (PPI) is common worldwide, with reports suggesting that they may be overused. Several studies have found that PPI may affect colorectal cancer (CRC) risk. AIM To summarize current knowledge on the relationship between PPI and CRC from basic research, epidemiological and clinical studies. METHODS This systematic review was based on the patients, interventions, comparisons, outcome models and performed according to PRISMA guidelines. MEDLINE, EMBASE, Scopus, and Web of Science databases were searched from inception until May 17, 2021. The initial search returned 2591 articles, of which, 28 studies met the inclusion criteria for this review. The studies were categorized as basic research studies (n = 12), epidemiological studies (n = 11), and CRC treatment studies (n = 5). The quality of the included studies was assessed using the Newcastle-Ottawa Scale or Cochrane Risk of Bias 2.0 tool depending on the study design. RESULTS Data from basic research indicates that PPI do not stimulate CRC development via the trophic effect of gastrin but instead may paradoxically inhibit it. These studies also suggest that PPI may have properties beneficial for CRC treatment. PPI appear to have anti-tumor properties (omeprazole, pantoprazole), and are potential T lymphokine-activated killer cell-originated protein kinase inhibitors (pantoprazole, ilaprazole), and chemosensitizing agents (pantoprazole). However, these mechanisms have not been confirmed in human trials. Current epidemiological studies suggest that there is no causal association between PPI use and increased CRC risk. Treatment studies show that concomitant PPI and capecitabine use may reduce the efficacy of chemotherapy resulting in poorer oncological outcomes, while also suggesting that pantoprazole may have a chemosensitizing effect with the fluorouracil, leucovorin, oxaliplatin (FOLFOX) regimen. CONCLUSION An unexpected inhibitory effect of PPI on CRC carcinogenesis by way of several potential mechanisms is noted. This review identifies that different PPI agents may have differential effects on CRC treatment, with practical implications. Prospective studies are warranted to delineate this relationship and assess the role of individual PPI agents.
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- 2021
18. Clinical stages of colorectal cancer diagnosed in obese and overweight individuals in the Polish Colonoscopy Screening Program
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Jarek Kobiela, Jaroslaw Regula, Paulina Wieszczy, Piotr Spychalski, and Michal F. Kaminski
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Adult ,Male ,medicine.medical_specialty ,Colorectal cancer ,Colonoscopy ,Kaplan-Meier Estimate ,Overweight ,Body Mass Index ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Internal medicine ,Prevalence ,medicine ,Humans ,Mass Screening ,Obesity ,Risk factor ,neoplasms ,Early Detection of Cancer ,Aged ,Neoplasm Staging ,medicine.diagnostic_test ,business.industry ,Gastroenterology ,Original Articles ,Middle Aged ,medicine.disease ,digestive system diseases ,Cross-Sectional Studies ,Oncology ,030220 oncology & carcinogenesis ,Female ,030211 gastroenterology & hepatology ,Poland ,medicine.symptom ,Colorectal Neoplasms ,business - Abstract
BACKGROUND: Obesity is a known risk factor of colorectal cancer (CRC). However, precise interconnections between excessive body fat and CRC are still vague. Therefore, the aim of this study was to assess whether stage of CRC detected in overweight and obese individuals differs from individuals with normal body mass index (BMI). A secondary aim of this study was to elucidate whether overweight and obesity influence the overall survival in CRC. METHODS: This study was a cross-sectional analysis of 163,129 individuals who underwent screening colonoscopy performed on data from a prospectively maintained database of the Polish Colonoscopy Screening Program. RESULTS: Overweight and obese individuals present with a less advanced CRC in screening setting (p = 0.014). This trend is the most pronounced in males (p = 0.001). Univariable and multivariable analyses revealed that obesity was a negative predictor of detection of advanced CRC with odds ratio 0.72 (95% confidence interval 0.52–1.00; p = 0.047). Furthermore, overweight and obesity were not statistically significant predictors of risk of death (p = 0.614 and p = 0.446, respectively). CONCLUSIONS: Obese screenees present with a less advanced disease in comparison to non-obese. Moreover, survival stratified by clinical stage seems to not be influenced by BMI category. Therefore, a higher proportion of early diagnosed cancers can potentially create a survival benefit in this group.
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- 2019
19. The impact of low- versus standard-volume bowel preparation on participation in primary screening colonoscopy: a randomized health services study
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Marcin Polkowski, Anna Chaber-Ciopinska, Jaroslaw Regula, Maciej Rupinski, Slawomir Kielek, Jarosław Kobiela, Paulina Wieszczy, Zbigniew Kula, Bronisław Kotowski, Malgorzata Pisera, Michal F. Kaminski, Maria Rupinska, Robert Franczyk, and Marek Buszkiewicz
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Male ,medicine.medical_specialty ,Sodium picosulfate ,Population ,Colonoscopy ,Citric Acid ,Polyethylene Glycols ,law.invention ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Organometallic Compounds ,Humans ,Mass Screening ,Medicine ,Citrates ,education ,Mass screening ,education.field_of_study ,medicine.diagnostic_test ,Cathartics ,business.industry ,Gastroenterology ,Health services research ,Middle Aged ,Regimen ,chemistry ,030220 oncology & carcinogenesis ,Picolines ,Bowel preparation ,Patient Compliance ,Female ,030211 gastroenterology & hepatology ,Health Services Research ,Poland ,business - Abstract
Background The aim of this study was to evaluate the impact of low-volume vs. standard-volume bowel preparation on participation in screening colonoscopy, bowel preparation quality, and lesion detection rates. Methods This was a multicenter, randomized, health services study within the population-based primary colonoscopy screening program in Poland. Individuals aged 55 – 62 years were randomized in a 1:1 ratio to bowel preparation with a low-volume (0.3 L sodium picosulfate with magnesium citrate) or standard-volume (4 L polyethylene glycol) regimen and then invited to participate in screening colonoscopy. The primary outcome measure was the rate of participation in screening colonoscopy. Compliance with the assigned bowel preparation, bowel preparation quality, and lesion detection rates were also evaluated. Results A total of 13 621 individuals were randomized and 13 497 were analyzed (6752 in the low-volume group and 6745 in the standard-volume group). The participation rate (16.6 % vs. 15.5 %; P = 0.08) and compliance rate (93.3 % vs. 94.1 %; P = 0.39) did not differ significantly between the groups. In the low-volume group, fewer participants had adequate bowel preparation compared with the standard-volume group (whole colon 79.0 % vs. 86.4 %, P Conclusion When compared with a standard-volume bowel preparation with polyethylene glycol, low-volume bowel preparation with sodium picosulfate/magnesium citrate did not improve participation rate or lesion detection rates, and negatively affected bowel preparation quality.
- Published
- 2019
20. Implications of different guidelines for surveillance after serrated polyp resection in United States of America and Europe
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Joep E. G. IJspeert, Evelien Dekker, Arne Bleijenberg, Louise Emilsson, Øyvind Holme, Dagmar Klotz, Magnus Løberg, Hans-Olov Adami, Ernst J. Kuipers, Leif Løvdal, Else M. Løberg, Mette Kalager, Britta Kleist, Jaroslaw Regula, Michael Bretthauer, Gastroenterology & Hepatology, APH - Quality of Care, CCA - Cancer Treatment and Quality of Life, Gastroenterology and Hepatology, and AGEM - Re-generation and cancer of the digestive system
- Subjects
Adenoma ,Male ,medicine.medical_specialty ,Colorectal cancer ,Colonic Polyps ,Colonoscopy ,Resection ,03 medical and health sciences ,0302 clinical medicine ,otorhinolaryngologic diseases ,medicine ,Humans ,neoplasms ,Retrospective Studies ,medicine.diagnostic_test ,business.industry ,General surgery ,Serrated polyp ,Gastroenterology ,Retrospective cohort study ,Middle Aged ,medicine.disease ,United States ,digestive system diseases ,Europe ,Hyperplastic Polyp ,Population Surveillance ,030220 oncology & carcinogenesis ,Practice Guidelines as Topic ,Cohort ,Female ,030211 gastroenterology & hepatology ,Colorectal Neoplasms ,business - Abstract
Introduction Because individuals with serrated polyps and adenomas are at increased risk of developing new polyps and colorectal cancer (CRC), surveillance after resection is justified. After adenoma resection, most international guidelines are consistent, but recommendations for surveillance after serrated polyp resection vary. The United States Multi-Society Taskforce on CRC (US-MSTF) base surveillance intervals on serrated polyp subtype (traditional serrated adenoma, sessile serrated polyp, hyperplastic polyps), while the European Society of Gastrointestinal Endoscopy (ESGE) guidelines do not take serrated polyp subtype into account. We evaluated the implications of this difference in a primary colonoscopy screening cohort. Methods We included participants from a large colonoscopy screening trial. In a post-hoc simulation, assuming full protocol adherence, we determined the surveillance interval for each subject based on their polyp burden, using the most recent US-MSTF and ESGE guidelines. Results We included 5323 participants, of whom 1228 had one or more serrated polyps. In 5201 of all participants (98 %; Cohen’s kappa 0.90) and in 1106 of those with serrated polyps (90 %; Cohen’s kappa 0.80), both guidelines recommended identical surveillance intervals. Recommendations for a 3-year surveillance interval were identical between the two guidelines. All 122 subjects with discordant recommendations would receive a follow-up colonoscopy after 10 years using ESGE guidance and after 5 years using US-MSTF guidance. Conclusion Despite the different criteria used to determine surveillance after serrated polyp resection, most individuals are recommended identical colonoscopy surveillance intervals whether following the ESGE or US-MSTF guidelines. This suggests that surveillance recommendations do not need to consider the serrated polyp subtype.
- Published
- 2019
21. Fit and Colonoscopy Uptake after the First Round of Testing in a Randomized Health Services Study Offering Competing Strategies for Colorectal Cancer Screening (Piccolino Study)
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Paulina Wieszczy, E Pawlak, Michal F. Kaminski, Nastazja Dagny Pilonis, Maciej Rupinski, Jaroslaw Regula, Marek Bugajski, and Malgorzata Pisera
- Subjects
medicine.medical_specialty ,Health services ,medicine.diagnostic_test ,Colorectal cancer screening ,business.industry ,Family medicine ,medicine ,Colonoscopy ,business - Published
- 2021
22. Endoscopic ultrasound-guided stent-in-stent placement for management of migrated hepaticogastrostomy stent
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Karolina Jasionek, Michal F. Kaminski, Marcin Polkowski, and Jaroslaw Regula
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Endoscopic ultrasound ,medicine.medical_specialty ,Cholestasis ,medicine.diagnostic_test ,business.industry ,medicine.medical_treatment ,Gastroenterology ,Stent ,Endosonography ,Biliary Tract Surgical Procedures ,Stent placement ,Hepaticogastrostomy ,medicine ,Humans ,Stents ,Radiology ,business ,Ultrasonography, Interventional - Published
- 2021
23. Cost-effectiveness of colonoscopy in the organized screening program
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Michal F. Kaminski, Cesare Hassan, Jaroslaw Regula, Andrzej Sliwczynski, Paulina Wieszczy, Anna Ciopinska-Chaber, Maciej Rupinski, Radosław Pastusiak, Bartłomiej Krzeczewski, Malgorzata Pisera, and Olga Krzeczewska
- Subjects
medicine.medical_specialty ,medicine.diagnostic_test ,Cost–benefit analysis ,business.industry ,Colorectal cancer ,Cost effectiveness ,Cost-Benefit Analysis ,Incidence (epidemiology) ,MEDLINE ,Colonoscopy ,medicine.disease ,Emergency medicine ,Internal Medicine ,Humans ,Mass Screening ,Medicine ,Poland ,business ,Early Detection of Cancer ,Health policy ,Mass screening - Abstract
Introduction Colorectal cancer (CRC) is a serious health problem, and various screening programs to reduce CRC have been introduced worldwide. However, the cost‑effectiveness of a program based on once‑in‑a‑lifetime colonoscopy in Poland is unknown. Objectives The main aim of this study was to assess the cost‑effectiveness of Polish Colonoscopy Screening Platform (PCSP), the colonoscopy screening program in Poland. Patients and methods A Markov model was constructed to compare the strategy of colonoscopy screening as compared with no screening in 100 000 subjects. The model was based on data collected from the nationwide Polish CRC screening program whenever possible. The incremental cost‑effectiveness ratio (ICER) was calculated and compared with the willingness‑to‑pay thresholds. A sensitivity analysis was also performed using the Monte Carlo simulation. Results Colonoscopy screening within PCSP resulted in a 18.9% reduction in CRC incidence and 19.8% reduction in CRC mortality. The strategy allowed a gain of 2317 life‑years saved (1959 after discount‑ ing). The cost of colonoscopy screening per participant examined was estimated at 267.70 USD (95% CI, 263.08-272.32 USD). The ICER was less than 6500 USD, which was much lower than the accepted willingness‑to‑pay thresholds, indicating that the screening was cost‑effective. Conclusions Colonoscopy screening within the PCSP is cost‑effective and may have a substantial impact on the Polish society due to life‑years saved. The results have good informative value not only for health policy makers and medical practitioners, but also for health technology assessment.
- Published
- 2021
24. RAPORT: III SPOTKANIE RADY EKSPERT��W DS. ONKOLOGII MEDYCZNEJ RACJI STANU
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Gierczy��ski, Jakub, Adamski, Jakub, Antoniewicz, Artur, Bidzi��ski, Mariusz, Ch��osta, Piotr, Czupryniak, Leszek, W��adys��aw Duda, Dziuk, Barbara, S��awomir Gadomski, Giannopoulos, Krzysztof, Gil, Lidia, Kosowicz, Mariola, Pawe�� Kowal, Kraj, Leszek, Krzakowski, Maciej, Lech-Maranda, Ewa, Lubi��ski, Jan, Maciejczyk, Adam, Rados��aw M��dry, Meder, Janusz, Mierzejewski, Piotr, Parkitna, Joanna, Pienkowski, Tadeusz, Pruszko, Cezary, Jaroslaw Regula, Rutkowski, Daniel, Schymalla, Iwona, Micha�� Sutkowski, Wechmann, Krystyna, and Pawe�� Wiechno
- Published
- 2021
- Full Text
- View/download PDF
25. Raport MRS HCV Sprawdzam-Wygrywam
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Gierczy��ski, Jakub, Flisiak, Robert, Kraj, Leszek, Ma��kowski, Piotr, Meder, Janusz, Pepke, Barbara, Piekarska, Anna, Jaroslaw Regula, Micha�� Sutkowski, Tomasiewicz, Krzysztof, and Wechmann, Krystyna
- Published
- 2021
- Full Text
- View/download PDF
26. 602: THRESHOLDS OF ADENOMA DETECTION RATE AND POST-COLONOSCOPY COLORECTAL CANCER RISK
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Nastazja D. Pilonis, Paulina Wieszczy, Marek Bugajski, Joanna A. Didkowska, Urszula E. Wojciechowska, Jaroslaw Regula, and Michal F. Kaminski
- Subjects
Hepatology ,Gastroenterology - Published
- 2022
27. Peroral Endoscopic Myotomy in the Management of Zenker's Diverticulum: A Retrospective Multicenter Study
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Michal F. Kaminski, Andrzej Białek, Jaroslaw Regula, Michal Spychalski, Wladyslaw Januszewicz, and Aleksandra Budnicka
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Myotomy ,medicine.medical_specialty ,Scoring system ,medicine.medical_treatment ,Zenker’s diverticulum ,lcsh:Medicine ,Cricopharyngeus myotomy ,Article ,submucosal tunneling endoscopic septum division ,Therapy naive ,03 medical and health sciences ,Zenker's diverticulum ,0302 clinical medicine ,Kothari-Haber scoring system ,medicine ,Adverse effect ,Symptom measurement ,business.industry ,lcsh:R ,Retrospective cohort study ,General Medicine ,medicine.disease ,peroral endoscopic myotomy ,Surgery ,Multicenter study ,030220 oncology & carcinogenesis ,030211 gastroenterology & hepatology ,business - Abstract
Background: Peroral endoscopic myotomy (POEM) is an emerging technique in the treatment of Zenker&rsquo, s diverticulum (ZD). This study aimed to analyze the feasibility of Zenker&rsquo, s POEM (Z-POEM) in a multicenter setting and assess its performance using a validated Kothari-Haber Scoring System newly developed for symptom measurement in ZD. Materials and methods: This was a multicenter retrospective study involving three Polish tertiary referral endoscopic units. The data of consecutive patients with symptomatic ZD treated with Z-POEM in Poland between May 2019 and August 2020 were retrieved and analyzed. Primary outcome measures were technical success and clinical success rate (<, 3 points in Kothari-Haber Score at 2&ndash, 3 months follow-up). Secondary outcome measures included procedures&rsquo, duration, length of hospital stay, and adverse events. Results: 22 patients with symptomatic ZD were included. The mean age was 67.6 (±, 10.7) years, and 14 (63.6%) were male. All but two patients were treatment naï, ve. The average size of the ZD was 30 mm (IQR, 24&ndash, 40 mm). Technical success was achieved in all patients (100%), whereas clinical success was 90.9%. The average Kothari-Haber Score was 6.35 before treatment and has dropped to 0.65 after the treatment (p <, 0.0001). The mean procedure time was 48.8 (±, 19.3) minutes, and the median length of hospital stay was 2 days (IQR, 2&ndash, 3). Three patients (13.6%) had post-procedural emphysema, of which two were mild and self-resolving (9.1%), and one was moderate (4.5%) and complicated with laryngeal edema and prolonged intubation. Conclusions: This feasibility study suggests that Z-POEM is a highly effective and safe treatment for ZD, particularly among treatment-naï, ve patients. Comparative studies with other treatment modalities over longer follow-up are warranted.
- Published
- 2020
28. Longitudinal analysis of healthy colon establishes aspirin as a suppressor of cancer-related epigenetic aging
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Kaspar Truninger, Anna Chaber-Ciopinska, Jaroslaw Regula, Faiza Noreen, and Primo Schär
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Epigenomics ,Oncology ,Aging ,Longitudinal study ,medicine.medical_specialty ,Colon ,Colorectal cancer ,Epigenesis, Genetic ,Internal medicine ,Genetics ,Humans ,Medicine ,Cyclooxygenase Inhibitors ,Longitudinal Studies ,Epigenetics ,Molecular Biology ,Early Detection of Cancer ,Genetics (clinical) ,Aged ,Aged, 80 and over ,Aspirin ,DNA methylation ,business.industry ,Incidence ,Research ,Cancer ,dNaM ,Methylation ,Middle Aged ,medicine.disease ,Healthy Volunteers ,Colon cancer ,Case-Control Studies ,Colonic Neoplasms ,CpG Islands ,Female ,business ,Follow-Up Studies ,Genome-Wide Association Study ,Developmental Biology ,medicine.drug - Abstract
Background Colon cancer (CC) is the third most common cancer worldwide, highlighting the importance of developing effective prevention strategies. Accumulating evidence supports that aspirin use reduces CC incidence. We reported previously that aspirin suppresses age-associated and CC-relevant DNA methylation (DNAm) in healthy colon. Here we addressed the aspirin’s effectiveness in longitudinal cohort. Methods We measured genome-wide DNAm in 124 healthy normal mucosa samples taken at baseline (time point 1, t1) and after 10-years follow-up (time point 2, t2) from a longitudinal female screening cohort. We investigated the time-dependent methylation drift in aspirin users and nonusers using multivariable regression and related the modulatory effect of aspirin to colonic epigenome-aging and CC. Results Over time, compared to nonusers, long-term (≥ 2 years) aspirin users showed less hypermethylated CpGs (proximal: 17% vs. 87%; distal: 16% vs. 70%) and more hypomethylated CpGs (proximal: 83% vs. 13%; distal: 84% vs. 30%). Overall, users showed 2% (P = 0.02) less mean methylation levels than nonusers in proximal colon and displayed repressed methylation age (mAge). Methylation loss in users occurred at several CC-specific tumor suppressors that gained methylation in nonusers. Methylation loss in users effected genes involved in immune system and inflammation, while methylation gain in nonusers effected genes involved in metabolism. Conclusions This is the first longitudinal study demonstrating effectiveness of aspirin-use in suppression of age-related and CC-relevant hypermethylation in the normal colon. These findings provide a rationale for future studies to evaluate loci that may serve as markers to identify individuals that will benefit most from aspirin and hence increase its efficiency in CC prevention and therapy.
- Published
- 2020
29. To Be Screened or Not to Be...? Psyche First?
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Jaroslaw Regula
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medicine.medical_specialty ,Psyche ,business.industry ,Colorectal cancer screening ,Neoplasms ,Family medicine ,Gastroenterology ,medicine ,MEDLINE ,Humans ,business ,Early Detection of Cancer - Published
- 2020
30. Participation in Competing Strategies for Colorectal Cancer Screening: A Randomized Health Services Study (PICCOLINO Study)
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Michal F. Kaminski, Marek Bugajski, Malgorzata Pisera, Jaroslaw Regula, Maciej Rupinski, Nastazja Dagny Pilonis, Paulina Wieszczy, and Edyta Pawlak
- Subjects
0301 basic medicine ,Male ,medicine.medical_specialty ,Colorectal cancer ,Colonoscopy ,Screening colonoscopy ,03 medical and health sciences ,Health services ,0302 clinical medicine ,Secondary outcome ,Primary outcome ,medicine ,Humans ,Mass Screening ,Early Detection of Cancer ,Neoplasm Staging ,Hepatology ,medicine.diagnostic_test ,Crc screening ,business.industry ,Gastroenterology ,Middle Aged ,medicine.disease ,030104 developmental biology ,Colorectal cancer screening ,Family medicine ,Occult Blood ,030211 gastroenterology & hepatology ,Female ,Poland ,Patient Participation ,business ,Colorectal Neoplasms - Abstract
Primary colonoscopy and fecal immunochemical testing (FIT) are considered first-tier tests for colorectal cancer (CRC) screening. Although colonoscopy is considered the most efficacious test, FIT might achieve higher participation rates. It is uncertain what the best strategy is for offering population-wide CRC screening.This was a multicenter randomized health services study performed within the framework of the Polish Colonoscopy Screening Program between January 2019 and March 2020 on screening-naïve individuals. Eligible candidates were randomly assigned in a 1:1:1 ratio to participate in 1 of 3 competing invitation strategies: control (invitation to screening colonoscopy only); sequential (invitation to primary colonoscopy and invitation for FIT for initial nonresponders); or choice (invitation offering a choice of colonoscopy or FIT). The primary outcome was participation in CRC screening within 18 weeks after enrollment into the study. The secondary outcome was diagnostic yield for advanced neoplasia.Overall, 12,485 individuals were randomized into the 3 study groups. The participation rate in the control group (17.5%) was significantly lower compared with the sequential (25.8%) and choice strategy (26.5%) groups (P.001 for both comparisons). The colonoscopy rates for participants with positive FITs were 70.0% for the sequential group and 73.3% for the choice group, despite active call-recall efforts. In the intention-to-screen analysis, advanced neoplasia detection rates were comparable among the control (1.1%), sequential (1.0%), and choice groups (1.1%).Offering a combination of FIT and colonoscopy as a sequential or active choice strategy increases participation in CRC screening. Increased participation in strategies with FIT do not translate into higher detection of advanced neoplasia. ClinicalTrials.gov, Number NCT03790475.
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- 2020
31. Correction: Argon plasma coagulation for Barrett's esophagus with low-grade dysplasia: a randomized trial with long-term follow-up on the impact of power setting and proton pump inhibitor dose
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Ewa Wronska, Marcin Polkowski, Janina Orlowska, Andrzej Mroz, Paulina Wieszczy, and Jaroslaw Regula
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Gastroenterology - Published
- 2020
32. DICA endoscopic classification: 2-year analysis from an international, multicenter prospective study
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Giovanni Brandimarte, Antonio Tursi, Marcello Picchio, Walter Elisei, G Nasi, Jaroslaw Regula, M. Bafutto, F. Di Mario, A M Mastromatteo, and Dan L. Dumitrascu
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Pediatrics ,medicine.medical_specialty ,business.industry ,Public Health, Environmental and Occupational Health ,medicine ,Prospective cohort study ,business - Abstract
Background Diverticulosis of the colon is the most frequent anatomical alteration detected during colonoscopy. The endoscopic classification “DICA”(Diverticular Inflammation and Complication Assessment) has been recently developed in order to have an objective endoscopic description of the colon harbouring diverticula. Aim of this multicentre, international, prospective study was to assess the predictive value of this classification in term of acute diverticulitis and surgery occurrence on a 2-year observational follow-up period. Methods 2215 prospective patients at the first diagnosis of diverticular disease were enrolled after exclusion of radiological signs of acute diverticulitis; inflammatory bowel diseases; ischemic colitis; prior colonic resection; patients with severe liver failure (Child-Pugh C) or severe kidney failure; pregnant women; patients who are currently using or who have received any laxative agents or mesalazine or probiotics or antibiotics < 2 weeks prior to the enrollment; inability to comply with study protocol; patients with or history of cancer, of any origin, within 5 years before enrollment; history of alcohol, drug, or chemical abuse. Results 1377(62.15%) patients were classified as DICA 1, 599(27,04%) as DICA 2 and 239(10.80%) as DICA 3. The risk of acute diverticulitis occurrence/recurrence, as well as the risk of surgery, were significantly linked to the severity of DICA score at entry. Overall, acute diverticulitis occurred in 123 (5,5%) patients: it occurred in 32 (2,3%) DICA 1, 53 (8,9%) DICA 2 and 32 (16.4%) DICA 3 patients respectively (p Conclusions The 2-year results of this prospective study seems to confirm that DICA endoscopic classification has a significant prognostic role on the risk of acute diverticulitis occurrence/recurrence and surgery in these patients. Key messages DICA is the first endoscopic classification of diverticular disease. The risk of occurrence/recurrence of acute diverticulitis and the risk of surgery are strictly linked to the severity of DICA score.
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- 2020
33. Transoral endoscopic ultrasound-guided fine-needle biopsy of a tumor of the parapharyngeal space
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Jakub Pałucki, Jakub Zwoliński, Kamil Sokół, Jaroslaw Regula, Marcin Polkowski, Jacek Lenartowicz, and Andrzej Mróz
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Endoscopic ultrasound ,Image-Guided Biopsy ,medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Biopsy, Fine-Needle ,Gastroenterology ,Fine needle biopsy ,Parapharyngeal Space ,Neoplasms ,Biopsy ,Parapharyngeal space ,Medicine ,Humans ,Radiology ,Ultrasonography ,business ,Endoscopic Ultrasound-Guided Fine Needle Aspiration ,Ultrasonography, Interventional - Published
- 2020
34. Colonoscopist Performance and Colorectal Cancer Risk After Adenoma Removal to Stratify Surveillance: Two Nationwide Observational Studies
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Magnus Løberg, Paulina Wieszczy, Maciej Rupinski, Monika Ferlitsch, Kathryn Gray, Michal F. Kaminski, Jaroslaw Regula, Michael Bretthauer, Elisabeth Waldmann, Mette Kalager, and Marek Bugajski
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0301 basic medicine ,Adenoma ,Male ,medicine.medical_specialty ,Colorectal cancer ,Colon ,Colonoscopy ,Colonic Polyps ,Gastroenterology ,Risk Assessment ,03 medical and health sciences ,0302 clinical medicine ,Interquartile range ,Risk Factors ,Internal medicine ,medicine ,Humans ,Mass Screening ,Cancer prevention ,Hepatology ,medicine.diagnostic_test ,business.industry ,Incidence (epidemiology) ,Incidence ,Hazard ratio ,Middle Aged ,medicine.disease ,Confidence interval ,030104 developmental biology ,Austria ,030211 gastroenterology & hepatology ,Female ,Clinical Competence ,Poland ,business ,Colorectal Neoplasms ,Follow-Up Studies - Abstract
Colonoscopy surveillance after adenoma removal is an increasing burden in many countries. Surveillance recommendations consider characteristics of removed adenomas, but not colonoscopist performance. We investigated the impact of colonoscopist performance on colorectal cancer risk after adenoma removal.We compared colorectal cancer risk after removal of high-risk adenomas, low-risk adenomas, and after negative colonoscopy for all colonoscopies performed by colonoscopists with low vs high performance quality (adenoma detection rate20% vs ≥20%) in the Polish screening program between 2000 and 2011, with follow-up until 2017. Findings were validated in the Austrian colonoscopy screening program.A total of 173,288 Polish colonoscopies were included in the study. Of 262 colonoscopists, 160 (61.1%) were low performers, and 102 (38.9%) were high performers; 11.1% of individuals had low-risk and 6.6% had high-risk adenomas removed at screening; 82.2% had no adenomas. During 10 years of follow-up, 443 colorectal cancers were diagnosed. For low-risk adenoma individuals, colorectal cancer incidence was 0.55% (95% confidence interval [CI] 0.40-0.75) with low-performing colonoscopists vs 0.22% (95% CI 0.14-0.34) with high-performing colonoscopists (hazard ratio [HR] 2.35; 95% CI 1.31-4.21; P = .004). For individuals with high-risk adenomas, colorectal cancer incidence was 1.14% (95% CI 0.87-1.48) with low-performing colonoscopists vs 0.43% (95% CI 0.27-0.69) with high-performing colonoscopists (HR 2.69; 95% CI 1.62-4.47; P.001). After negative colonoscopy, colorectal cancer incidence was 0.30% (95% CI 0.27-0.34) for individuals examined by low-performing colonoscopists, vs 0.15% (95% CI 0.11-0.20) for high-performing (HR 2.10; 95% CI 1.52-2.91; P.001). The observed trends were reproduced in the Austrian validation cohort.Our results suggest that endoscopist performance may be an important contributor in addition to polyp characteristics in determining colorectal cancer risk after colonoscopy screening.
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- 2020
35. Additional file 1 of Longitudinal analysis of healthy colon establishes aspirin as a suppressor of cancer-related epigenetic aging
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Noreen, Faiza, Chaber-Ciopinska, Anna, Jaroslaw Regula, Schär, Primo, and Truninger, Kaspar
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animal structures ,embryonic structures ,human activities - Abstract
Additional file 1. Figure S1. a) Overlap of all significant differentially methylated CpGs found in aspirin users and nonusers. The non-overlapping CpGs were then defined as aspirin user specific differentially methylated CpGs (U-dmCpGs) or nonuser specific differentially methylated CpGs (Nu-dmCpGs). b) Overlap of genes affected by Nu-dmCpGs and U-dmCpGs with known differential expressed colon cancer specific tumor suppressor genes (TSGs) and oncogenes. Shown are separate overlaps for proximal and distal colon.
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- 2020
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36. Increased Rate of Adenoma Detection Associates With Reduced Risk of Colorectal Cancer and Death
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Michal F. Kaminski, Bartlomiej R. Kocot, Jacek Pachlewski, Paulina Wieszczy, Anna Chaber-Ciopinska, Marcin Polkowski, Maciej Rupinski, Jarosław Kobiela, Urszula Wojciechowska, Jaroslaw Regula, Joanna Didkowska, Maria Rupinska, Ewa Kraszewska, and Robert Franczyk
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Adenoma ,Male ,medicine.medical_specialty ,Reduced risk ,Colorectal cancer ,Colonoscopy ,Adenocarcinoma ,Feedback ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Internal medicine ,medicine ,Humans ,Prospective Studies ,Prospective cohort study ,Early Detection of Cancer ,Gynecology ,Hepatology ,medicine.diagnostic_test ,business.industry ,Hazard ratio ,Gastroenterology ,Middle Aged ,medicine.disease ,Quality Improvement ,Confidence interval ,Cancer registry ,Benchmarking ,Editorial ,030220 oncology & carcinogenesis ,Female ,030211 gastroenterology & hepatology ,Poland ,Colorectal Neoplasms ,business - Abstract
Background & Aims The quality of endoscopists' colonoscopy performance is measured by adenoma detection rate (ADR). Although ADR is associated inversely with interval colorectal cancer and colorectal cancer death, the effects of an increasing ADR have not been shown. We investigated whether increasing ADRs from individual endoscopists is associated with reduced risks of interval colorectal cancer and subsequent death. Methods We performed a prospective cohort study of individuals who underwent a screening colonoscopy within the National Colorectal Cancer Screening Program in Poland, from January 1, 2004, through December 31, 2008. We collected data from 146,860 colonoscopies performed by 294 endoscopists, with each endoscopist having participated at least twice in annual editions of primary colonoscopy screening. We used annual feedback and quality benchmark indicators to improve colonoscopy performance. We used ADR quintiles in the whole data set to categorize the annual ADRs for each endoscopist. An increased ADR was defined as an increase by at least 1 quintile category, or the maintenance of the highest category in subsequent screening years. Multivariate frailty models were used to evaluate the effects of increased ADR on the risk of interval colorectal cancer and death. Results Throughout the enrollment period, 219 endoscopists (74.5%) increased their annual ADR category. During 895,916 person-years of follow-up evaluation through the National Cancer Registry, we identified 168 interval colorectal cancers and 44 interval cancer deaths. An increased ADR was associated with an adjusted hazard ratio for interval colorectal cancer of 0.63 (95% confidence interval [CI], 0.45–0.88; P = .006), and for cancer death of 0.50 (95% CI, 0.27–0.95; P = .035). Compared with no increase in ADR, reaching or maintaining the highest quintile ADR category (such as an ADR > 24.56%) decreased the adjusted hazard ratios for interval colorectal cancer to 0.27 (95% CI, 0.12–0.63; P = .003), and 0.18 (95% CI, 0.06–0.56; P = .003), respectively. Conclusions In a prospective study of individuals who underwent screening colonoscopy within a National Colorectal Cancer Screening Program, we associated increased ADR with a reduced risk of interval colorectal cancer and death.
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- 2017
37. Adenocarcinoma of the cervical esophagus arising within a long segment of Barrett’s metaplasia
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Krzysztof Trzebinski, Michal F. Kaminski, Wladyslaw Januszewicz, Jaroslaw Regula, Anna Cencelewicz-Lesikow, and Małgorzata Lenarcik
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Metaplasia ,Pathology ,medicine.medical_specialty ,2019-20 coronavirus outbreak ,Esophageal Neoplasms ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Gastroenterology ,Adenocarcinoma ,Long segment ,medicine.disease ,Barrett Esophagus ,Esophagus ,medicine ,Humans ,Cervical esophagus ,medicine.symptom ,business - Published
- 2020
38. Key performance measures for colonoscopy in the Polish Colonoscopy Screening Program
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Michal F. Kaminski, Maciej Rupinski, Paulina Wieszczy, Jaroslaw Regula, Malgorzata Pisera, and Marek Bugajski
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Adenoma ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,MEDLINE ,Colonoscopy ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Humans ,Early Detection of Cancer ,Gastrointestinal endoscopy ,Quality Indicators, Health Care ,Retrospective Studies ,medicine.diagnostic_test ,business.industry ,Gastroenterology ,Retrospective cohort study ,Guideline ,Middle Aged ,Polypectomy ,Patient feedback ,Data extraction ,030220 oncology & carcinogenesis ,Emergency medicine ,030211 gastroenterology & hepatology ,Female ,Poland ,business ,Colorectal Neoplasms - Abstract
Background The European Society of Gastrointestinal Endoscopy (ESGE) has published guidelines on key performance measures for colonoscopy. We analyzed whether those standards were met in the Polish Colonoscopy Screening Program (PCSP) and whether the monitoring was feasible. Methods We analyzed database records for 43 277 PCSP participants (25 PCSP centers) for the years 2014 – 2015. We used the guideline definitions to calculate values for all key performance measures and compared these with the proposed standards at individual, center, and program level. All data were acquired from the PCSP database, apart from complication data which was assessed from external registries. Results At the program level, four of five minimum standards and one of two target standards (no set minimum standard) were met. Adequate bowel preparation rate was 91.3 % for the whole program (range among individual centers 79.2 % – 99.2 %). Cecal intubation rate was 97.4 % (93.4 % – 99.4 %). Adenoma detection rate was 29.8 % (19.1 % – 39.1 %). An appropriate polypectomy technique was applied in 62.7 % of cases (0.4 % – 97.8 %). Regarding complications, 7-day hospitalization rate after screening colonoscopy was 0.3 % (n = 127), and 30-day all-cause mortality was 0.02 % (n = 9). Patient feedback was assessed in 66.2 % of colonoscopies (7.6 % – 81.8 %). Appropriate post-polypectomy surveillance was proposed in 95.4 % of cases (range 84.9 % – -99.7 %). It was easy to monitor 6 of 7 key performance measures within the PCSP database, but monitoring complications required the additional effort of data extraction from external registries. Conclusions The PCSP meets most proposed minimum standards at program level. Some centers need additional interventions to meet the complete set of quality standards. Use of ESGE performance measures for monitoring colonoscopy is generally feasible in the setting of the colonoscopy screening program.
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- 2019
39. Endoscopist biopsy rate as a quality indicator for outpatient gastroscopy: a multicenter cohort study with validation
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Wladyslaw Januszewicz, Michal F. Kaminski, Jaroslaw Regula, Katarzyna Karpińska, Paulina Wieszczy, Maciej Rupinski, Jakub Szlak, Andrzej Mróz, Andrzej Białek, Jakub Szymonik, and Apollo - University of Cambridge Repository
- Subjects
Adenoma ,Adult ,Gastritis, Atrophic ,Male ,medicine.medical_specialty ,Adolescent ,Biopsy ,Squamous Intraepithelial Lesions ,Information Storage and Retrieval ,Logistic regression ,Gastroenterology ,Cohort Studies ,03 medical and health sciences ,Barrett Esophagus ,Young Adult ,0302 clinical medicine ,Duodenal Neoplasms ,Stomach Neoplasms ,Internal medicine ,Gastroscopy ,medicine ,Ambulatory Care ,Humans ,Radiology, Nuclear Medicine and imaging ,Sampling (medicine) ,Aged ,Quality Indicators, Health Care ,Retrospective Studies ,Metaplasia ,medicine.diagnostic_test ,business.industry ,Stomach ,Odds ratio ,Middle Aged ,Confidence interval ,Cancer registry ,Logistic Models ,Quartile ,030220 oncology & carcinogenesis ,Multivariate Analysis ,030211 gastroenterology & hepatology ,Female ,Poland ,business ,Precancerous Conditions ,Cohort study - Abstract
BACKGROUND AND AIMS: The diagnosis of gastric premalignant conditions (GPCs) relies on endoscopy with mucosal sampling. We hypothesized that the endoscopist biopsy rate (EBR) might constitute a quality indicator for EGD, and we have analyzed its association with GPC detection and the rate of missed gastric cancers (GCs). METHODS: We analyzed EGD databases from 2 high-volume outpatient units. EBR values, defined as the proportion of EGDs with ≥1 biopsy to all examinations were calculated for each endoscopist in Unit A (derivation cohort) and divided by the quartile values into 4 groups. Detection of GPC was calculated for each group and compared using multivariate clustered logistic regression models. Unit B database was used for validation. All patients were followed in the Cancer Registry for missed GCs diagnosed between 1 month and 3 years after EGDs with negative results. RESULTS: Sixteen endoscopists in Unit A performed 17,490 EGDs of which 15,340 (87.7%) were analyzed. EBR quartile values were 22.4% to 36.7% (low EBR), 36.8% to 43.7% (moderate), 43.8% to 51.6% (high), and 51.7% and 65.8% (very-high); median value 43.8%. The odds ratios for the moderate, high, and very-high EBR groups of detecting GPC were 1.6 (95% confidence interval [CI], 1.3-1.9), 2.0 (95% CI, 1.7-2.4), and 2.5 (95% CI, 2.1-2.9), respectively, compared with the low EBR group (P < .001). This association was confirmed with the same thresholds in the validation cohort. Endoscopists with higher EBR (≥43.8%) had a lower risk of missed cancer compared with those in the lower EBR group (odds ratio, 0.44; 95% CI, 0.20-1.00; P = .049). CONCLUSIONS: The EBR parameter is highly variable among endoscopists and is associated with efficacy in GPC detection and the rate of missed GCs.
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- 2019
40. IDDF2019-ABS-0111 Colorectal cancers detected following surgery at anastomoses or other colorectal locations during colonoscopy surveillance – a systematic review and meta-analysis
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Cesare Hassan, L Correale, Maria Pellise, Thierry Ponchon, Rodrigo Jover, Thomas Rösch, Jeanin E. van Hooft, Pradeep Bhandari, Diogo Libanio, Jaroslaw Regula, Lorenzo Fuccio, Leonardo Frazzoni, Franco Radaelli, Alessandro Repici, Douglas K. Rex, Mário Dinis-Ribeiro, Sergio Alfieri, Prateek Sharma, Carlo Senore, Evelien Dekker, Thomas Seufferlein, and Franco Bazzoli
- Subjects
medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Colorectal cancer ,Incidence (epidemiology) ,Colonoscopy ,Retrospective cohort study ,Odds ratio ,Anastomosis ,medicine.disease ,digestive system diseases ,Surgery ,medicine ,Cumulative incidence ,Stage (cooking) ,business ,neoplasms - Abstract
Background Outcomes of endoscopic surveillance following surgery for colorectal cancer (CRC) vary with the incidence and timing of CRC detection, at anastomosis or elsewhere in the colorectum. We performed systematic review and meta-analysis to evaluate the incidence of CRCs identified during surveillance colonoscopies of patients with previous CRC surgery. Methods We searched PubMed, EMBASE, SCOPUS, and the Cochrane Central Register through January 1, 2018, to identify studies investigating rates of CRCs at anastomoses or other colorectal locations after curative surgery for primary CRC. We collected data from randomized controlled, prospective, and retrospective cohort studies. Data were analyzed by multivariate meta-analytic models. Results From 2,373 citations, we selected 27 studies with 15,803 index CRCs (89% stage I-III CRCs). Overall, 296 CRCs at non-anastomotic locations were reported over time periods of more than 16 years (cumulative incidence, 2.2% of CRCs; 95% CI, 1.8%-2.9%). The risk of non-anastomotic CRC is shown in figure A (figure 1A) and significantly decreased after 36 months or more from resection, compared with that before this time point (odds ratio for non-anastomotic CRCs at 36–48 months vs 6–12 months after surgery, 0.61; 95% CI, 0.37–0.98; P=.031); 53.7% of all non-anastomotic CRCs were detected within 36 months from surgery. One hundred fifty-eight anastomotic CRCs were detected over more than 16-years follow-up (cumulative incidence of 2.7%; 95% CI, 1.9%-3.9%). The risk of anastomotic CRCs is shown in figure B (figure 1B), and was significantly lower after 24 months or more from resection than before (odds ratio for CRCs at anastomoses at 25–36 months after surgery vs. 6–12 months, 0.56; 95% CI, 0.32–0.98; P=.036); 90.8% of anastomotic CRCs were detected within 36 months from surgery. Conclusions After surgery for CRC, the highest risk of anastomotic and non-anastomotic CRCs is highest during 36 months after surgery - risk decreases thereafter. Patients who have undergone CRC resection should be evaluated by colonoscopy more closely during this time period. Longer intervals may be considered thereafter.
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- 2019
41. Response
- Author
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Wladyslaw Januszewicz and Jaroslaw Regula
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Cohort Studies ,Biopsy ,Gastroscopy ,Outpatients ,Gastroenterology ,Humans ,Radiology, Nuclear Medicine and imaging - Published
- 2019
42. Mortality and Rate of Hospitalization in a Colonoscopy Screening Program From a Randomized Health Services Study
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Paulina Wieszczy, Jarek Kobiela, Jaroslaw Regula, Maciej Rupinski, Nastazja Dagny Pilonis, Malgorzata Pisera, Marek Bugajski, Michal F. Kaminski, and Piotr Spychalski
- Subjects
medicine.medical_specialty ,Colorectal cancer ,Colonoscopy ,03 medical and health sciences ,Health services ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Mass Screening ,Adverse effect ,Early Detection of Cancer ,Intention-to-treat analysis ,Hepatology ,medicine.diagnostic_test ,business.industry ,Gastroenterology ,Absolute risk reduction ,Middle Aged ,medicine.disease ,Hospitalization ,030220 oncology & carcinogenesis ,030211 gastroenterology & hepatology ,Poland ,Complication ,business ,Colorectal Neoplasms ,Screening intervention - Abstract
It is difficult to quantify adverse events related to screening colonoscopy due to lack of valid and adequately powered comparison groups. We compared mortality and rate of unplanned hospitalizations among subjects who underwent screening colonoscopies within the Polish Colonoscopy Screening Program (PCSP) vs unscreened matched controls in Poland.Persons 55-64 years old living in the area covered by the PCSP from 2012 through 2015 were assigned in a (1:1) to a group invited for screening colonoscopy (n = 338,477) or a matched group that would be invited 5 years later (controls, n = 338,557). All subjects in the screening group were assigned proposed screening colonoscopy dates (actual dates when invitees confirmed or rescheduled colonoscopy) and those in the control group were assigned virtual dates corresponding to the matched individuals from the screening group. In the screening group, 55,390 subjects (16.4%) underwent screening colonoscopy. Mortality and hospitalization data were obtained from National Registries. We compared mortality and rate of hospitalization between the groups for defined intervals before and after colonoscopy date. Hospitalizations were divided into related and unrelated to colonoscopy based on ICD codes by 3 specialists. Our primary aim was to compare mortality and hospitalization 6 weeks before and 30 days following the actual or virtual date of colonoscopy in the screening or control group.In the intent to treat analysis, overall there were no significant differences in mortality between the colonoscopy group and control group (0.22% vs 0.22%; risk difference less than .01%; 95% CI, decrease of 0.02% to 0.02%; P = .913). The overall rate of unplanned hospitalization was significantly higher for the colonoscopy group (2.39% vs 2.31% for the control group; risk difference, 0.08%; 95% CI, 0.01%-0.15%; P=.026) for the entire observation period. This was due to the higher rate of hospitalizations after screening (1.10% vs 1.01% for the control group; risk difference, 0.09%; 95% CI, 0.04%-0.14%; P.001) including higher proportion of hospitalizations that were assessed as related to colonoscopy (0.24% vs 0.22% for the control group; risk difference, 0.02%; 95% CI, 0.00%-0.05%; P = .046). In the per-protocol analysis, the overall rate of hospitalizations did not differ significantly between control and screening colonoscopy groups (1.87% vs 1.90%; P=.709). However, screening colonoscopy did increase rates of related hospitalizations after the date of screening (from 0.14% to 0.31%; P.001).In an analysis of data from the PCSP, we found high-quality evidence that colonoscopy as a screening intervention does not increase mortality before or after colonoscopy. However, it may be associated with a small but significant increase in unplanned hospitalizations, especially after the colonoscopy is completed.
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- 2019
43. Statement of the expert group on the current practice and prospects for the treatment of complex perirectal fistulas in the course of Crohn's disease
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Agnieszka Dobrowolska, Piotr Eder, Tomasz Banasiewicz, Grażyna Rydzewska, Grzegorz Wallner, Jaroslaw Regula, and Marek Durlik
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Anal fistula ,Adult ,Male ,medicine.medical_specialty ,Disease ,Stoma ,03 medical and health sciences ,0302 clinical medicine ,Pharmacotherapy ,Crohn Disease ,medicine ,Adalimumab ,Humans ,Rectal Fistula ,Digestive System Surgical Procedures ,Aged ,Aged, 80 and over ,Crohn's disease ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,Infliximab ,Surgery ,030220 oncology & carcinogenesis ,Practice Guidelines as Topic ,Drainage ,030211 gastroenterology & hepatology ,Female ,Steroids ,business ,Ligation ,medicine.drug - Abstract
Perirectal fistulas in the course of Crohn’s disease (ChL-C) constitute an important problem in this group of patients. They are observed in a vast majority of patients with involvement through colorectal inflammation. Perirectal fistulas in ChL-C present a great diagnostic and therapeutic challenge due to the intensified clinical symptoms and worse prognosis than in the case of crypt originating fistulas. The condition for implementation of effective treatment of perirectal fistulas in the course of CHL-C is correct diagnosis, defining the anatomy of fistulas, presence of potential stenoses and inflammation in the gastrointestinal tract. Treatment of these fistulas is difficult and requires close cooperation between the colorectal surgeon and the gastroenterologist. The combination of surgical and pharmacological treatment has higher efficacy compared to surgical treatment or pharmacotherapy alone. In conservative treatment, aminosalicylates and steroids are of minor importance, while chemotherapeutics, antibiotics, and thiopurines find application in daily clinical practice. TNF-α neutralizing antibodies such as infliximab (IFX), adalimumab (ADA) or certolizumab (CER) prove to be the most effective. Surgical treatment may be provided as ad hoc; in this case drainage procedures are recommended, usually with leaving a loose seton. Planned procedures consist in the excision of fistulas (simple fistulas) or performing more complex procedures, such as advancement flaps or ligation of the intersphincteric fistula tract Surgical measures can be complemented by the use of video technology (video-assisted anal fistula treatment VAAFT) or vacuum therapy. In extreme cases, it may be necessary to exteriorize the stoma. Treatment of perirectal fistulas includes adhesives or so-called plugs. High hopes may be associated with the introduction of stem cells into clinical practice, which is the administration of non-hematopoietic multipotent cells to the fistulas to induce the phenomenon of immunomodulation and tissue healing.
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- 2019
44. COLORECTAL CANCERS DETECTED FOLLOWING SURGERY AT ANASTOMOSES OR OTHER COLORECTAL LOCATIONS DURING COLONOSCOPY SURVEILLANCE: A SYSTEMATIC REVIEW AND META-ANALYSIS
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Mário Dinis-Ribeiro, E. Dekker, Franco Bazzoli, L Correale, Cesare Hassan, Lorenzo Fuccio, Carlo Senore, Franco Radaelli, Pradeep Bhandari, R. Jover, Thomas Seufferlein, P. Sharma, Jaroslaw Regula, Maria Pellise, A. Repici, Thomas Rösch, J. A. van Hooft, Thierry Ponchon, Diogo Libanio, Sergio Alfieri, Leonardo Frazzoni, and DK Rex
- Subjects
medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,General surgery ,Meta-analysis ,medicine ,Colonoscopy ,Anastomosis ,business - Published
- 2019
45. Endoscopic surveillance after surgical or endoscopic resection for colorectal cancer: European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Digestive Oncology (ESDO) Guideline
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M. rio Dinis-Ribeiro, Jaroslaw Regula, Sergio Alfieri, Catarina Brandão, Jeanin E. van Hooft, Thomas Seufferlein, Cesare Hassan, Eric Van Cutsem, Carlo Senore, Leonardo Frazzoni, Lorenzo Fuccio, Ian M. Gralnek, Evelien Dekker, Jean-Marc Dumonceau, Cristiano Spada, Piotr Tomasz Wysocki, Gerardo Rosati, Rodrigo Jover, Maria Pellise, Thierry Ponchon, Hassan, Cesare, Wysocki, Piotr Tomasz, Fuccio, Lorenzo, Seufferlein, Thoma, Dinis-Ribeiro, Mário, Brandão, Catarina, Regula, Jaroslaw, Frazzoni, Leonardo, Pellise, Maria, Alfieri, Sergio, Dekker, Evelien, Jover, Rodrigo, Rosati, Gerardo, Senore, Carlo, Spada, Cristiano, Gralnek, Ian, Dumonceau, Jean-Marc, van Hooft, Jeanin E, van Cutsem, Eric, and Ponchon, Thierry
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medicine.medical_specialty ,Endoscopic Mucosal Resection ,Colorectal cancer ,MEDLINE ,Colonoscopy ,colorectal cancer ,Endoscopic mucosal resection ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Humans ,Endoscopic resection ,endoscopy ,Gastrointestinal endoscopy ,medicine.diagnostic_test ,business.industry ,General surgery ,Gastroenterology ,Guideline ,Perioperative ,medicine.disease ,Endoscopy ,Europe ,030220 oncology & carcinogenesis ,Population Surveillance ,oncology ,surveillance ,030211 gastroenterology & hepatology ,business ,Colorectal Neoplasms - Abstract
Main Recommendations 1 We recommend post-surgery endoscopic surveillance for CRC patients after intent-to-cure surgery and appropriate oncological treatment for both local and distant disease.Strong recommendation, low quality evidence. 2 We recommend a high quality perioperative colonoscopy before surgery for CRC or within 6 months following surgery.Strong recommendation, low quality evidence. 3 We recommend performing surveillance colonoscopy 1 year after CRC surgery.Strong recommendation, moderate quality evidence. 4 We do not recommend an intensive endoscopic surveillance strategy, e. g. annual colonoscopy, because of a lack of proven benefit.Strong recommendation, moderate quality evidence. 5 After the first surveillance colonoscopy following CRC surgery, we suggest the second colonoscopy should be performed 3 years later, and the third 5 years after the second. If additional high risk neoplastic lesions are detected, subsequent surveillance examinations at shorter intervals may be considered.Weak recommendation, low quality evidence. 6 After the initial surveillance colonoscopy, we suggest halting post-surgery endoscopic surveillance at the age of 80 years, or earlier if life-expectancy is thought to be limited by comorbidities.Weak recommendation, low quality evidence. 7 In patients with a low risk pT1 CRC treated by endoscopy with an R0 resection, we suggest the same endoscopic surveillance schedule as for any CRC.Weak recommendation, low quality evidence.
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- 2019
46. Colorectal Cancer Incidence and Mortality After Removal of Adenomas During Screening Colonoscopies
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Joanna Didkowska, Maria Rupinska, Urszula Wojciechowska, Bartlomiej R. Kocot, Paulina Wieszczy, Maciej Rupinski, Øyvind Holme, Jarek Kobiela, Robert Franczyk, Jaroslaw Regula, Michael Bretthauer, Michal F. Kaminski, Magnus Løberg, Mette Kalager, and David F. Ransohoff
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0301 basic medicine ,Adenoma ,Adult ,Male ,medicine.medical_specialty ,Colorectal cancer ,Population ,Gastroenterology ,Risk Assessment ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Internal medicine ,medicine ,Humans ,Mass Screening ,Mortality ,education ,Early Detection of Cancer ,Aged ,Proportional Hazards Models ,education.field_of_study ,Hepatology ,business.industry ,Incidence (epidemiology) ,Incidence ,Hazard ratio ,Absolute risk reduction ,Colonoscopy ,Middle Aged ,medicine.disease ,030104 developmental biology ,Standardized mortality ratio ,Dysplasia ,Practice Guidelines as Topic ,030211 gastroenterology & hepatology ,Female ,Poland ,business ,Colorectal Neoplasms ,Follow-Up Studies - Abstract
Background & Aims Recommendation of surveillance colonoscopy should be based on risk of colorectal cancer and death after adenoma removal. We aimed to develop a risk classification system based on colorectal cancer incidence and mortality following adenoma removal. Methods We performed a multicenter population-based cohort study of 236,089 individuals (median patient age, 56 years; 37.8% male) undergoing screening colonoscopies with adequate bowel cleansing and cecum intubation at 132 centers in the Polish National Colorectal Cancer Screening Program, from 2000 through 2011. Subjects were followed for a median 7.1 years and information was collected on colorectal cancer development and death. We used recursive partitioning and multivariable Cox models to identify associations between colorectal cancer risk and patient and adenoma characteristics (diameter, growth pattern, grade of dysplasia, and number of adenomas). We developed a risk classification system based on standardized incidence ratios, using data from the Polish population for comparison. The primary endpoints were colorectal cancer incidence and colorectal cancer death. Results We identified 130 colorectal cancers in individuals who had adenomas removed at screening (46.5 per 100,000 person-years) vs 309 in individuals without adenomas (22.2 per 100,000 person-years). Compared with individuals without adenomas, adenomas ≥20 mm in diameter and high-grade dysplasia were associated with increased risk of colorectal cancer (adjusted hazard ratios 9.25; 95% confidence interval [CI] 6.39–13.39, and 3.58; 95% CI 1.96–6.54, respectively). Compared with the general population, colorectal cancer risk was higher or comparable only for individuals with adenomas ≥20 mm in diameter (standardized incidence ratio [SIR] 2.07; 95% CI 1.40–2.93) or with high-grade dysplasia (SIR 0.79; 95% CI 0.39–1.41), whereas for individuals with other adenoma characteristics the risk was lower (SIR 0.35; 95% CI 0.28–0.44). We developed a high-risk classification based on adenoma size ≥20 mm or high-grade dysplasia (instead of the current high-risk classification cutoff of ≥3 adenomas or any adenoma with villous growth pattern, high-grade dysplasia, or ≥10 mm in diameter). Our classification system would reduce the number of individuals classified as high-risk and requiring intensive surveillance from 15,242 (36.5%) to 3980 (9.5%), without increasing risk of colorectal cancer in patients with adenomas (risk difference per 100,000 person-years, 5.6; 95% CI –10.7 to 22.0). Conclusions Using data from the Polish National Colorectal Cancer Screening Program, we developed a risk classification system that would reduce the number of individuals classified as high risk and require intensive surveillance more than 3-fold, without increasing risk of colorectal cancer in patients with adenomas. This system could optimize the use of surveillance colonoscopy.
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- 2019
47. Critical Issues on Diverticular Disease
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Marcello Picchio, Jaroslaw Regula, Marjorie M. Walker, Dan L. Dumitrascu, Adi Lahat, Neil Stollman, and Sebastiano Biondo
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medicine.medical_specialty ,Colorectal cancer ,Colonoscopy ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Càncer colorectal ,Internal medicine ,Ambulatory Care ,Diverticulosis, Colonic ,medicine ,Humans ,Risk factor ,Diverticulitis ,Diverticular Diseases ,First episode ,medicine.diagnostic_test ,business.industry ,Gastroenterology ,Cancer ,Colonoscòpia ,medicine.disease ,Colitis ,digestive system diseases ,Diverticulosis ,030220 oncology & carcinogenesis ,Diverticular disease ,030211 gastroenterology & hepatology ,Colorectal Neoplasms ,business ,Delivery of Health Care - Abstract
In this session diverse critical issues in diverticular disease were considered, including “In or outpatient management of uncomplicated diverticulitis?”, “Segmental colitis associated with diverticulosis: what is it?”and “Diverticular inflammation is a risk factor for colorectal cancer?”. The conclusions drawn are outlined in the statements but in summary, outpatient management is safe in selected patients, as long as correct diagnosis and stage are assured, and this can allow a cost effective treatment. Non-antibiotic management is also safe but should be confined as an outpatient treatment in carefully selected patients. Segmental colitis associated with diverticulosis (SCAD) is a defined pathological entity (only diagnosed on biopsy) characterized by an inflammatory bowel disease-like pathology, occurring principally in the sigmoid colon, with rectal and right colon sparing. The pathogenesis is unclear but may include a genetic predisposition, microbiome alteration and ischaemia. Treatment can last months, and depends on severity, options include antibiotics, 5 ASA and probiotics for mild cases. Severe disease needs systemic steroids or even anti TNFα treatment. Whether diverticular inflammation is a risk factor for colorectal cancer was debated and the conclusion that within the first eighteen months of diagnosis of diverticular disease associations with cancer are found, likely due to similar symptoms and misclassification of disease. After that time, diverticular disease does not increase the risk of colorectal cancer. Therefore, this is recommended to exclude cancer with imaging and colonoscopy after healing of the first episode of diverticulitis.
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- 2019
48. Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn’s Disease After Ileocolonic Resection
- Author
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Silvio Danese, V. Yajnik, P. Gionchetti, Brian G. Feagan, Richard N. Fedorak, O. Dewit, D. Sorrentino, V. F. Annese, W J Sandborn, Michael Chiorean, G. Radford-Smith, S Plevy, I. Lawrance, Jane E. Onken, Simon Campbell, Jewel Johanns, Peter L. Lakatos, G R D’Haens, Denis Franchimont, J. C. Preiss, Giovanni Terrosu, Áron Vincze, Torsten Kucharzik, Charles Randall, I. Stein, Edward V. Loftus, L. Sauberman, X. Li, I. Oikonomou, Frank Zerbib, H. G. Lamprecht, R. Kottoor, J. Vecchio, Severine Vermeire, Daniel Rachmilewitz, J. R. Lachance, J.L. Dupas, W. H. Holderman, Michael Safdi, T. Haas, J.-F. Colombel, Richard B. Gearry, Russell S. Walmsley, R. P. Phillips, Miguel Regueiro, A. B. Hawthorne, David T. Rubin, J. W. Hamilton, G. D'Haens, M Parkes, Jean-Marie Reimund, Fabrizio Bossa, Walter Reinisch, K. A. Peterson, M. Ropeleski, S. Fishman, Marc Chevrier, Hans H Herfarth, Stephen B. Hanauer, Timothy H. Florin, Walter Fries, D. J. Hetzel, D. E. Elliott, János Banai, B. W. Behm, S. Sedghi, Remo Panaccione, Peter D.R. Higgins, Jean-Paul Achkar, Ziad Younes, Raja Atreya, Harald Vogelsang, M. Noar, S. S. Dhalla, U. Boecker, Raymond Bourdages, Ellen Scherl, Eran Goldin, T. Ritter, S. Gassner, Stefanie Howaldt, M. Ricci, Paolo Gionchetti, B. I. Leman, Marion Blank, D. Grunkmeier, Livia Biancone, J. Mudter, N. Chiba, Paolo Usai, R. Hardi, I. P. Beales, István Altorjay, W. J S Devilliers, J. Hill, Daniel C. Baumgart, Jason M. Swoger, Charles A. Sninsky, B. Singh Salh, L. D. Wruble, G. Bramkamp, Dario Sorrentino, Paul Rutgeerts, Stephen J. Bickston, S. Schreiber, D. J. Helper, Eric Lerebours, Jaroslaw Regula, M. D. Kreines, M. Strasser, C. Antoni, Giovanni Maconi, Freddy Cornillie, Laurent Peyrin-Biroulet, J. S. Hanson, Ewa Małecka-Panas, David Rowbotham, Jean-Charles Grimaud, Gerald Fraser, Ursula Seidler, C. Bünning, C. Berg, G. Reicht, Martin Lukas, John W. Popp, Edouard Louis, D. Laharie, Xavier Hébuterne, K. J. Brown, Márta Varga, L. Paradowski, Robert Ehehalt, Sandro Ardizzone, Stephanie Viennot, S. B. Hanauer, Charles N. Bernstein, Milan Lukas, H. Debinski, R. P. Schwarz, Simon Travis, D. I. Weinberg, D. Wallace, R. S. Stubbs, Bin Zou, A. Sloss, John Wyeth, Irit Avni-Biron, Peter Bossuyt, Ira Shafran, Matthieu Allez, Pierre Desreumaux, Michael Schultz, W. Reinisch, William J. Sandborn, APH - Amsterdam Public Health, 10 Public Health & Methodologie, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology, AII - Amsterdam institute for Infection and Immunity, Intensive Care Medicine, UCL - SSS/IREC-Institut de recherche expérimentale et clinique, UCL - SSS/IREC/GAEN-Pôle d'Hépato-gastro-entérologie, UCL - (SLuc) Service de gastro-entérologie, Regueiro, M, Feagan, Bg, Zou, B, Johanns, J, Blank, Ma, Chevrier, M, Plevy, S, Popp, J, Cornillie, Fj, Lukas, M, Danese, S, Gionchetti, P, Hanauer, Sb, Reinisch, W, Sandborn, Wj, Sorrentino, D, Rutgeerts, P, Regueiro, Miguel, Feagan, Brian G., Zou, Bin, Johanns, Jewel, Blank, Marion A., Chevrier, Marc, Plevy, Scott, Popp, John, Cornillie, Freddy J., Lukas, Milan, Danese, Silvio, Gionchetti, Paolo, Hanauer, Stephen B., Reinisch, Walter, Sandborn, William J., Sorrentino, Dario, Rutgeerts, Paul, Debinski, H., Florin, T., Hetzel, D., Lawrance, I., Radford Smith, G., Sloss, A., Sorrentino, D., Gassner, S., Haas, T., Reicht, G., Reinisch, W., Strasser, M., Vogelsang, H., Bossuyt, P., Dewit, O., D'Haens, G., Franchimont, D., Louis, E., Vermeire, S., Bernstein, C. N., Bourdages, R., Chiba, N., Dhalla, S. S., Feagan, B. G., Fedorak, R. N., Lachance, J. R., Panaccione, R., Ropeleski, M., Singh Salh, B., Lukas, M., Colombel, J. F., Allez, M., Desreumaux, P., Dupas, J. L., Grimaud, J. C., Hebuterne, X., Laharie, D., Lerebours, E., Peyrin Biroulet, L., Reimund, J. M., Viennot, S., Zerbib, F., Antoni, C., Atreya, R., Baumgart, D. C., Berg, C., Boecker, U., Bramkamp, G., Bünning, C., Ehehalt, R., Howaldt, S., Kucharzik, T., Lamprecht, H. G., Mudter, J., Preiss, J. C., Schreiber, S., Seidler, U., Altorjay, I., Banai, J., Lakatos, P. L., Varga, M., Vincze, A., Avni Biron, I., Fishman, S., Fraser, G. M., Goldin, E., Rachmilewitz, D., Annese, V., Ardizzone, S., Biancone, L., Bossa, F., Danese, S., Fries, W., Gionchetti, P., Maconi, G., Terrosu, G., Usai, P., D'Haens, G. R., Gearry, R. B., Hill, J., Rowbotham, D. S., Schultz, M., Stubbs, R. S., Wallace, D., Walmsley, R. S., Wyeth, J., Malecka Panas, E., Paradowski, L., Regula, J., Beales, I. P., Campbell, S., Hawthorne, A. B., Parkes, M., Travis, S. P., Achkar, J. P., Behm, B. W., Bickston, S. J., Brown, K. J., Chiorean, M. V., Devilliers, W. J. S., Elliott, D. E., Grunkmeier, D., Hamilton, J. W., Hanauer, S. B., Hanson, J. S., Hardi, R., Helper, D. J., Herfarth, H., Higgins, P. D. R., Holderman, W. H., Kottoor, R., Kreines, M. D., Leman, B. I., Li, X., Loftus, E. V., Noar, M., Oikonomou, I., Onken, J., Peterson, K. A., Phillips, R. P., Randall, C. W., Ricci, M., Ritter, T., Rubin, D. T., Safdi, M., Sandborn, W. J., Sauberman, L., Scherl, E., Schwarz, R. P., Sedghi, S., Shafran, I., Sninsky, C. A., Stein, I., Swoger, J., Vecchio, J., Weinberg, D. I., Wruble, L. D., Yajnik, V., and Younes, Z.
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Adult ,Male ,musculoskeletal diseases ,medicine.medical_specialty ,Colon ,medicine.medical_treatment ,Colonoscopy ,Klinikai orvostudományok ,Placebo ,law.invention ,Anti-TNF ,03 medical and health sciences ,0302 clinical medicine ,Crohn Disease ,Double-Blind Method ,Gastrointestinal Agents ,Randomized controlled trial ,Ileum ,Recurrence ,law ,CDAI ,Inflammatory Bowel Disease ,PREVENT ,Gastroenterology ,Secondary Prevention ,medicine ,Clinical endpoint ,Humans ,Postoperative Period ,Colectomy ,Gastrointestinal agent ,Hepatology ,medicine.diagnostic_test ,business.industry ,Orvostudományok ,Middle Aged ,Crohn's Disease Activity Index ,Infliximab ,Surgery ,Treatment Outcome ,030220 oncology & carcinogenesis ,Female ,030211 gastroenterology & hepatology ,business ,medicine.drug - Abstract
Background & Aims Most patients with Crohn's disease (CD) eventually require an intestinal resection. However, CD frequently recurs after resection. We performed a randomized trial to compare the ability of infliximab vs placebo to prevent CD recurrence. Methods We evaluated the efficacy of infliximab in preventing postoperative recurrence of CD in 297 patients at 104 sites worldwide from November 2010 through May 2012. All study patients had undergone ileocolonic resection within 45 days before randomization. Patients were randomly assigned (1:1) to groups given infliximab (5 mg/kg) or placebo every 8 weeks for 200 weeks. The primary end point was clinical recurrence, defined as a composite outcome consisting of a CD Activity Index score >200 and a ≥70-point increase from baseline, and endoscopic recurrence (Rutgeerts score ≥i2, determined by a central reader) or development of a new or re-draining fistula or abscess, before or at week 76. Endoscopic recurrence was a major secondary end point. Results A smaller proportion of patients in the infliximab group had a clinical recurrence before or at week 76 compared with the placebo group, but this difference was not statistically significant (12.9% vs 20.0%; absolute risk reduction [ARR] with infliximab, 7.1%; 95% confidence interval: -1.3% to 15.5%; P =.097). A significantly smaller proportion of patients in the infliximab group had endoscopic recurrence compared with the placebo group (30.6% vs 60.0%; ARR with infliximab, 29.4%; 95% confidence interval: 18.6% to 40.2%; P
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- 2016
49. Reinvitation to screening colonoscopy
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Maciej Rupinski, Malgorzata Pisera, Ewa Kraszewska, Michal F. Kaminski, and Jaroslaw Regula
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Male ,Health Knowledge, Attitudes, Practice ,medicine.medical_specialty ,Time Factors ,Population ,Colonoscopy ,Screening colonoscopy ,law.invention ,Appointments and Schedules ,03 medical and health sciences ,0302 clinical medicine ,Patient Education as Topic ,Randomized controlled trial ,law ,medicine ,Humans ,Mass Screening ,030212 general & internal medicine ,education ,Early Detection of Cancer ,Mass screening ,Response rate (survey) ,education.field_of_study ,Hepatology ,medicine.diagnostic_test ,business.industry ,Gastroenterology ,Attendance ,Middle Aged ,Patient Acceptance of Health Care ,Correspondence as Topic ,Family medicine ,Female ,030211 gastroenterology & hepatology ,Poland ,Colorectal Neoplasms ,business ,Primary screening - Abstract
The response rate to initial invitation to population-based primary screening colonoscopy within the NordICC trial (NCT 00883792) in Poland is around 50%. The aim of this study was to compare the effect of a reinvitation letter and invitation to an educational intervention on participation in screening colonoscopy in nonresponders to initial invitation.Within the NordICC trial framework, individuals living in the region of Warsaw, who were drawn from Population Registries and assigned randomly to the screening group, received an invitation letter and a reminder with a prespecified screening colonoscopy appointment date. One thousand individuals, aged 55 to 64 years, who did not respond to both the invitation and the reminding letter were assigned randomly in a 1:1 ratio to the reinvitation group (REI) and the educational meeting group (MEET). The REI group was sent a reinvitation letter and reminder 6 and 3 weeks before the new colonoscopy appointment date, respectively. The MEET group was sent an invitation 6 weeks before an educational meeting date. Outcome measures were participation in screening colonoscopy within 6 months and response rate within 3 months from the date of reinvitation or invitation to an educational meeting.The response rate and the participation rate in colonoscopy were statistically significantly higher in the REI group compared with the MEET group (16.5 vs. 4.3%; P0.001 and 5.2 vs. 2.1%; P=0.008, respectively).A simple reinvitation letter results in a higher response rate and participation rate to screening colonoscopy than invitation to tailored educational meeting in nonresponders to previous invitations. (NCT01183156).
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- 2016
50. Rationale and design of the European Polyp Surveillance (EPoS) trials
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Magnus Løberg, David F. Ransohoff, Michal F. Kaminski, Mário Dinis-Ribeiro, Rodrigo Jover, Michael Bretthauer, Carlo Senore, Øyvind Holme, Antoni Castells, Ann G Zauber, Enrique Quintero, Mette Kalager, Eleanor McFadden, Annike Sunde, Louise Emilsson, Hans-Olov Adami, Miguel A. Hernán, Iris Lansdorp-Vogelaar, Maria Pellise, Jaroslaw Regula, Evelien Dekker, Geir Hoff, Public Health, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA -Cancer Center Amsterdam, and Gastroenterology and Hepatology
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Adenoma ,Adult ,Research design ,medicine.medical_specialty ,Time Factors ,Colorectal cancer ,Colonic Polyps ,Colonoscopy ,Article ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,SDG 3 - Good Health and Well-being ,law ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,030212 general & internal medicine ,Aged ,Splenic flexure ,medicine.diagnostic_test ,business.industry ,Incidence ,Gastroenterology ,Neoplasms, Second Primary ,Middle Aged ,medicine.disease ,digestive system diseases ,Tumor Burden ,Surgery ,Research Design ,Population Surveillance ,030211 gastroenterology & hepatology ,Observational study ,Colorectal Neoplasms ,business - Abstract
Background: Current guidelines recommend surveillance colonoscopies after polyp removal depending on the number and characteristics of polyps, but there is a lack of evidence supporting the recommendations. This report outlines the rationale and design of two randomized trials and one observational study investigating evidence-based surveillance strategies following polyp removal. Study design and endpoints: The EPoS studies started to recruit patients in April 2015. EPoS study I randomizes 13 746 patients with low-risk adenomas (1-2 tubular adenomas size = 10mm in diameter, or adenoma with high-grade dysplasia, or >25% villous features) to surveillance after 3, 5, and 10 years, or 5 and 10 years only. EPoS study III offers surveillance after 5 and 10 years to patients with serrated polyps >= 10mm in diameter at any location, or serrated polyps >= 5mm in diameter proximal to the splenic flexure. All polyps are removed before patients enter the trials. The primary end point is colorectal cancer incidence after 10 years. We assume a colorectal cancer risk of 1% for patients in EPoS I, and 2% for patients in EPoS II. Using a noninferiority hypothesis with an equivalence interval of 0.5% for EPoS I and 0.7% for EPoS II, the trials are 90% powered to uncover differences larger than the equivalence intervals. For EPoS III, no power analyses have been performed. Conclusions: The present trials aim to develop evidence-based strategies for polyp surveillance, thereby maximizing effectiveness and minimizing resources.
- Published
- 2016
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