113 results on '"Early DS"'
Search Results
2. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos)
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Waye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, and Rex DK
- Abstract
BACKGROUND: Colonoscopy may fail to detect neoplasia located on the proximal sides of haustral folds and flexures. The Third Eye Retroscope (TER) provides a simultaneous retrograde view that complements the forward view of a standard colonoscope. OBJECTIVE: To evaluate the added benefit for polyp detection during colonoscopy of a retrograde-viewing device. DESIGN: Open-label, prospective, multicenter study evaluating colonoscopy by using a TER in combination with a standard colonoscope. SETTING: Eight U.S. sites, including university medical centers, ambulatory surgery centers, a community hospital, and a physician's office. PATIENTS: A total of 249 patients (age range 55-80 years) presenting for screening or surveillance colonoscopy. INTERVENTIONS: After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. MAIN OUTCOME MEASUREMENTS: The number and sizes of lesions (adenomas and all polyps) detected with the standard colonoscope and the number and sizes of lesions found only because they were first detected with the TER. RESULTS: In the 249 subjects, 257 polyps (including 136 adenomas) were identified with the colonoscope alone. The TER allowed detection of 34 additional polyps (a 13.2% increase; P < .0001) including 15 additional adenomas (an 11.0% increase; P < .0001). For lesions 6 mm or larger, the additional detection rates with the TER for all polyps and for adenomas were 18.2% and 25.0%, respectively. For lesions 10 mm or larger, the additional detection rates with the TER for all polyps and for adenomas were 30.8% and 33.3%, respectively. In 28 (11.2%) individuals, at least 1 additional polyp was found with the TER. In 8 (3.2%) patients, the polyp detected with the TER was the only one found. Every polyp that was detected with the TER was subsequently located with the colonoscope and removed. For all polyps and for adenomas, the additional detection rates for the TER were 9.7%/4.1% in the left colon (the splenic flexure to the rectum) and 16.5%/14.9% in the right colon (the cecum to the transverse colon), respectively. LIMITATIONS: There was no randomization or comparison with a separate control group. CONCLUSIONS: A retrograde-viewing device revealed areas that were hidden from the forward-viewing colonoscope and allowed detection of 13.2% additional polyps, including 11.0% additional adenomas. Additional detection rates with the TER for adenomas 6 mm or larger and 10 mm or larger were 25.0% and 33.3%, respectively. (Clinical trial registration number: NCT00657371.). [ABSTRACT FROM AUTHOR]
- Published
- 2010
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3. Patient preference and recall of results of EUS-guided FNA.
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Early DS, Janec E, Azar R, Ristvedt S, Gao F, and Edmundowicz SA
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BACKGROUND: There are no clear guidelines regarding the best way, in terms of timing and setting, to deliver results to patients who undergo EUS-guided FNA (EUS-FNA) of suspected pancreatic masses. OBJECTIVE: We aimed to study (1) whether patients undergoing EUS-FNA prefer to receive preliminary results immediately after the procedure or at a later date, after final results are known; and (2) to assess the accuracy of patients' recollection of information given to them regarding their FNA diagnosis. DESIGN: We enrolled patients presenting to our endoscopy center for EUS-FNA of suspected pancreatic masses and obtained data through 4 pilot surveys. SETTINGS: University-based endoscopy center. PATIENTS: Sixty patients who were referred for EUS-FNA of suspected pancreatic masses. RESULTS: A total of 57 of 59 patients (96.6%) wanted preliminary results the same day as the procedure. Twenty-eight of 60 (42.7%) knew they were having a biopsy, and 42 of 60 (70%) knew cancer was suspected. Of those who received preliminary results, 31 of 41 (75%) remembered the diagnosis correctly the next day, and 32 of 38 (84%) remembered the diagnosis correctly 1 week later. LIMITATIONS: Single-center pilot study. CONCLUSIONS: The majority of our patients wished to receive preliminary results the same day as the procedure. Although most patients remembered results correctly, 25% of patients did not remember the correct diagnosis the next day. Further work is needed to improve patient's understanding of the reasons for the EUS-FNA and recall of preliminary EUS-FNA results. [ABSTRACT FROM AUTHOR]
- Published
- 2006
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4. What to do now to screen for colorectal cancer.
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Early DS, Fletcher R, and Rodney WM
- Abstract
New guidelines urge screening at age 50 in average-risk persons. Your effort is supported by new Medicare reimbursement and the safety and cost-effectiveness of the fecal occult blood test in combination with sigmoidoscopy. [ABSTRACT FROM AUTHOR]
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- 1998
5. NCCN Guidelines® Insights: Colorectal Cancer Screening, Version 1.2024.
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Ness RM, Llor X, Abbass MA, Bishu S, Chen CT, Cooper G, Early DS, Friedman M, Fudman D, Giardiello FM, Glaser K, Gurudu S, Hall M, Huang LC, Issaka R, Katona B, Kidambi T, Lazenby AJ, Maratt J, Markowitz AJ, Marsano J, May FP, Mayer RJ, Olortegui K, Patel S, Peter S, Porter LD, Shafi M, Stanich PP, Terdiman J, Vu P, Weiss JM, Wood E, Cassara CJ, and Sambandam V
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- Humans, Mass Screening methods, Mass Screening standards, Colorectal Neoplasms diagnosis, Early Detection of Cancer standards, Early Detection of Cancer methods
- Abstract
The NCCN Guidelines for Colorectal Cancer (CRC) Screening describe various colorectal screening modalities as well as recommended screening schedules for patients at average or increased risk of developing sporadic CRC. They are intended to aid physicians with clinical decision-making regarding CRC screening for patients without defined genetic syndromes. These NCCN Guidelines Insights focus on select recent updates to the NCCN Guidelines, including a section on primary and secondary CRC prevention, and provide context for the panel's recommendations regarding the age at which to initiate screening in average-risk individuals and those with increased risk based on personal history of childhood, adolescent, and young adult cancer.
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- 2024
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6. High-dimensional deconstruction of pancreatic cancer identifies tumor microenvironmental and developmental stemness features that predict survival.
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Storrs EP, Chati P, Usmani A, Sloan I, Krasnick BA, Babbra R, Harris PK, Sachs CM, Qaium F, Chatterjee D, Wetzel C, Goedegebuure SP, Hollander T, Anthony H, Ponce J, Khaliq AM, Badiyan S, Kim H, Denardo DG, Lang GD, Cosgrove ND, Kushnir VM, Early DS, Masood A, Lim KH, Hawkins WG, Ding L, Fields RC, Das KK, and Chaudhuri AA
- Abstract
Numerous cell states are known to comprise the pancreatic ductal adenocarcinoma (PDAC) tumor microenvironment (TME). However, the developmental stemness and co-occurrence of these cell states remain poorly defined. Here, we performed single-cell RNA sequencing (scRNA-seq) on a cohort of treatment-naive PDAC time-of-diagnosis endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) samples (n = 25). We then combined these samples with surgical resection (n = 6) and publicly available samples to increase statistical power (n = 80). Following annotation into 25 distinct cell states, cells were scored for developmental stemness, and a customized version of the Ecotyper tool was used to identify communities of co-occurring cell states in bulk RNA-seq samples (n = 268). We discovered a tumor microenvironmental community comprised of aggressive basal-like malignant cells, tumor-promoting SPP1+ macrophages, and myofibroblastic cancer-associated fibroblasts associated with especially poor prognosis. We also found a developmental stemness continuum with implications for survival that is present in both malignant cells and cancer-associated fibroblasts (CAFs). We further demonstrated that high-dimensional analyses predictive of survival are feasible using standard-of-care, time-of-diagnosis EUS-FNB specimens. In summary, we identified tumor microenvironmental and developmental stemness characteristics from a high-dimensional gene expression analysis of PDAC using human tissue specimens, including time-of-diagnosis EUS-FNB samples. These reveal new connections between tumor microenvironmental composition, CAF and malignant cell stemness, and patient survival that could lead to better upfront risk stratification and more personalized upfront clinical decision-making., (© 2023. Nature Publishing Group UK.)
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- 2023
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7. Long-term intensive endurance exercise training is associated to reduced markers of cellular senescence in the colon mucosa of older adults.
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Demaria M, Bertozzi B, Veronese N, Spelta F, Cava E, Tosti V, Piccio L, Early DS, and Fontana L
- Abstract
Regular endurance exercise training is an effective intervention for the maintenance of metabolic health and the prevention of many age-associated chronic diseases. Several metabolic and inflammatory factors are involved in the health-promoting effects of exercise training, but regulatory mechanisms remain poorly understood. Cellular senescence-a state of irreversible growth arrest-is considered a basic mechanism of aging. Senescent cells accumulate over time and promote a variety of age-related pathologies from neurodegenerative disorders to cancer. Whether long-term intensive exercise training affect the accumulation of age-associated cellular senescence is still unclear. Here, we show that the classical senescence markers p16 and IL-6 were markedly higher in the colon mucosa of middle-aged and older overweight adults than in young sedentary individuals, but this upregulation was significantly blunted in age-matched endurance runners. Interestingly, we observe a linear correlation between the level of p16 and the triglycerides to HDL ratio, a marker of colon adenoma risk and cardiometabolic dysfunction. Our data suggest that chronic high-volume high-intensity endurance exercise can play a role in preventing the accumulation of senescent cells in cancer-prone tissues like colon mucosa with age. Future studies are warranted to elucidate if other tissues are also affected, and what are the molecular and cellular mechanisms that mediate the senopreventative effects of different forms of exercise training., (© 2023. The Author(s).)
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- 2023
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8. A Guide to Upper Gastrointestinal Tract, Biliary, and Pancreatic Disorders: Clinical Updates in Women's Health Care Primary and Preventive Care Review.
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Abushamma S and Early DS
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Abstract: This monograph provides an overview of pathophysiology and screening, followed by sections on diagnosis and management of upper gastrointestinal, biliary, and pancreatic disorders. The most common upper gastrointestinal disorder is GERD, which affects women of all ages and creates a treatment challenge in pregnant women. Gallstone disease is the most common biliary disorder. A case-based format is used to review management of gallstone disease in pregnancy, as well as chronic pancreatitis in pregnancy. Some of these disorders can be treated by obstetrician-gynecologists; however, many require additional testing and treatment in consultation with a gastroenterologist., (Copyright © 2021 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)
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- 2021
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9. Hemostatic spray powder TC-325 in the primary endoscopic treatment of peptic ulcer-related bleeding: multicenter international registry.
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Hussein M, Alzoubaidi D, Lopez MF, Weaver M, Ortiz-Fernandez-Sordo J, Bassett P, Rey JW, Hayee BH, Despott E, Murino A, Moreea S, Boger P, Dunn J, Mainie I, Graham D, Mullady DK, Early DS, Ragunath K, Anderson JT, Bhandari P, Goetz M, Kiesslich R, Coron E, Lovat LB, and Haidry R
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- France, Germany, Humans, Minerals, Neoplasm Recurrence, Local, Peptic Ulcer Hemorrhage therapy, Powders, Recurrence, Registries, Treatment Outcome, Hemostasis, Endoscopic, Hemostatics, Peptic Ulcer
- Abstract
Background: Upper gastrointestinal bleeding (UGIB) is a leading cause of morbidity and is associated with a 2 % - 17 % mortality rate in the UK and USA. Bleeding peptic ulcers account for 50 % of UGIB cases. Endoscopic intervention in a timely manner can improve outcomes. Hemostatic spray is an endoscopic hemostatic powder for GI bleeding. This multicenter registry was created to collect data prospectively on the immediate endoscopic hemostasis of GI bleeding in patients with peptic ulcer disease when hemostatic spray is applied as endoscopic monotherapy, dual therapy, or rescue therapy., Methods: Data were collected prospectively (January 2016 - March 2019) from 14 centers in the UK, France, Germany, and the USA. The application of hemostatic spray was decided upon at the endoscopist's discretion., Results: 202 patients with UGIB secondary to peptic ulcers were recruited. Immediate hemostasis was achieved in 178/202 patients (88 %), 26/154 (17 %) experienced rebleeding, 21/175 (12 %) died within 7 days, and 38/175 (22 %) died within 30 days (all-cause mortality). Combination therapy of hemostatic spray with other endoscopic modalities had an associated lower 30-day mortality (16 %, P < 0.05) compared with monotherapy or rescue therapy. There were high immediate hemostasis rates across all peptic ulcer disease Forrest classifications., Conclusions: This is the largest case series of outcomes of peptic ulcer bleeding treated with hemostatic spray, with high immediate hemostasis rates for bleeding peptic ulcers., Competing Interests: Dr. Haidry has received educational grants to support research infrastructure from Medtronic Ltd., Cook Endoscopy (fellowship support), Pentax Europe, C2 Therapeutics, Beamline Diagnostic, and Fractyl Ltd. Dr. Hayee has received research grants from Fujifilm EU, Olympus UK, Takeda Pharmaceuticals UK, and AbbVie UK. Dr. Murino is a consultant for Boston Scientific and GI Supply, and has received academic grants from Fujifilm, Aquilant Endoscopy, Norgine, and Olympus. All of the remaining authors declare that they have no conflicts of interest., (Thieme. All rights reserved.)
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- 2021
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10. NCCN Guidelines Insights: Colorectal Cancer Screening, Version 2.2020.
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Provenzale D, Ness RM, Llor X, Weiss JM, Abbadessa B, Cooper G, Early DS, Friedman M, Giardiello FM, Glaser K, Gurudu S, Halverson AL, Issaka R, Jain R, Kanth P, Kidambi T, Lazenby AJ, Maguire L, Markowitz AJ, May FP, Mayer RJ, Mehta S, Patel S, Peter S, Stanich PP, Terdiman J, Keller J, Dwyer MA, and Ogba N
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- Humans, Mass Screening, Colorectal Neoplasms diagnosis, Colorectal Neoplasms epidemiology, Early Detection of Cancer
- Abstract
The NCCN Guidelines for Colorectal Cancer (CRC) Screening describe various colorectal screening modalities as well as recommended screening schedules for patients at average or increased risk of developing sporadic CRC. They are intended to aid physicians with clinical decision-making regarding CRC screening for patients without defined genetic syndromes. These NCCN Guidelines Insights focus on select recent updates to the NCCN Guidelines, including a section on primary and secondary CRC prevention, and provide context for the panel's recommendations regarding the age to initiate screening in average risk individuals and follow-up for low-risk adenomas.
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- 2020
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11. Effect of individualized feedback on learning curves in EGD and colonoscopy: a cluster randomized controlled trial.
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Han S, Obuch JC, Keswani RN, Hall M, Patel SG, Menard-Katcher P, Simon V, Ezekwe E, Aagaard E, Ahmad A, Alghamdi S, Austin K, Brimhall B, Broy C, Carlin L, Cooley M, Di Palma JA, Duloy AM, Early DS, Ellert S, Gaumnitz EA, Goyal J, Kathpalia P, Day L, El-Nachef N, Kerman D, Lee RH, Lunsford T, Mittal M, Morigeau K, Pietrak S, Piper M, Shah AS, Shapiro AB, Shergill A, Sonnier W, Sorrell C, Vignesh S, and Wani S
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- Clinical Competence, Colonoscopy, Feedback, Gastroenterology education, Humans, Learning Curve
- Abstract
Background and Aims: Gastroenterology fellowships need to ensure that trainees achieve competence in upper endoscopy (EGD) and colonoscopy. Because the impact of structured feedback remains unknown in endoscopy training, this study compared the effect of structured feedback with standard feedback on trainee learning curves for EGD and colonoscopy., Methods: In this multicenter, cluster, randomized controlled trial, trainees received either individualized quarterly learning curves or feedback standard to their fellowship. Assessment was performed in all trainees using the Assessment of Competency in Endoscopy tool on 5 consecutive procedures after every 25 EGDs and colonoscopies. Individual learning curves were created using cumulative sum (CUSUM) analysis. The primary outcome was the mean CUSUM score in overall technical and overall cognitive skills., Results: In all, 13 programs including 132 trainees participated. The intervention arm (6 programs, 51 trainees) contributed 558 EGD and 600 colonoscopy assessments. The control arm (7 programs, 81 trainees) provided 305 EGD and 468 colonoscopy assessments. For EGD, the intervention arm (-.7 [standard deviation {SD}, 1.3]) had a superior mean CUSUM score in overall cognitive skills compared with the control arm (1.6 [SD, .8], P = .03) but not in overall technical skills (intervention, -.26 [SD, 1.4]; control, 1.76 [SD, .7]; P = .06). For colonoscopy, no differences were found between the 2 arms in overall cognitive skills (intervention, -.7 [SD, 1.3]; control, .7 [SD, 1.3]; P = .95) or overall technical skills (intervention, .1 [SD, 1.5]; control, -.1 [SD, 1.5]; P = .77)., Conclusions: Quarterly feedback in the form of individualized learning curves did not affect learning curves for EGD and colonoscopy in a clinically meaningful manner. (Clinical trial registration number: NCT02891304.)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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12. A Prospective Multicenter Study Evaluating Endoscopy Competence Among Gastroenterology Trainees in the Era of the Next Accreditation System.
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Han S, Obuch JC, Duloy AM, Keswani RN, Hall M, Simon V, Ezekwe E, Menard-Katcher P, Patel SG, Aagard E, Brimhall B, Ahmad A, Alghamdi S, Brown MD, Broy C, Carlin L, Chugh P, Connolly SE, Cooley DM, Cowley K, Di Palma JA, Early DS, Ellert S, Gaumnitz EA, Ghassemi KA, Lebovics E, Lee RH, Lunsford T, Massaad J, Mittal M, Morigeau K, Pietrak S, Piper M, Shah AS, Shapiro A, Sonnier W, Sorrell C, Vignesh S, Woolard S, and Wani S
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- Accreditation, Clinical Competence, Feasibility Studies, Female, Humans, Learning Curve, Male, Program Evaluation, Prospective Studies, Colonoscopy education, Endoscopy, Digestive System education, Gastroenterology education
- Abstract
Purpose: The Next Accreditation System requires training programs to demonstrate competence among trainees. Within gastroenterology (GI), there are limited data describing learning curves and structured assessment of competence in esophagogastroduodenoscopy (EGD) and colonoscopy. In this study, the authors aimed to demonstrate the feasibility of a centralized feedback system to assess endoscopy learning curves among GI trainees in EGD and colonoscopy., Method: During academic year 2016-2017, the authors performed a prospective multicenter cohort study, inviting participants from multiple GI training programs. Trainee technical and cognitive skills were assessed using a validated competence assessment tool. An integrated, comprehensive data collection and reporting system was created to apply cumulative sum analysis to generate learning curves that were shared with program directors and trainees on a quarterly basis., Results: Out of 183 fellowships invited, 129 trainees from 12 GI fellowships participated, with an overall trainee participation rate of 72.1% (93/129); the highest participation level was among first-year trainees (90.9%; 80/88), and the lowest was among third-year trainees (51.2%; 27/53). In all, 1,385 EGDs and 1,293 colonoscopies were assessed. On aggregate learning curve analysis, third-year trainees achieved competence in overall technical and cognitive skills, while first- and second-year trainees demonstrated the need for ongoing supervision and training in the majority of technical and cognitive skills., Conclusions: This study demonstrated the feasibility of using a centralized feedback system for the evaluation and documentation of trainee performance in EGD and colonoscopy. Furthermore, third-year trainees achieved competence in both endoscopic procedures, validating the effectiveness of current training programs.
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- 2020
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13. NCCN Guidelines Insights: Genetic/Familial High-Risk Assessment: Colorectal, Version 2.2019.
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Gupta S, Provenzale D, Llor X, Halverson AL, Grady W, Chung DC, Haraldsdottir S, Markowitz AJ, Slavin TP Jr, Hampel H, Ness RM, Weiss JM, Ahnen DJ, Chen LM, Cooper G, Early DS, Giardiello FM, Hall MJ, Hamilton SR, Kanth P, Klapman JB, Lazenby AJ, Lynch PM, Mayer RJ, Mikkelson J, Peter S, Regenbogen SE, Dwyer MA, and Ogba N
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- Adenomatous Polyposis Coli diagnosis, Adenomatous Polyposis Coli genetics, Adenomatous Polyposis Coli therapy, Colorectal Neoplasms therapy, Diagnosis, Differential, Humans, Neoplastic Syndromes, Hereditary diagnosis, Neoplastic Syndromes, Hereditary genetics, Neoplastic Syndromes, Hereditary therapy, Risk Assessment, Colorectal Neoplasms diagnosis, Colorectal Neoplasms genetics, Genetic Association Studies, Genetic Predisposition to Disease
- Abstract
Identifying individuals with hereditary syndromes allows for improved cancer surveillance, risk reduction, and optimized management. Establishing criteria for assessment allows for the identification of individuals who are carriers of pathogenic genetic variants. The NCCN Guidelines for Genetic/Familial High-Risk Assessment: Colorectal provide recommendations for the assessment and management of patients with high-risk colorectal cancer syndromes. These NCCN Guidelines Insights focus on criteria for the evaluation of Lynch syndrome and considerations for use of multigene testing in the assessment of hereditary colorectal cancer syndromes.
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- 2019
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14. Anatomic location of Barrett's esophagus recurrence after endoscopic eradication therapy: development of a simplified surveillance biopsy strategy.
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Omar M, Thaker AM, Wani S, Simon V, Ezekwe E, Boniface M, Edmundowicz S, Obuch J, Cinnor B, Brauer BC, Wood M, Early DS, Lang GD, Mullady D, Hollander T, Kushnir V, Komanduri S, and Muthusamy VR
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- Adenocarcinoma diagnosis, Adenocarcinoma surgery, Aged, Barrett Esophagus diagnosis, Barrett Esophagus surgery, Endoscopic Mucosal Resection, Esophageal Neoplasms diagnosis, Esophageal Neoplasms surgery, Esophagoscopy, Female, Humans, Male, Middle Aged, Neoplasm Recurrence, Local diagnosis, Radiofrequency Ablation, Recurrence, Watchful Waiting, Adenocarcinoma pathology, Barrett Esophagus pathology, Biopsy methods, Esophageal Neoplasms pathology, Esophagus pathology, Neoplasm Recurrence, Local pathology
- Abstract
Background and Aims: Surveillance endoscopy is recommended after endoscopic eradication therapy (EET) for Barrett's esophagus (BE) because of the risk of recurrence. Currently recommended biopsy protocols are based on expert opinion and consist of sampling visible lesions followed by random 4-quadrant biopsy sampling throughout the length of the original BE segment. Despite this protocol, some recurrences are not visibly identified. We aimed to identify the anatomic location and histology of recurrences after successful EET with the goal of developing a more efficient and evidence-based surveillance biopsy protocol., Methods: We performed an analysis of a large multicenter database of 443 patients who underwent EET and achieved complete eradication of intestinal metaplasia (CE-IM) from 2005 to 2015. The endoscopic location of recurrence relative to the squamocolumnar junction (SCJ), visible recurrence identified during surveillance endoscopy, and time to recurrence after CE-IM were assessed., Results: Fifty patients with BE recurrence were studied in the final analysis. Seventeen patients (34%) had nonvisible recurrences. In this group, biopsy specimens demonstrating recurrence were taken from within 2 cm of the SCJ in 16 of these 17 patients (94%). Overall, 49 of 50 recurrences (98%) occurred either within 2 cm of the SCJ or at the site of a visible lesion. Late recurrences (>1 year) were more likely to be visible than early (<1 year) recurrences (P = .006)., Conclusions: Recurrence after EET detected by random biopsy sampling is identified predominately in the distal esophagus and occurs earlier than visible recurrences. As such, we suggest a modified biopsy protocol with targeted sampling of visible lesions followed by random biopsy sampling within 2 cm of the SCJ to optimize detection of recurrence after EET. (Clinical trial registration number: NCT02634645.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
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- 2019
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15. Health-related quality of life and long-term outcomes after endoscopic therapy for walled-off pancreatic necrosis.
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Smith ZL, Gregory MH, Elsner J, Alajlan BA, Kodali D, Hollander T, Sayuk GS, Lang GD, Das KK, Mullady DK, Early DS, and Kushnir VM
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- Adult, Aged, Aged, 80 and over, Case-Control Studies, Cross-Sectional Studies, Female, Health Status, Humans, Male, Middle Aged, Pancreatitis, Acute Necrotizing complications, Pancreatitis, Acute Necrotizing mortality, Survival Rate, Time Factors, Treatment Outcome, Young Adult, Drainage, Endoscopy, Pancreatitis, Acute Necrotizing surgery, Quality of Life
- Abstract
Background and Aim: Walled-off pancreatic necrosis (WON) frequently develops after necrotizing pancreatitis. Endoscopic drainage has become the preferred modality for symptomatic or infected WON. The aim of the present study was to assess health-related quality of life (HR-QOL) and long-term outcomes in patients undergoing endoscopic drainage for WON., Methods: Patients undergoing endoscopic drainage of WON from January 2006 to May 2016 were identified. Data recorded included demographic information, and the incidence of long-term sequelae including pancreatic endocrine and exocrine insufficiency. Attempts were made to contact all patients. HR-QOL was assessed using the SF-36 questionnaire., Results: Eighty patients were analyzed, 41 (51.3%) of whom completed the SF-36. One-year all-cause mortality was 6.2%, and disease-related mortality was 3.7%. A notable proportion of patients developed exocrine insufficiency (32.5%), endocrine insufficiency (27.7%), and long-term opiate use (42.5%). Development of exocrine insufficiency was predictive of lower total SF-36 scores (P = 0.016). Patients with WON had better HR-QOL compared with cohorts of irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD). In patients developing exocrine insufficiency versus healthy controls, poorer scores in the physical role (P < 0.001), general health (P < 0.001), vitality (P = 0.001), and emotional role (P = 0.029) domains were observed. Exocrine insufficiency patients had better HR-QOL than the IBS and IBD cohorts, although these differences were less pronounced., Conclusion: After undergoing endoscopic drainage for WON, patients have relatively preserved HR-QOL. The subset of patients that develop exocrine insufficiency have significantly poorer HR-QOL compared to healthy controls, although not to the degree of chronic gastrointestinal disorders such as IBS and IBD., (© 2018 Japan Gastroenterological Endoscopy Society.)
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- 2019
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16. Dysplasia severity is associated with poor quality of life in patients with Barrett's esophagus referred for endoscopic eradication therapy.
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Han S, Yadlapati R, Simon V, Ezekwe E, Early DS, Kushnir V, Hollander T, Brauer BC, Hammad H, Edmundowicz SA, Wood M, Shaheen NJ, Muthusamy RV, Komanduri S, and Wani S
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- Aged, Esophagoscopy psychology, Female, Humans, Hyperplasia, Logistic Models, Male, Middle Aged, Multivariate Analysis, Patient Reported Outcome Measures, Prospective Studies, Referral and Consultation, Barrett Esophagus pathology, Barrett Esophagus psychology, Esophagus pathology, Quality of Life, Severity of Illness Index
- Abstract
Limited data exist regarding patient-reported outcomes and quality of life (QOL) experienced by patients with Barrett's esophagus (BE) referred for endoscopic eradication therapy (EET). Specifically, the impact of grade of dysplasia has not been explored. The purpose of this study is to measure patient-reported symptoms and QOL and identify factors associated with poor QOL in BE patients referred for EET. This was a prospective multicenter study conducted from January 2015 to October 2017, which included patients with BE referred for EET. Participants completed a set of validated questionnaires to measure QOL, symptom severity, and psychosocial factors. The primary outcome was poor QOL defined by a PROMIS score >12. Multivariable logistic regression analysis was performed to identify factors associated with poor QOL. In total, 193 patients participated (mean age 64.6 years, BE length 5.5 cm, 82% males, 92% Caucasians) with poor QOL reported in 104 (53.9%) participants. On univariate analysis, patients with poor QOL had lower use of twice daily proton pump inhibitor use (61.5% vs. 86.5%, P = 0.03), shorter disease duration (4.9 vs. 5.9 years, P = 0.04) and progressive increase in grade of dysplasia (high-grade dysplasia: 68.8% vs. 31.3%, esophageal adenocarcinoma: 75.5% vs. 24.5%, P < 0.001). Multivariate analysis demonstrated that high-grade dysplasia was independently associated with poor QOL (OR: 5.57, 95% CI: 1.05, 29.5, P = 0.04). In summary, poor QOL is experienced by the majority of patients with BE referred for EET and the degree of dysplasia was independently associated with poor QOL, which emphasizes the need to incorporate patient-centered outcomes when studying treatment of BE-related dysplasia.
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- 2019
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17. The importance of early recognition in management of ERCP-related perforations.
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Bill JG, Smith Z, Brancheck J, Elsner J, Hobbs P, Lang GD, Early DS, Das K, Hollander T, Doyle MBM, Fields RC, Hawkins WG, Strasberg SM, Hammill C, Chapman WC, Edmundowicz S, Mullady DK, and Kushnir VM
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- Drainage, Female, Humans, Intensive Care Units, Intestinal Perforation classification, Intestinal Perforation etiology, Intestinal Perforation therapy, Length of Stay statistics & numerical data, Male, Middle Aged, Patient Admission statistics & numerical data, Retrospective Studies, Systemic Inflammatory Response Syndrome etiology, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Delayed Diagnosis, Intestinal Perforation diagnosis
- Abstract
Background: Iatrogenic perforations related to endoscopic retrograde cholangiopancreatography (ERCP) are rare events, carrying with it a mortality of up to 8%. Given the rarity of this adverse event, there remains limited data and continued uncertainties when choosing therapeutic strategies. Our aims were to evaluate the management of ERCP-related perforations and compare outcomes based on timing of recognition., Methods: The endoscopic databases of two tertiary care centers were interrogated to identify consecutive adult patients who sustained ERCP-related perforation over a 10-year period from 2006 to 2016. Electronic medical records were reviewed to extract demographic data, perforation type, management strategies, clinical data, and patient outcomes., Results: 14,045 ERCP's were performed during our 10-year study period. Sixty-three patients (average age 62.3 ± 2.38 years, 76% female) with ERCP-related perforations were included. Stapfer I perforations were found in 14 (22.2%) patients, Stapfer II in 24 (38.1%), and Stapfer III and IV perforations were identified in 16 (25.4%) and 9 (14.28%), respectively. Forty-seven (74.6%) perforations were recognized immediately during the ERCP, whereas 16 (25.4%) were recognized late. Endoscopic therapy was attempted in 35 patients in whom perforations were identified immediately, and was technically successful in 33 (94.3%). In all, 4 (1 immediate/ 3 delayed) patients required percutaneous drainage and 9 (5 immediate/ 4 delayed) surgery. Length of hospital stay, ICU admission were significantly shorter and incidence of SIRS was significantly lower when perforation was recognized immediately., Conclusions: Immediate recognition of ERCP-related perforations leads to more favorable patient outcomes; with lower incidence of SIRS, less need for ICU level care, and shorter hospital stay.
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- 2018
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18. Utility of Endoscopic Ultrasound in Evaluating Local Recurrence After Surgery for Pancreatic Cancer.
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Lang GD, Mullady DK, Early DS, Hollander T, Edmundowicz SA, Murad FM, Strasberg SM, Fields RC, Hawkins WG, Doyle MB, Chapman WC, Wang-Gillam A, and Kushnir VM
- Subjects
- Humans, Prospective Studies, Recurrence, Adenocarcinoma diagnosis, Adenocarcinoma surgery, Diagnostic Tests, Routine methods, Endoscopic Ultrasound-Guided Fine Needle Aspiration methods, Pancreatic Neoplasms diagnosis, Pancreatic Neoplasms surgery
- Abstract
Pancreatic adenocarcinoma recurrence after surgery (PARaS) is associated with poor outcomes. PARaS is locoregional in 50%-80%, effecting the resection bed and adjacent lymphatics.
1-3 Detection of PARaS via endoscopic ultrasound (EUS) is challenging because recurrent malignancy is difficult to distinguish from normal postoperative changes. Diagnosing PARaS is important, because salvage chemotherapy/radiation improves survival.4,5 The purpose of this investigation is to determine the clinical utility of EUS fine-needle aspiration (FNA) in patients with suspected PARaS., (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)- Published
- 2018
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19. NCCN Guidelines Insights: Colorectal Cancer Screening, Version 1.2018.
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Provenzale D, Gupta S, Ahnen DJ, Markowitz AJ, Chung DC, Mayer RJ, Regenbogen SE, Blanco AM, Bray T, Cooper G, Early DS, Ford JM, Giardiello FM, Grady W, Hall MJ, Halverson AL, Hamilton SR, Hampel H, Klapman JB, Larson DW, Lazenby AJ, Llor X, Lynch PM, Mikkelson J, Ness RM, Slavin TP, Sugandha S, Weiss JM, Dwyer MA, and Ogba N
- Subjects
- Age Factors, Aged, Aged, 80 and over, Biomarkers, Tumor blood, Biomarkers, Tumor genetics, Biomarkers, Tumor isolation & purification, Colonoscopy methods, Colonoscopy standards, Colorectal Neoplasms blood, Colorectal Neoplasms genetics, Colorectal Neoplasms pathology, DNA, Neoplasm genetics, DNA, Neoplasm isolation & purification, Early Detection of Cancer methods, Feces chemistry, Humans, Immunochemistry methods, Immunochemistry standards, Mass Screening methods, Medical Oncology methods, Middle Aged, Occult Blood, Randomized Controlled Trials as Topic, Septins genetics, Societies, Medical standards, Time Factors, Tomography, X-Ray Computed methods, Tomography, X-Ray Computed standards, United States, Colorectal Neoplasms diagnosis, Early Detection of Cancer statistics & numerical data, Mass Screening standards, Medical Oncology standards
- Abstract
The NCCN Guidelines for Colorectal Cancer (CRC) Screening outline various screening modalities as well as recommended screening strategies for individuals at average or increased-risk of developing sporadic CRC. The NCCN panel meets at least annually to review comments from reviewers within their institutions, examine relevant data, and reevaluate and update their recommendations. These NCCN Guidelines Insights summarize 2018 updates to the NCCN Guidelines, with a primary focus on modalities used to screen individuals at average-risk for CRC., (Copyright © 2018 by the National Comprehensive Cancer Network.)
- Published
- 2018
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20. Real-World Safety and Efficacy of Fluid-Filled Dual Intragastric Balloon for Weight Loss.
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Agnihotri A, Xie A, Bartalos C, Kushnir V, Sullivan S, Islam S, Islam E, Lamet M, Lamet A, Farboudmanesch R, Overholt BF, Altawil J, Early DS, Bennett M, Lowe A, Mullady DK, Adeyeri CS, El Zein M, Mishra P, Fayad L, Dunlap M, Oberbach A, Cheskin LJ, Kalloo AN, Khashab MA, and Kumbhari V
- Subjects
- Adult, Female, Humans, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Bariatrics adverse effects, Bariatrics methods, Gastric Balloon adverse effects, Obesity therapy, Weight Loss
- Abstract
Background & Aims: Reshape Duo is a saline-filled dual, integrated intragastric balloon (IGB) approved by the Food and Drug Administration for weight loss in patients with obesity. In a prospective, randomized trial, obese patients who received the balloon had significantly greater percent excess weight loss (%EWL) compared with patients treated with diet and exercise alone. However, there are limited data on the real-world efficacy of the Reshape balloon., Methods: We performed a retrospective study of data collected from 2 academic centers and 5 private practices in which all patients paid for the IGB and follow-up visits out of pocket. The IGB was removed after 6 months. We collected data (demographic, medical, and laboratory) from 202 adults (mean age 47.8 ± 10.8 years; 83% female) with a baseline mean body mass index of 36.8 + 8.4 kg/m
2 who had IGB insertion for weight loss therapy, along with counselling on lifestyle modifications focused on diet and exercise. Primary outcomes were percent total body weight loss (%TBWL) and %EWL at 1, 3, 6, 9, and 12 months after the procedure., Results: Mean %TBWL at 1, 3, 6, 9 and 12 months was 4.8 ± 2.4%, 8.8 ± 4.3%, 11.4 ± 6.7%, 13.3 ± 7.8%, and 14.7 ± 11.8%, respectively. Data were available from 101 patients at 6 months and 12 patients at 12 months; 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL. Seventeen patients (8.4%) had esophageal tears during balloon insertion, with no intervention required. Thirteen patients (6.4%) had their IGB removed before the end of the 6-month treatment period. Nausea, vomiting, and abdominal pain were the most common adverse effects, occurring in 149 (73.8%), 99 (49%), and 51 (25.2%) patients. In one patient, the IGB migrated distally leading to small intestinal obstruction requiring surgical removal., Conclusion: In a retrospective analysis of real-world patients who received the Reshape Duo IGB, we found it to be a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at 6 months., (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)- Published
- 2018
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21. The effects of graded caloric restriction: XII. Comparison of mouse to human impact on cellular senescence in the colon.
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Fontana L, Mitchell SE, Wang B, Tosti V, van Vliet T, Veronese N, Bertozzi B, Early DS, Maissan P, Speakman JR, and Demaria M
- Subjects
- Animals, Disease Models, Animal, Humans, Mice, Aging, Caloric Restriction methods, Cellular Senescence genetics, Colon physiopathology, Diet methods
- Abstract
Calorie restriction (CR) is an effective strategy to delay the onset and progression of aging phenotypes in a variety of organisms. Several molecular players are involved in the anti-aging effects of CR, but mechanisms of regulation are poorly understood. Cellular senescence-a cellular state of irreversible growth arrest-is considered a basic mechanism of aging. Senescent cells accumulate with age and promote a number of age-related pathologies. Whether environmental conditions such as diet affect the accumulation of cellular senescence with age is still unclear. Here, we show that a number of classical transcriptomic markers of senescent cells are reduced in adult but relatively young mice under CR. Moreover, we demonstrate that such senescence markers are not induced in the colon of middle-age human volunteers under CR in comparison with age-matched volunteers consuming normal Western diets. Our data support the idea that the improvement in health span observed in different organisms under CR might be partly due to a reduction in the number of senescent cells., (© 2018 The Authors. Aging Cell published by the Anatomical Society and John Wiley & Sons Ltd.)
- Published
- 2018
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22. Acute graft-versus-host disease following lung transplantation in a patient with a novel TERT mutation.
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Brestoff JR, Vessoni AT, Brenner KA, Uy GL, DiPersio JF, Blinder M, Witt CA, Byers DE, Hachem RR, Truclock EP, Early DS, Anadkat MJ, Musiek A, Javidan-Nejad C, Balfe DM, Rosman IS, Liu C, Zhang L, Despotis GJ, Ruzinova MB, Sehn JK, Amarillo I, Heusel JW, Swat W, Kim BS, Wartman LD, Yusen RD, and Batista LFZ
- Subjects
- Acute Disease, Fatal Outcome, Female, Graft vs Host Disease pathology, Humans, Mutation, Pulmonary Fibrosis surgery, Telomerase metabolism, Graft vs Host Disease etiology, Lung Transplantation adverse effects, Pulmonary Fibrosis genetics, Telomerase genetics
- Abstract
Familial pulmonary fibrosis is associated with loss-of-function mutations in telomerase reverse transcriptase ( TERT ) and short telomeres. Interstitial lung diseases have become the leading indication for lung transplantation in the USA, and recent data indicate that pathogenic mutations in telomerase may cause unfavourable outcomes following lung transplantation. Although a rare occurrence, solid organ transplant recipients who develop acute graft-versus-host disease (GVHD) have very poor survival. This case report describes the detection of a novel mutation in TERT in a patient who had lung transplantation for familial pulmonary fibrosis and died from complications of acute GVHD., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
- Published
- 2018
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23. Guidelines for sedation and anesthesia in GI endoscopy.
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Early DS, Lightdale JR, Vargo JJ 2nd, Acosta RD, Chandrasekhara V, Chathadi KV, Evans JA, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Muthusamy VR, Pasha SF, Saltzman JR, Shergill AK, Cash BD, and DeWitt JM
- Subjects
- Analgesics, Opioid administration & dosage, Anesthesiology standards, Anesthetics, Intravenous administration & dosage, Benzodiazepines administration & dosage, Endoscopy, Gastrointestinal methods, Humans, Hypnotics and Sedatives administration & dosage, Monitoring, Intraoperative standards, Preoperative Care standards, Propofol administration & dosage, Anesthesia standards, Conscious Sedation standards, Deep Sedation standards, Endoscopy, Gastrointestinal standards
- Published
- 2018
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24. EUS-guided drainage of peripancreatic fluid collections with lumen-apposing metal stents and plastic double-pigtail stents: comparison of efficacy and adverse event rates.
- Author
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Lang GD, Fritz C, Bhat T, Das KK, Murad FM, Early DS, Edmundowicz SA, Kushnir VM, and Mullady DK
- Subjects
- Adolescent, Adult, Aged, Endosonography, Humans, Middle Aged, Pancreatitis, Acute Necrotizing surgery, Postoperative Hemorrhage epidemiology, Retrospective Studies, Stents, Surgery, Computer-Assisted, Young Adult, Pancreatic Diseases surgery, Plastics, Postoperative Complications epidemiology, Self Expandable Metallic Stents
- Abstract
Background and Aims: Transmural drainage with double-pigtail plastic stents (DPPSs) was the mainstay of endoscopic therapy for symptomatic peripancreatic fluid collections (PPFCs) until the introduction of lumen-apposing covered self-expanding metal stents (LAMSs). Currently, there are limited data regarding the efficacy and adverse event rate of LAMSs compared with DPPSs., Methods: A retrospective analysis of EUS-guided PPFC drainage at a single tertiary care center between 2008 and 2015 was performed. Patients were classified based on drainage method: DPPSs and LAMSs. Adverse event rates, unplanned endoscopic procedures/necrosectomies, and PPFC resolution within 6 months were recorded. Significant bleeding was defined as necessitating transfusion or requiring endoscopic treatment/radiographic embolization. Subsequent endoscopic procedures were defined as unplanned procedures; stent removals were excluded., Results: A total of 103 patients met inclusion criteria (84 DPPSs, 19 LAMSs). PPFCs were classified as walled-off necrosis (WON) in 23 (14 DPPSs, 9 LAMSs). There were significantly more bleeding episodes in the LAMS group (4 [19%]: 2 splenic artery pseudo-aneurysms, 1 collateral vessel bleed, 1 intracavitary variceal bleed; P = .0003) than in the DPPS group (1 (1%]: stent erosion into the gastric wall). One perforation occurred in the DPPS group. Unplanned repeat endoscopy was more frequent in the LAMS group (10% vs 26%, P = .07). Among retreated LAMS patients in with WON, 5 (56%) had obstruction by necrotic debris. In patients for whom follow-up was available, 67 of 70 (96%) with DPPSs and 16 of 17 (94%) with LAMSs had resolution of PPFCs within 6 months (P = .78)., Conclusions: DPPSs and LAMSs are effective methods for treatment of PPFCs. In our cohort, use of LAMSs was associated with significantly higher rates of procedure-related bleeding and greater need for repeat endoscopic intervention., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
- Published
- 2018
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25. NCCN Guidelines Insights: Genetic/Familial High-Risk Assessment: Colorectal, Version 3.2017.
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Gupta S, Provenzale D, Regenbogen SE, Hampel H, Slavin TP, Hall MJ, Llor X, Chung DC, Ahnen DJ, Bray T, Cooper G, Early DS, Ford JM, Giardiello FM, Grady W, Halverson AL, Hamilton SR, Klapman JB, Larson DW, Lazenby AJ, Lynch PM, Markowitz AJ, Mayer RJ, Ness RM, Samadder NJ, Shike M, Sugandha S, Weiss JM, Dwyer MA, and Ogba N
- Subjects
- Genetics, Humans, Risk Assessment methods, Risk Factors, Colorectal Neoplasms etiology, Colorectal Neoplasms genetics
- Abstract
The NCCN Guidelines for Genetic/Familial High-Risk Assessment: Colorectal provide recommendations for the management of patients with high-risk syndromes associated with an increased risk of colorectal cancer (CRC). The NCCN Panel for Genetic/Familial High-Risk Assessment: Colorectal meets at least annually to assess comments from reviewers within their institutions, examine relevant data, and reevaluate and update their recommendations. These NCCN Guidelines Insights focus on genes newly associated with CRC risk on multigene panels, the associated evidence, and currently recommended management strategies., (Copyright © 2017 by the National Comprehensive Cancer Network.)
- Published
- 2017
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26. A Prospective Multicenter Study Evaluating Learning Curves and Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography Among Advanced Endoscopy Trainees: The Rapid Assessment of Trainee Endoscopy Skills Study.
- Author
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Wani S, Keswani R, Hall M, Han S, Ali MA, Brauer B, Carlin L, Chak A, Collins D, Cote GA, Diehl DL, DiMaio CJ, Dries A, El-Hajj I, Ellert S, Fairley K, Faulx A, Fujii-Lau L, Gaddam S, Gan SI, Gaspar JP, Gautamy C, Gordon S, Harris C, Hyder S, Jones R, Kim S, Komanduri S, Law R, Lee L, Mounzer R, Mullady D, Muthusamy VR, Olyaee M, Pfau P, Saligram S, Piraka C, Rastogi A, Rosenkranz L, Rzouq F, Saxena A, Shah RJ, Simon VC, Small A, Sreenarasimhaiah J, Walker A, Wang AY, Watson RR, Wilson RH, Yachimski P, Yang D, Edmundowicz S, and Early DS
- Subjects
- Humans, Program Evaluation, Prospective Studies, Cholangiopancreatography, Endoscopic Retrograde methods, Clinical Competence, Endosonography methods, Gastroenterology education, Gastrointestinal Diseases diagnosis, Learning Curve
- Abstract
Background & Aims: On the basis of the Next Accreditation System, trainee assessment should occur on a continuous basis with individualized feedback. We aimed to validate endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) learning curves among advanced endoscopy trainees (AETs) by using a large national sample of training programs and to develop a centralized database that allows assessment of performance in relation to peers., Methods: ASGE recognized training programs were invited to participate, and AETs were graded on ERCP and EUS exams by using a validated competency assessment tool that assesses technical and cognitive competence in a continuous fashion. Grading for each skill was done by using a 4-point scoring system, and a comprehensive data collection and reporting system was built to create learning curves by using cumulative sum analysis. Individual results and benchmarking to peers were shared with AETs and trainers quarterly., Results: Of the 62 programs invited, 20 programs and 22 AETs participated in this study. At the end of training, median number of EUS and ERCP performed/AET was 300 (range, 155-650) and 350 (125-500), respectively. Overall, 3786 exams were graded (EUS, 1137; ERCP-biliary, 2280; ERCP-pancreatic, 369). Learning curves for individual end points and overall technical/cognitive aspects in EUS and ERCP demonstrated substantial variability and were successfully shared with all programs. The majority of trainees achieved overall technical (EUS, 82%; ERCP, 60%) and cognitive (EUS, 76%; ERCP, 100%) competence at conclusion of training., Conclusions: These results demonstrate the feasibility of establishing a centralized database to report individualized learning curves and confirm the substantial variability in time to achieve competence among AETs in EUS and ERCP. ClinicalTrials.gov: NCT02509416., (Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Published
- 2017
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27. Increasing Number of Passes Beyond 4 Does Not Increase Sensitivity of Detection of Pancreatic Malignancy by Endoscopic Ultrasound-Guided Fine-Needle Aspiration.
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Mohamadnejad M, Mullady D, Early DS, Collins B, Marshall C, Sams S, Yen R, Rizeq M, Romanas M, Nawaz S, Ulusarac O, Hollander T, Wilson RH, Simon VC, Kushnir V, Amateau SK, Brauer BC, Gaddam S, Azar RR, Komanduri S, Shah R, Das A, Edmundowicz S, Muthusamy VR, Rastogi A, and Wani S
- Subjects
- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Prospective Studies, Sensitivity and Specificity, Tertiary Care Centers, Biopsy, Fine-Needle methods, Endosonography methods, Neoplasms diagnosis, Pancreatic Neoplasms diagnosis
- Abstract
Background & Aims: It is not clear exactly how many passes are required to determine whether pancreatic masses are malignant using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). We aimed to define the per-pass diagnostic yield of EUS-FNA for establishing the malignancy of a pancreatic mass, and identify factors associated with detection of malignancies., Methods: In a prospective study, 239 patients with solid pancreatic masses were randomly assigned to groups that underwent EUS-FNA, with the number of passes determined by an on-site cytopathology evaluation or set at 7 passes, at 3 tertiary referral centers. A final diagnosis of pancreatic malignancy was made based on findings from cytology, surgery, or a follow-up evaluation at least 1 year after EUS-FNA. The cumulative sensitivity of detection of malignancy by EUS-FNA was calculated after each pass; in the primary analysis, lesions categorized as malignant or suspicious were considered as positive findings., Results: Pancreatic malignancies were found in 202 patients (84.5% of the study population). EUS-FNA detected malignancies with 96% sensitivity (95% confidence interval [CI], 92%-98%); 4 passes of EUS-FNA detected malignancies with 92% sensitivity (95% CI, 87%-95%). Tumor size greater than 2 cm was the only variable associated with positive results from cytology analysis (odds ratio, 7.8; 95% CI, 1.9-31.6). In masses larger than 2 cm, 4 passes of EUS-FNA detected malignancies with 93% sensitivity (95% CI, 89%-96%) and in masses ≤2 cm, 6 passes was associated with 82% sensitivity (95% CI, 61%-93%). Sensitivity of detection did not increase with increasing number of passes., Conclusions: In a prospective study, we found 4 passes of EUS-FNA to be sufficient to detect malignant pancreatic masses; increasing the number of passes did not increase the sensitivity of detection. Tumor size greater than 2 cm was associated with malignancy, and a greater number of passes may be required to evaluate masses 2 cm or less. ClinicalTrials.gov number, NCT01386931., (Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Published
- 2017
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28. Recurrence of intestinal metaplasia and early neoplasia after endoscopic eradication therapy for Barrett's esophagus: a systematic review and meta-analysis.
- Author
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Fujii-Lau LL, Cinnor B, Shaheen N, Gaddam S, Komanduri S, Muthusamy VR, Das A, Wilson R, Simon VC, Kushnir V, Mullady D, Edmundowicz SA, Early DS, and Wani S
- Abstract
Background: Conflicting data exist with regard to recurrence rates of intestinal metaplasia (IM) and dysplasia after achieving complete eradication of intestinal metaplasia (CE-IM) in Barrett's esophagus (BE) patients., Aim: (i) To determine the incidence of recurrent IM and dysplasia achieving CE-IM and (ii) to compare recurrence rates between treatment modalities [radiofrequency ablation (RFA) with or without endoscopic mucosal resection (EMR) vs stepwise complete EMR (SRER)]., Methods: A systematic search was performed for studies reporting on outcomes and estimates of recurrence rates after achieving CE-IM. Pooled incidence [per 100-patient-years (PY)] and risk ratios with 95 %CI were obtained. Heterogeneity was measured using the I
2 statistic. Subgroup analyses, decided a priori, were performed to explore heterogeneity in results., Results: A total of 39 studies were identified (25-RFA, 13-SRER, and 2 combined). The pooled incidence of any recurrence was 7.5 (95 %CI 6.1 - 9.0)/100 PY with a pooled incidence of IM recurrence rate of 4.8 (95 %CI 3.8 - 5.9)/100 PY, and dysplasia recurrence rate of 2.0 (95 %CI 1.5 - 2.5)/100 PY. Compared to the SRER group, the RFA group had significantly higher overall [8.6 (6.7 - 10.5)/100 PY vs. 5.1 (3.1 - 7)/100 PY, P = 0.01] and IM recurrence rates [5.8 (4.3 - 7.3)/100 PY vs. 3.1 (1.7 - 4)/100 PY, P < 0.01] with no difference in recurrence rates of dysplasia. Significant heterogeneity between studies was identified. The majority of recurrences were amenable to repeat endoscopic eradication therapy (EET)., Conclusion: The results of this study demonstrate that the incidence rates of overall, IM, and dysplasia recurrence rates post-EET are not inconsiderable and reinforce the importance of close surveillance after achieving CE-IM.- Published
- 2017
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29. A clinically feasible multiplex proteomic immunoassay as a novel functional diagnostic for pancreatic ductal adenocarcinoma.
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Lim KH, Langley E, Gao F, Luo J, Li L, Meyer G, Kim P, Singh S, Kushnir VM, Early DS, Mullady DK, Edmundowicz SA, Wani S, Murad FM, Cao D, Azar RR, and Wang-Gillam A
- Subjects
- Adult, Aged, Aged, 80 and over, Biopsy, Fine-Needle, Carcinoma, Pancreatic Ductal mortality, Carcinoma, Pancreatic Ductal therapy, Endosonography methods, Female, Humans, Male, Middle Aged, Neoplasm Staging, Pancreatic Neoplasms mortality, Pancreatic Neoplasms therapy, Prognosis, Reproducibility of Results, Pancreatic Neoplasms, Biomarkers, Tumor, Carcinoma, Pancreatic Ductal diagnosis, Carcinoma, Pancreatic Ductal metabolism, Immunoassay methods, Pancreatic Neoplasms diagnosis, Pancreatic Neoplasms metabolism, Proteomics methods
- Abstract
To date, targeted therapy for pancreatic ductal adenocarcinoma (PDAC) remains largely unsuccessful in the clinic. Current genomics-based technologies are unable to reflect the quantitative, dynamic signaling changes in the tumor, and require larger tumor samples that are difficult to obtain in PDAC patients. Therefore, a highly sensitive functional tool that can reliably and comprehensively inform intra-tumoral signaling events is direly needed to guide treatment decision. We tested the utility of a highly sensitive proteomics-based functional diagnostic platform, Collaborative Enzyme Enhanced Reactive-immunoassay (CEERTM), on fine-needle aspiration (FNA) samples obtained from 102 patients with radiographically-evident pancreatic tumors. Two FNA passes were collected from each patient, hybridized to customized chips coated with an array of capture antibodies, and detected using two enzyme-conjugated antibodies which emit quantifiable signals. We demonstrate that this technique is highly sensitive in detecting total and phosphorylated forms of multiple signaling molecules in FNA specimens, with reasonable correlation of marker intensities between two different FNA passes. Notably, signals of several markers were significantly higher in PDAC compared to non-cancerous samples. In PDAC samples, we found high total c-Met signal to be associated with poor survival, and confirmed this finding using an independent PDAC tissue microarray.
- Published
- 2017
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30. Evaluation of the 2015 AGA guidelines on pancreatic cystic neoplasms in a large surgically confirmed multicenter cohort.
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Ge PS, Muthusamy VR, Gaddam S, Jaiyeola DM, Kim S, Sedarat A, Donahue TR, Hosford L, Wilson RH, Grande DP, Keswani RN, Kushnir VM, Mullady D, Edmundowicz SA, Early DS, Komanduri S, Wani S, and Watson RR
- Abstract
Background and study aims The American Gastroenterological Association (AGA) recently published guidelines for the management of asymptomatic pancreatic cystic neoplasms (PCNs). We aimed to evaluate the diagnostic characteristics of the AGA guidelines in appropriately recommending surgery for malignant PCNs. Patients and methods A retrospective multicenter study was performed of patients who underwent endoscopic ultrasound (EUS) for evaluation of PCNs who ultimately underwent surgical resection from 2004 - 2014. Demographics, EUS characteristics, fine-needle aspiration (FNA) results, type of resection, and final pathologic diagnosis were recorded. Patients were categorized into 2 groups (surgery or surveillance) based on what the AGA guidelines would have recommended. Performance characteristics for the diagnosis of cancer or high-grade dysplasia (HGD) on surgical pathology were calculated. Results Three hundred patients underwent surgical resection for PCNs, of whom the AGA guidelines would have recommended surgery in 121 (40.3 %) and surveillance in 179 (59.7 %) patients. Among patients recommended for surgery, 45 (37.2 %) had cancer, whereas 76 (62.8 %) had no cancer/HGD. Among patients recommended for surveillance, 170 (95.0 %) had no cancer/HGD; however, 9 (5.0 %) patients had cancer that would have been missed. For the finding of cancer/HGD on surgical pathology, the AGA guidelines had 83.3 % sensitivity (95 % CI 70.7 - 92.1), 69.1 % specificity (95 % CI 62.9 - 74.8), 37.2 % positive predictive value (95 % CI 28.6 - 46.4), 95.0 % negative predictive value (95 % CI 90.7 - 97.7), and 71.7 % accuracy (95 % CI 67.4 - 74.6). Conclusions The 2015 AGA guidelines would have resulted in 60 % fewer patients being referred for surgical resection, and accurately recommended surveillance in 95 % of patients with asymptomatic PCNs. Future prospective studies are required to validate these guidelines. Meeting presentations: Presented in part at Digestive Diseases Week 2016.
- Published
- 2017
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31. Impact and outcomes of research sponsored by the American Society for Gastrointestinal Endoscopy.
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Madhoun MF, Cote GA, Ahlawat SK, Ahmad NA, Buscaglia JM, Calderwood AH, Crockett S, Early DS, Gleeson FC, Gurudu SR, Imperiale TF, Liu JJ, Mosler P, Pannala R, Pfau PR, Romagnuolo J, Samadder J, Sethi A, Shergill AK, Shin EJ, Willingham F, and Dominitz JA
- Subjects
- Cohort Studies, Efficiency, Endoscopy, Gastrointestinal, Female, Humans, Male, National Institutes of Health (U.S.), Publishing, Research Personnel, Retrospective Studies, Societies, Medical, United States, Biomedical Research, Gastroenterology, Research Support as Topic
- Abstract
Background and Aims: Since 1985, the American Society for Gastrointestinal Endoscopy (ASGE) has awarded grants for endoscopic-related research. The goals of this study were to examine trends in ASGE grant funding and to assess productivity of previous recipients of the ASGE grant awards., Methods: This was a retrospective cohort analysis of all research grants awarded by the ASGE through 2009. Measures of academic productivity and self-assessment of the ASGE awards' impact on the recipients' careers were defined by using publicly available resources (eg, National Library of Medicine-PubMed) and administration of an electronic survey to award recipients., Results: The ASGE awarded 304 grants totaling $12.5 million to 214 unique awardees. Funding increased 7.5-fold between 1985 and 1989 (mean $102,000/year) and between 2005 and 2009 (mean $771,000/year). The majority of awardees were men (83%), were at or below the level of assistant professor (82%), with a median of 3 years of postfellowship experience at the time of the award, and derived from a broad spectrum of institutions as measured by National Institutes of Health funding rank (median 26, interquartile range [IQR] 12-64). Nineteen percent had a master's degree in a research-related field. Awardees' median publications per year increased from 3.5 (IQR 1.2-9.0) before funding to 5.7 (IQR 1.8-9.5) since funding; P = .04, and median h-index scores increased from 3 (IQR 1-8) to 17 (IQR 8-26); P < .001. Multivariate analysis found that the presence of a second advanced degree (eg, masters or doctorate) was independently predictive of high productivity (odds ratio [OR] 2.92; 95% confidence interval [CI], 1.09-7.81). Among 212 unique grant recipients, 82 (40%) completed the online survey. Of the respondents, median peer-reviewed publications per year increased from 3.4 (IQR 1.9-5.5) to 4.5 (IQR 2.0-9.5); P = .17. Ninety-one percent reported that the ASGE grant had a positive or very positive impact on their careers, and 85% of respondents are currently practicing in an academic environment. Most of the grants resulted in at least 1 peer-reviewed publication (67% per Internet-based search and 81% per survey)., Conclusions: The ASGE research program has grown considerably since 1985, with the majority of grants resulting in at least 1 grant-related publication. Overall academic productivity increased after the award, and the majority of awardees report a positive or very positive impact of the award on their careers. Medical professional societies are an important sponsor of clinical research., (Copyright © 2016. Published by Elsevier Inc.)
- Published
- 2016
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32. A comparison between endoscopic ultrasound-guided rendezvous and percutaneous biliary drainage after failed ERCP for malignant distal biliary obstruction.
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Bill JG, Darcy M, Fujii-Lau LL, Mullady DK, Gaddam S, Murad FM, Early DS, Edmundowicz SA, and Kushnir VM
- Abstract
Background and Study Aims: Selective biliary cannulation is unsuccessful in 5 % to 10 % of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) for malignant distal biliary obstruction (MDBO). Percutaneous biliary drainage (PBD) has been the gold standard, but endoscopic ultrasound guided rendezvous (EUSr) have been increasingly used for biliary decompression in this patient population. Our aim was to compare the initial success rate, long-term efficacy, and safety of PBD and EUSr in relieving MDBO after failed ERC Patients and methods: A retrospective study involving 50 consecutive patients who had an initial failed ERCP for MDBO. Twenty-five patients undergoing EUSr between 2008 - 2014 were compared to 25 patients who underwent PBD immediately prior to the introduction of EUSr at our center (2002 - 2008). Comparisons were made between the two groups with regard to technical success, duration of hospital stay and adverse event rates after biliary decompression., Results: The mean age at presentation was 66.5 (± 12.6 years), 28 patients (54.9 %) were female. The etiology of MDBO was pancreaticobiliary malignancy in 44 (88 %) and metastatic disease in 6 (12 %) cases. Biliary drainage was technically successful by EUSr in 19 (76 %) cases and by PBD in 25 (100 %) (P = 0.002). Median length of hospital stay after initial drainage was 1 day in the EUSr group vs 5 days in PBD group (P = 0.02). Repeat biliary intervention was required for 4 patients in the EUSr group and 15 in the PBD group (P = 0.001)., Conclusions: Initial technical success with EUSr was significantly lower than with PBD, however when EUSr was successful, patients had a significantly shorter post-procedure hospital stay and required fewer follow-up biliary interventions. Meeting presentations: Annual Digestive Diseases Week 2015.
- Published
- 2016
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33. Genetic/Familial High-Risk Assessment: Colorectal Version 1.2016, NCCN Clinical Practice Guidelines in Oncology.
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Provenzale D, Gupta S, Ahnen DJ, Bray T, Cannon JA, Cooper G, David DS, Early DS, Erwin D, Ford JM, Giardiello FM, Grady W, Halverson AL, Hamilton SR, Hampel H, Ismail MK, Klapman JB, Larson DW, Lazenby AJ, Lynch PM, Mayer RJ, Ness RM, Regenbogen SE, Samadder NJ, Shike M, Steinbach G, Weinberg D, Dwyer M, and Darlow S
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- Colorectal Neoplasms diagnosis, Colorectal Neoplasms epidemiology, Colorectal Neoplasms genetics, Colorectal Neoplasms therapy, Colorectal Neoplasms, Hereditary Nonpolyposis epidemiology, Colorectal Neoplasms, Hereditary Nonpolyposis genetics, Disease Management, Early Detection of Cancer methods, Germ-Line Mutation, Humans, Population Surveillance, Risk Assessment, Colorectal Neoplasms, Hereditary Nonpolyposis diagnosis, Colorectal Neoplasms, Hereditary Nonpolyposis therapy
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This is a focused update highlighting the most current NCCN Guidelines for diagnosis and management of Lynch syndrome. Lynch syndrome is the most common cause of hereditary colorectal cancer, usually resulting from a germline mutation in 1 of 4 DNA mismatch repair genes (MLH1, MSH2, MSH6, or PMS2), or deletions in the EPCAM promoter. Patients with Lynch syndrome are at an increased lifetime risk, compared with the general population, for colorectal cancer, endometrial cancer, and other cancers, including of the stomach and ovary. As of 2016, the panel recommends screening all patients with colorectal cancer for Lynch syndrome and provides recommendations for surveillance for early detection and prevention of Lynch syndrome-associated cancers., (Copyright © 2016 by the National Comprehensive Cancer Network.)
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- 2016
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34. Evaluation of patients with abnormalities on intraoperative cholangiogram: time to abandon endoscopic retrograde cholangiopancreatography as the initial follow-up study.
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Bill JG, Kushnir VM, Mullady DK, Murad FM, Azar RR, Easler JJ, Early DS, and Edmundowicz SA
- Abstract
Background: Endoscopic retrograde cholangiopancreatography (ERCP) is currently the method of choice for the postoperative evaluation of suspected bile duct stones seen on intraoperative cholangiogram (IOC); however, the sensitivity of IOC for identifying biliary pathology is unclear, with studies reporting false positive rates between 30% and 60%., Objective: Evaluate the sensitivity of IOC for biliary pathology, using ERCP with sphincterotomy and balloon sweep as gold standard., Design: Retrospective cohort study., Setting: Tertiary medical centre., Patients: 130 consecutive patients (age 51.3±1.7 years, 69.2% women) who underwent ERCP for the evaluation of abnormalities identified on IOC between 2005 and 2013., Interventions: Endoscopic retrograde cholangiopancreatography., Main Outcome Measurements: Sensitivity of IOC, identify predictors of positive postoperative ERCP and ERCP-related complications., Results: ERCP was successful in all 130 subjects. ERCP-related adverse events occurred in six (4.3%) patients, including self-limited post-sphincterotomy bleeding in three (2.3%) and mild post-ERCP pancreatitis in three (2.3%). Overall, 41 (31.5%) patients had normal cholangiogram at time of ERCP. Finding of a filling defect on IOC was the only predictor for the presence of common bile duct stones on postoperative ERCP (OR 3.3, 95% CI 1.0 to 10.8, p=0.05)., Limitations: Retrospective study design., Conclusions: Nearly one-third of patients with abnormal IOC had a normal postoperative ERCP. Significant pathology could have been missed in 1/130 patients. Based on these findings, we believe the use of less-invasive diagnostic modalities may be used in place of ERCP in patients with suspected choledocholithiasis on IOC.
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- 2016
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35. The role of endoscopy in the evaluation and management of patients with solid pancreatic neoplasia.
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Eloubeidi MA, Decker GA, Chandrasekhara V, Chathadi KV, Early DS, Evans JA, Fanelli RD, Fisher DA, Foley K, Hwang JH, Jue TL, Lightdale JR, Pasha SF, Saltzman JR, Sharaf R, Shergill AK, Cash BD, and DeWitt JM
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- Carcinoma, Pancreatic Ductal surgery, Cholangiopancreatography, Endoscopic Retrograde, Endoscopic Ultrasound-Guided Fine Needle Aspiration, Endosonography, Humans, Lymphoma surgery, Magnetic Resonance Imaging, Neuroendocrine Tumors surgery, Pancreatic Neoplasms surgery, Positron-Emission Tomography, Tomography, X-Ray Computed, Carcinoma, Pancreatic Ductal diagnosis, Endoscopy, Digestive System, Lymphoma diagnosis, Neuroendocrine Tumors diagnosis, Pancreatic Neoplasms diagnosis
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- 2016
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36. Predictors for Surgical Referral in Patients With Pancreatic Cystic Lesions Undergoing Endoscopic Ultrasound: Results From a Large Multicenter Cohort Study.
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Ge PS, Gaddam S, Keach JW, Mullady D, Fukami N, Edmundowicz SA, Azar RR, Shah RJ, Murad FM, Kushnir VM, Ghassemi KF, Sedarat A, Watson RR, Amateau SK, Brauer BC, Yen RD, Hosford L, Hollander T, Donahue TR, Schulick RD, Edil BH, McCarter MD, Gajdos C, Attwell AR, Muthusamy VR, Early DS, and Wani S
- Subjects
- Aged, Endoscopic Ultrasound-Guided Fine Needle Aspiration, Female, Humans, Logistic Models, Male, Middle Aged, Multivariate Analysis, Odds Ratio, Predictive Value of Tests, Prognosis, Retrospective Studies, Risk Assessment, Risk Factors, United States, Watchful Waiting, Endosonography, Neoplasms, Cystic, Mucinous, and Serous diagnostic imaging, Neoplasms, Cystic, Mucinous, and Serous surgery, Pancreatectomy, Pancreatic Cyst diagnostic imaging, Pancreatic Cyst surgery, Pancreatic Neoplasms diagnostic imaging, Pancreatic Neoplasms surgery, Pancreaticoduodenectomy, Referral and Consultation
- Abstract
Objective: Endoscopic ultrasound (EUS) plays an integral role in the evaluation of pancreatic cysts lesions (PCLs). The aim of the study was to determine predictors of surgical referral in patients with PCLs undergoing EUS., Methods: We performed a multicenter retrospective study of patients undergoing EUS for evaluation of PCLs. Demographics, EUS characteristics, and fine-needle aspiration results were recorded. Patients were categorized into surgery or surveillance groups on the basis of post-EUS recommendations. Univariate and multivariate analyses were performed to identify predictors of surgical referral., Results: 1804 patients were included. 1301 patients were recommended to undergo surveillance and 503 patients were referred for surgical evaluation, of which 360 patients underwent surgery. Multivariate analysis revealed the following 5 independent predictors of surgical referral: symptoms of weight loss on presentation (odds ratio [OR], 2.69; 95% confidence interval [CI], 1.44-5.03), EUS findings of associated solid mass (OR, 7.34; 95% CI, 3.81-14.16), main duct communication (OR, 4.13; 95% CI, 1.71-9.98), multilocular macrocystic morphology (OR, 2.79; 95% CI, 1.78-4.38), and fine-needle aspiration findings of mucin on cytology (OR, 3.06; 95% CI, 1.94-4.82)., Conclusions: This study identifies factors associated with surgical referral in patients with PCLs undergoing EUS. Future studies should focus on creation of risk stratification models to determine the need for surgery or enrollment in surveillance programs.
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- 2016
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37. The management of antithrombotic agents for patients undergoing GI endoscopy.
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Acosta RD, Abraham NS, Chandrasekhara V, Chathadi KV, Early DS, Eloubeidi MA, Evans JA, Faulx AL, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Shaukat A, Shergill AK, Wang A, Cash BD, and DeWitt JM
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- Anticoagulants adverse effects, Fibrinolytic Agents adverse effects, Humans, Platelet Aggregation Inhibitors adverse effects, Postoperative Hemorrhage chemically induced, Anticoagulants therapeutic use, Blood Loss, Surgical prevention & control, Endoscopy, Gastrointestinal methods, Fibrinolytic Agents therapeutic use, Platelet Aggregation Inhibitors therapeutic use, Postoperative Hemorrhage prevention & control
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- 2016
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38. Suboptimal accuracy of carcinoembryonic antigen in differentiation of mucinous and nonmucinous pancreatic cysts: results of a large multicenter study.
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Gaddam S, Ge PS, Keach JW, Mullady D, Fukami N, Edmundowicz SA, Azar RR, Shah RJ, Murad FM, Kushnir VM, Watson RR, Ghassemi KF, Sedarat A, Komanduri S, Jaiyeola DM, Brauer BC, Yen RD, Amateau SK, Hosford L, Hollander T, Donahue TR, Schulick RD, Edil BH, McCarter M, Gajdos C, Attwell A, Muthusamy VR, Early DS, and Wani S
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- Adult, Aged, Aged, 80 and over, Cystadenocarcinoma, Mucinous metabolism, Cystadenoma, Mucinous metabolism, Diagnosis, Differential, Endoscopic Ultrasound-Guided Fine Needle Aspiration, Female, Humans, Logistic Models, Male, Middle Aged, Multivariate Analysis, Pancreatic Neoplasms metabolism, ROC Curve, Retrospective Studies, Sensitivity and Specificity, Carcinoembryonic Antigen metabolism, Cystadenocarcinoma, Mucinous diagnosis, Cystadenoma, Mucinous diagnosis, Pancreatic Neoplasms diagnosis
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Background and Aims: The exact cutoff value at which pancreatic cyst fluid carcinoembryonic antigen (CEA) level distinguishes pancreatic mucinous cystic neoplasms (MCNs) from pancreatic nonmucinous cystic neoplasms (NMCNs) is unclear. The aim of this multicenter retrospective study was to evaluate the diagnostic accuracy of cyst fluid CEA levels in differentiating between MCNs and NMCNs., Methods: Consecutive patients who underwent EUS with FNA at 3 tertiary care centers were identified. Patients with histologic confirmation of cyst type based on surgical specimens served as the criterion standard for this analysis. Demographic characteristics, EUS morphology, FNA fluid, and cytology results were recorded. Multivariate logistic regression analysis to identify predictors of MCNs was performed. Receiver-operating characteristic (ROC) curves were generated for CEA levels., Results: A total of 226 patients underwent surgery (mean age, 61 years, 96% white patients, 39% female patients) of whom 88% underwent Whipple's procedure or distal pancreatectomy. Based on surgical histopathology, there were 150 MCNs and 76 NMCNs cases. The median CEA level was 165 ng/mL. The area under the ROC curve for CEA levels in differentiating between MCNs and NMCNs was 0.77 (95% confidence interval, 0.71-0.84, P < .01) with a cutoff of 105 ng/mL, demonstrating a sensitivity and specificity of 70% and 63%, respectively. The cutoff value of 192 ng/mL yielded a sensitivity of 61% and a specificity of 77% and would misdiagnose 39% of MCN cases., Conclusions: Cyst fluid CEA levels have a clinically suboptimal accuracy level in differentiating MCNs from NMCNs. Future studies should focus on novel cyst fluid markers to improve risk stratification of pancreatic cystic neoplasms., (Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
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- 2015
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39. Efficacy of Endoscopic Mucosal Resection for Management of Small Duodenal Neuroendocrine Tumors.
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Shroff SR, Kushnir VM, Wani SB, Gupta N, Jonnalagadda SS, Murad F, Early DS, Mullady DK, Edmundowicz SA, and Azar RR
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- Adult, Aged, Duodenal Neoplasms diagnosis, Endosonography, Female, Follow-Up Studies, Humans, Image-Guided Biopsy, Intestinal Mucosa diagnostic imaging, Intestinal Mucosa pathology, Male, Middle Aged, Neuroendocrine Tumors diagnosis, Retrospective Studies, Treatment Outcome, Dissection methods, Duodenal Neoplasms surgery, Endoscopy, Gastrointestinal methods, Intestinal Mucosa surgery, Neoplasm Staging, Neuroendocrine Tumors surgery
- Abstract
Background: Endoscopic mucosal resection (EMR) for small (<20 mm) duodenal neuroendocrine tumors (NETs) remains controversial because of their rarity., Materials and Methods: This is a retrospective cohort study of patients with surgically or endoscopically resected duodenal NETs from 2001 to 2011. The primary outcome is the rate of disease-free status following resection. A secondary outcome is the sensitivity of endoscopic ultrasound (EUS) in determining NET appropriateness for EMR., Results: Thirty patients underwent resection of duodenal NETs (EMR 20, surgery 10). Tumor was present at the margins in 40% of EMR-resected NETs and 10% of surgically resected NETs. Five patients who underwent EMR had residual disease treated with repeat EMR (3) and surgery (2). EUS demonstrated 96% sensitivity in determining lesions limited to the submucosa., Conclusions: EMR for small duodenal NETs can be a safe and effective alternative to surgery in carefully selected patients. EUS is a useful adjunct in determining depth of invasion for duodenal NETs.
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- 2015
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40. The clinical impact of immediate on-site cytopathology evaluation during endoscopic ultrasound-guided fine needle aspiration of pancreatic masses: a prospective multicenter randomized controlled trial.
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Wani S, Mullady D, Early DS, Rastogi A, Collins B, Wang JF, Marshall C, Sams SB, Yen R, Rizeq M, Romanas M, Ulusarac O, Brauer B, Attwell A, Gaddam S, Hollander TG, Hosford L, Johnson S, Kushnir V, Amateau SK, Kohlmeier C, Azar RR, Vargo J, Fukami N, Shah RJ, Das A, and Edmundowicz SA
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- Aged, Biopsy, Endoscopic Ultrasound-Guided Fine Needle Aspiration statistics & numerical data, Female, Humans, Male, Middle Aged, Pancreatic Diseases diagnosis, Pancreatic Diseases pathology, Pancreatic Neoplasms diagnosis, Pathology, Clinical statistics & numerical data, Sensitivity and Specificity, Endoscopic Ultrasound-Guided Fine Needle Aspiration methods, Pancreatic Neoplasms pathology, Pathology, Clinical methods
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Objectives: Observational data on the impact of on-site cytopathology evaluation (OCE) during endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) of pancreatic masses have reported conflicting results. We aimed to compare the diagnostic yield of malignancy and proportion of inadequate specimens between patients undergoing EUS-FNA of pancreatic masses with and without OCE., Methods: In this multicenter randomized controlled trial, consecutive patients with solid pancreatic mass underwent randomization for EUS-FNA with or without OCE. The number of FNA passes in the OCE+ arm was dictated by the on-site cytopathologist, whereas seven passes were performed in OCE- arm. EUS-FNA protocol was standardized, and slides were reviewed by cytopathologists using standardized criteria for cytologic characteristics and diagnosis., Results: A total of 241 patients (121 OCE+, 120 OCE-) were included. There was no difference between the two groups in diagnostic yield of malignancy (OCE+ 75.2% vs. OCE- 71.6%, P=0.45) and proportion of inadequate specimens (9.8 vs. 13.3%, P=0.31). Procedures in OCE+ group required fewer EUS-FNA passes (median, OCE+ 4 vs. OCE- 7, P<0.0001). There was no significant difference between the two groups with regard to overall procedure time, adverse events, number of repeat procedures, costs (based on baseline cost-minimization analysis), and accuracy (using predefined criteria for final diagnosis of malignancy). There was no difference between the two groups with respect to cytologic characteristics of cellularity, bloodiness, number of cells/slide, and contamination., Conclusions: Results of this study demonstrated no significant difference in the diagnostic yield of malignancy, proportion of inadequate specimens, and accuracy in patients with pancreatic mass undergoing EUS-FNA with or without OCE.
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- 2015
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41. Colorectal Cancer Screening, Version 1.2015.
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Provenzale D, Jasperson K, Ahnen DJ, Aslanian H, Bray T, Cannon JA, David DS, Early DS, Erwin D, Ford JM, Giardiello FM, Gupta S, Halverson AL, Hamilton SR, Hampel H, Ismail MK, Klapman JB, Larson DW, Lazenby AJ, Lynch PM, Mayer RJ, Ness RM, Rao MS, Regenbogen SE, Shike M, Steinbach G, Weinberg D, Dwyer MA, Freedman-Cass DA, and Darlow S
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- Colorectal Neoplasms mortality, Humans, Risk Factors, Colorectal Neoplasms diagnosis, Early Detection of Cancer methods
- Abstract
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Colorectal Cancer Screening provide recommendations for selecting individuals for colorectal cancer screening, and for evaluation and follow-up of colon polyps. These NCCN Guidelines Insights summarize major discussion points of the 2015 NCCN Colorectal Cancer Screening panel meeting. Major discussion topics this year were the state of evidence for CT colonography and stool DNA testing, bowel preparation procedures for colonoscopy, and guidelines for patients with a positive family history of colorectal cancer., (Copyright © 2015 by the National Comprehensive Cancer Network.)
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- 2015
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42. Patient preferences of a resect and discard paradigm.
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Vu HT, Sayuk GS, Gupta N, Hollander T, Kim A, and Early DS
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- Adenoma pathology, Adenoma surgery, Aged, Biopsy economics, Colonic Polyps pathology, Colonic Polyps surgery, Colonoscopy methods, Colorectal Neoplasms pathology, Colorectal Neoplasms surgery, Female, Health Care Costs, Humans, Male, Medical Waste Disposal, Middle Aged, Pathology, Clinical economics, Patient Preference economics, Prospective Studies, Specimen Handling, Surveys and Questionnaires, Adenoma psychology, Colonic Polyps psychology, Colonoscopy psychology, Colorectal Neoplasms psychology, Health Expenditures, Patient Preference psychology
- Abstract
Background: Resect and discard is a new paradigm for management of diminutive polyps. It is unknown whether patients will embrace this new paradigm in which small polyps would not be sent for histopathologic review., Objective: To determine whether patients would be willing to pay for pathology costs with their own money and which factors influence patients' decisions to pay or not pay for pathology costs with their own money., Design: Single-center, prospective, survey study., Setting: Hospital outpatient endoscopy center., Patients: Adults undergoing colonoscopy for screening or routine polyp surveillance., Interventions: Patient survey., Main Outcome Measurements: Willingness to pay out-of-pocket for pathology costs when a diminutive polyp is found and factors that influence patients' decisions to pay or not pay for pathology costs with their own money., Results: A total of 500 participants completed the survey. A total of 360 respondents (71.9%) indicated a hypothetical willingness to pay out-of-pocket for histopathologic polyp analysis if this interpretation was not covered by insurance. Patient factors significantly associated with willingness to pay for polyp analysis included higher income and education and female sex., Limitations: Single center, hypothetical situation., Conclusion: Over two-thirds of patients were willing to pay to have their diminutive polyp sent for pathologic evaluation if their insurance carrier would not pay the cost. Factors associated with willingness to pay included higher income, higher education, and female sex. Patients who were unwilling to pay raised concerns about cost and are less concerned about cancer risk compared with those willing to pay. (, Clinical Trial Registration Number: NCT02305251.)., (Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
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- 2015
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43. The role of endoscopy in benign pancreatic disease.
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Chandrasekhara V, Chathadi KV, Acosta RD, Decker GA, Early DS, Eloubeidi MA, Evans JA, Faulx AL, Fanelli RD, Fisher DA, Foley K, Fonkalsrud L, Hwang JH, Jue TL, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf R, Shaukat A, Shergill AK, Wang A, Cash BD, and DeWitt JM
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- Humans, Endoscopy, Digestive System, Endosonography, Pancreatic Diseases diagnosis, Pancreatic Diseases therapy
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- 2015
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44. The role of endoscopy in the management of premalignant and malignant conditions of the stomach.
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Evans JA, Chandrasekhara V, Chathadi KV, Decker GA, Early DS, Fisher DA, Foley K, Hwang JH, Jue TL, Lightdale JR, Pasha SF, Sharaf R, Shergill AK, Cash BD, and DeWitt JM
- Subjects
- Humans, Metaplasia diagnosis, Metaplasia therapy, Polyps diagnosis, Polyps therapy, Stomach pathology, Adenocarcinoma diagnosis, Adenocarcinoma therapy, Gastrointestinal Stromal Tumors diagnosis, Gastrointestinal Stromal Tumors therapy, Gastroscopy, Lymphoma, B-Cell, Marginal Zone diagnosis, Lymphoma, B-Cell, Marginal Zone therapy, Precancerous Conditions diagnosis, Precancerous Conditions therapy, Stomach Neoplasms diagnosis, Stomach Neoplasms therapy
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- 2015
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45. Corrigendum: Impact of Retroflexion Vs. Second Forward View Examination of the Right Colon on Adenoma Detection: A Comparison Study.
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Kushnir VM, Oh YS, Hollander T, Chen CH, Sayuk GS, Davidson N, Mullady D, Murad FM, Sharabash NM, Ruettgers E, Dassopoulos T, Easler JJ, Gyawali CP, Edmundowicz SA, and Early DS
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- 2015
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46. The role of endoscopy in inflammatory bowel disease.
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Shergill AK, Lightdale JR, Bruining DH, Acosta RD, Chandrasekhara V, Chathadi KV, Decker GA, Early DS, Evans JA, Fanelli RD, Fisher DA, Fonkalsrud L, Foley K, Hwang JH, Jue TL, Khashab MA, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf R, Cash BD, and DeWitt JM
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- Endoscopy, Gastrointestinal instrumentation, Humans, Severity of Illness Index, Endoscopy, Gastrointestinal methods, Inflammatory Bowel Diseases pathology, Inflammatory Bowel Diseases therapy
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- 2015
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47. Bowel preparation before colonoscopy.
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Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, and Acosta RD
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- Cathartics adverse effects, Drug Administration Schedule, Flavoring Agents, Humans, Laxatives administration & dosage, Cathartics administration & dosage, Colonoscopy methods, Colonoscopy standards
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- 2015
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48. The role of ERCP in benign diseases of the biliary tract.
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Chathadi KV, Chandrasekhara V, Acosta RD, Decker GA, Early DS, Eloubeidi MA, Evans JA, Faulx AL, Fanelli RD, Fisher DA, Foley K, Fonkalsrud L, Hwang JH, Jue TL, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf R, Shaukat A, Shergill AK, Wang A, Cash BD, and DeWitt JM
- Subjects
- Choledocholithiasis therapy, Constriction, Pathologic etiology, Humans, Sphincter of Oddi Dysfunction therapy, Stents, Bile Ducts pathology, Biliary Tract Diseases diagnosis, Biliary Tract Diseases therapy, Cholangiopancreatography, Endoscopic Retrograde, Constriction, Pathologic therapy
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- 2015
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49. Impact of retroflexion vs. second forward view examination of the right colon on adenoma detection: a comparison study.
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Kushnir VM, Oh YS, Hollander T, Chen CH, Sayuk GS, Davidson N, Mullady D, Murad FM, Sharabash NM, Ruettgers E, Dassopoulos T, Easler JJ, Gyawali CP, Edmundowicz SA, and Early DS
- Subjects
- Age Factors, Aged, Confidence Intervals, Early Detection of Cancer methods, Female, Humans, Logistic Models, Male, Middle Aged, Odds Ratio, Predictive Value of Tests, Adenoma diagnosis, Adenoma pathology, Colon, Ascending pathology, Colonic Neoplasms diagnosis, Colonic Neoplasms pathology, Colonoscopy methods
- Abstract
Objectives: Although screening colonoscopy is effective in preventing distal colon cancers, effectiveness in preventing right-sided colon cancers is less clear. Previous studies have reported that retroflexion in the right colon improves adenoma detection. We aimed to determine whether a second withdrawal from the right colon in retroflexion vs. forward view alone leads to the detection of additional adenomas., Methods: Patients undergoing screening or surveillance colonoscopy were invited to participate in a parallel, randomized, controlled trial at two centers. After cecal intubation, the colonoscope was withdrawn to the hepatic flexure, all visualized polyps removed, and endoscopist confidence recorded on a 5-point Likert scale. Patients were randomized to a second exam of the proximal colon in forward (FV) or retroflexion view (RV), and adenoma detection rates (ADRs) compared. Logistic regression analysis was used to evaluate predictors of identifying adenomas on the second withdrawal from the proximal colon., Results: A total of 850 patients (mean age 59.1±8.3 years, 59% female) were randomly assigned to FV (N=400) or RV (N=450). Retroflexion was successful in 93.5%. The ADR (46% FV and 47% RV) and numbers of adenomas per patient (0.9±1.4 FV and 1.1±2.1 RV) were similar (P=0.75 for both). At least one additional adenoma was detected on second withdrawal in similar proportions (10.5% FV and 7.5% RV, P=0.13). Predictors of identifying adenomas on the second withdrawal included older age (odds ratio (OR)=1.04, 95% confidence interval (CI)=1.01-1.08), adenomas seen on initial withdrawal (OR=2.8, 95% CI=1.7-4.7), and low endoscopist confidence in quality of first examination of the right colon (OR=4.8, 95% CI=1.9-12.1). There were no adverse events., Conclusions: Retroflexion in the right colon can be safely achieved in the majority of patients undergoing colonoscopy for colorectal cancer screening. Reexamination of the right colon in either retroflexed or forward view yielded similar, incremental ADRs. A second exam of the right colon should be strongly considered in patients who have adenomas discovered in the right colon, particularly when endoscopist confidence in the quality of initial examination is low.
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- 2015
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50. Resect and discard approach to colon polyps: real-world applicability among academic and community gastroenterologists.
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Vu HT, Sayuk GS, Hollander TG, Clebanoff J, Edmundowicz SA, Gyawali CP, Thyssen EP, Weinstock LB, and Early DS
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- Aged, Biopsy, Female, Gastroenterology standards, Humans, Male, Middle Aged, Missouri, Outpatient Clinics, Hospital, Predictive Value of Tests, Prospective Studies, Quality Indicators, Health Care, Risk Assessment, Risk Factors, Time Factors, Tumor Burden, Academic Medical Centers standards, Adenoma pathology, Adenoma surgery, Colectomy, Colonic Polyps pathology, Colonic Polyps surgery, Colonoscopy standards, Colorectal Neoplasms pathology, Colorectal Neoplasms surgery, Community Health Services standards, Gastroenterology methods
- Abstract
Background: "Resect and discard" (RD) is a new paradigm for management of diminutive polyps., Aim: To compare concordance of surveillance interval recommendations and diagnostic performance between RD and standard of care in a hospital outpatient department with both academic and community gastroenterologists., Methods: Prospective, observational study conducted at a single outpatient endoscopy center over 12 months. Patients with diminutive polyps on screening or surveillance colonoscopy were included. Histology predictions for all diminutive polyps (≤5 mm) were made based on endoscopic imaging. Concordance of recommended surveillance intervals and diagnostic performance of histology predictions were compared to histopathological review., Results: A total of 606 diminutive polyps were found in 315 patients (mean age 62.4 years, 49 % female). Histological prediction was made in 95.7 % of polyps (97.4 % of patients), with high confidence in 74.3 %. The concordance for surveillance intervals was 82.1 % compared to histopathological review and was similar between community and academic gastroenterologists (80.2 vs. 76.3 %, p = 0.38). Overall, sensitivity, specificity, and accuracy of histological predictions made with high confidence were 0.81, 0.36, and 77.1 %. Predictions made with narrow-band imaging (NBI) had lower accuracy (73.9 % with NBI vs. 82.5 % with high-definition white light (HWDL) only, p = 0.017) as well as lower prediction confidence (score of 7.6 with NBI vs. 8.6 with HDWL only, p < 0.001)., Conclusions: Our surveillance interval concordance was below the 90 % threshold deemed acceptable by the ASGE Preservation and Incorporation of Valuable Endoscopic Innovations statement. Diagnostic performance using optical imaging to predict histology was equal between community and academic endoscopists.
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- 2015
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