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1. Regret affects the choice between neoadjuvant therapy and upfront surgery for potentially resectable pancreatic cancer

Author

Cucchetti, A., Djulbegovic, B., Crippa, S., Hozo, I., Sbrancia, M., Tsalatsanis, A., Binda, C., Fabbri, C., Salvia, R., Falconi, M., Ercolani, G., Alfieri, Sergio, Amato, A., Amisano, M., Anderloni, A., Maestri, A., Coluccio, C., Brandi, G., Casadei-Gardini, A., Cennamo, V., Crino, S. F., Valle, R. D., De Angelis, C., Di Battista, M., Di Maio, M., Di Marco, M., Di Matteo, F., Di Mitri, R., Ettorre, G. M., Facciorusso, A., Farina, G., Ferrari, G., Fornaro, L., Frigerio, I., Frisone, D., Fuccio, L., Gardini, A., Garufi, C., Giampieri, R., Grazi, G. L., Jovine, E., Kauffmann, E., Langella, S., Larghi, Alberto Leonardo, Manno, M., Marciano, E., Marzioni, M., Merighi, A., Mutignani, M., Nardo, B., Niger, M., Palmisano, V., Partelli, S., Pinto, C., Piras, E., Rapposelli, I. G., Reni, M., Ricci, C., Rimassa, L., Siena, S., Spada, Cristiano, Sperti, E., Spezzaferro, M., Sposito, C., Tamberi, S., Troisi, R., Veneroni, L., Vivarelli, M., Zerbi, A., Alfieri S. (ORCID:0000-0002-0404-724X), Larghi A., Spada C. (ORCID:0000-0002-5692-0960), Cucchetti, A., Djulbegovic, B., Crippa, S., Hozo, I., Sbrancia, M., Tsalatsanis, A., Binda, C., Fabbri, C., Salvia, R., Falconi, M., Ercolani, G., Alfieri, Sergio, Amato, A., Amisano, M., Anderloni, A., Maestri, A., Coluccio, C., Brandi, G., Casadei-Gardini, A., Cennamo, V., Crino, S. F., Valle, R. D., De Angelis, C., Di Battista, M., Di Maio, M., Di Marco, M., Di Matteo, F., Di Mitri, R., Ettorre, G. M., Facciorusso, A., Farina, G., Ferrari, G., Fornaro, L., Frigerio, I., Frisone, D., Fuccio, L., Gardini, A., Garufi, C., Giampieri, R., Grazi, G. L., Jovine, E., Kauffmann, E., Langella, S., Larghi, Alberto Leonardo, Manno, M., Marciano, E., Marzioni, M., Merighi, A., Mutignani, M., Nardo, B., Niger, M., Palmisano, V., Partelli, S., Pinto, C., Piras, E., Rapposelli, I. G., Reni, M., Ricci, C., Rimassa, L., Siena, S., Spada, Cristiano, Sperti, E., Spezzaferro, M., Sposito, C., Tamberi, S., Troisi, R., Veneroni, L., Vivarelli, M., Zerbi, A., Alfieri S. (ORCID:0000-0002-0404-724X), Larghi A., and Spada C. (ORCID:0000-0002-5692-0960)

Abstract

Background: When treating potentially resectable pancreatic adenocarcinoma, therapeutic decisions are left to the sensibility of treating clinicians who, faced with a decision that post hoc can be proven wrong, may feel a sense of regret that they want to avoid. A regret-based decision model was applied to evaluate attitudes to-ward neoadjuvant therapy versus upfront surgery for potentially resectable pancreatic adenocarcinoma.Methods: Three clinical scenarios describing high-, intermediate-, and low-risk disease-specific mortality after upfront surgery were presented to 60 respondents (20 oncologists, 20 gastroenterologists, and 20 surgeons). Respondents were asked to report their regret of omission and commission regarding neo-adjuvant chemotherapy on a scale between 0 (no regret) and 100 (maximum regret). The threshold model and a multilevel mixed regression were applied to analyze respondents' attitudes toward neo-adjuvant therapy.Results: The lowest regret of omission was elicited in the low-risk scenario, and the highest regret in the high-risk scenario (P < .001). The regret of the commission was diametrically opposite to the regret of omission (P < .001). The disease-specific threshold mortality at which upfront surgery is favored over the neoadjuvant therapy progressively decreased from the low-risk to the high-risk scenarios (P <=.001). The nonsurgeons working in or with lower surgical volume centers (P = .010) and surgeons (P = .018) accepted higher disease-specific mortality after upfront surgery, which resulted in the lower likelihood of adopting neoadjuvant therapy.Conclusion: Regret drives decision making in the management of pancreatic adenocarcinoma. Being a surgeon or a specialist working in surgical centers with lower patient volumes reduces the likelihood of recommending neoadjuvant therapy.(c) 2023 Elsevier Inc. All rights reserved.

Published
2023

2. Azathioprine for prevention of clinical recurrence in Crohn's disease patients with severe endoscopic recurrence: an IG-IBD randomized double-blind trial

Author

Orlando, A, Mocciaro, F, Ventimiglia, M, Renna, S, Rispo, A, Scribano, M, Testa, A, Aratari, A, Bossa, F, Angelucci, E, Onali, S, Cappello, M, Giunta, M, Scimeca, D, Macaluso, F, Castiglione, F, Papi, C, Annese, V, Biancone, L, Kohn, A, Di Mitri, R, and Cottone, M

Subjects
Settore MED/12, Crohn Disease, Double-Blind Method, Recurrence, Azathioprine, Humans, Mesalamine
Abstract

The recurrence of Crohn's Disease after ileo-colonic resection is a crucial issue. Severe endoscopic lesions increase the risk of developing early symptoms. Prevention and treatment of post-operative Endoscopic Recurrence (ER) have been studied with conflicting results. We compare effi cacy of azathioprine (AZA) vs. high-dose 5-aminosalicylic acid (5-ASA) in preventing clinical recurrence and treating severe post-operative ER.We performed a 1-year multicenter randomized double-blind double-dummy trial. Primary end-points were endoscopic improvement and therapeutic failure (clinical recurrence or drug discontinuation due to lack of efficacy or adverse events) 12 months after randomization. We also performed a post-trial analysis on symptomatic and endoscopic outcomes 10 years after the beginning of the trial, with a median follow-up of 60 months.Therapeutic failure occurred in 8 patients (17.4%) within 12 months from randomization, with no significant difference between patients treated with 5-ASA (20.8%, 5 patients) and those with AZA (13.6%, 3 patients). Therapeutic failure was due to clinical recurrence in the 5-ASA group and to adverse events in the AZA group. Endoscopic improvement at 12 months was observed in 8 patients, 2 (11.8%) in the 5-ASA group and 6 (30%) in the AZA group. No serious adverse event was recorded. At the post-trial analysis (median follow-up 60 months), 47.8% (22/46) of patients experienced clinical recurrence: 54.2% (13/24) in the 5-ASA group and 40.9% (9/22) in the AZA group, p=0.546. Patients treated with AZA had lower risk of drug escalation. Clinical recurrence was associated with smoking (p=0.031) and previous surgery (p=0.003).Our trial indicates that there was no difference in terms of treatment failure between 5-ASA and AZA in patients with severe ER. The main limit of AZA is its less favorable safety profile.

Published
2020

3. Cancer Risk in Inflammatory Bowel Disease: A 6-Year Prospective Multicenter Nested Case-Control IG-IBD Study

Author

Biancone, L., Armuzzi, Alessandro, Scribano, M. L., Castiglione, F., D'Inca, R., Orlando, A., Papi, C., Daperno, M., Vecchi, M., Riegler, G., Fries, W., Alvisi, P., Meucci, G., Mocciaro, F., Rogai, F., Festa, S., Guidi, Luisa, Testa, A., Spina, L., Renna, S., Viola, A., Patturelli, M., Di Mitri, R., Frankovic, I., Calabrese, E., Petruzziello, C., De Cristofaro, E., Sena, G., Ruffa, A., Neri, B., Rossi, A., Armuzzi A. (ORCID:0000-0003-1572-0118), Guidi L. (ORCID:0000-0003-3320-7094), Biancone, L., Armuzzi, Alessandro, Scribano, M. L., Castiglione, F., D'Inca, R., Orlando, A., Papi, C., Daperno, M., Vecchi, M., Riegler, G., Fries, W., Alvisi, P., Meucci, G., Mocciaro, F., Rogai, F., Festa, S., Guidi, Luisa, Testa, A., Spina, L., Renna, S., Viola, A., Patturelli, M., Di Mitri, R., Frankovic, I., Calabrese, E., Petruzziello, C., De Cristofaro, E., Sena, G., Ruffa, A., Neri, B., Rossi, A., Armuzzi A. (ORCID:0000-0003-1572-0118), and Guidi L. (ORCID:0000-0003-3320-7094)

Abstract

Background: In a 6-year, multicenter, prospective nested case-control study, we aimed to evaluate risk factors for incident cancer in inflammatory bowel disease (IBD), when considering clinical characteristics of IBD and immunomodulator use. The secondary end point was to provide characterization of incident cancer types. Methods: All incident cases of cancer occurring in IBD patients from December 2011-2017 were prospectively recorded in 16 Italian Group for the Study of Inflammatory Bowel Disease units. Each of the IBD patients with a new diagnosis of cancer was matched with 2 IBD patients without cancer, according to IBD phenotype (ulcerative colitis [UC] vs Crohn's disease [CD]), age (±5 years), sex. Risk factors were assessed by multivariate logistic regression analysis. Results: Cancer occurred in 403 IBD patients: 204 CD (CD cases), 199 UC (UC cases). The study population included 1209 patients (403 IBD cases, 806 IBD controls). Cancer (n = 403) more frequently involved the digestive system (DS; 32%), followed by skin (14.9%), urinary tract (9.7%), lung (6.9%), genital tract (6.5%), breast (5.5%), thyroid (1.9%), lymphoma (2.7%, only in CD), adenocarcinoma of the small bowel (SBA; 3.9%, 15 CD, 1 pouch in UC), other cancers (15.9%). Among cancers of the DS, colorectal cancer (CRC) more frequently occurred in UC (29% vs 17%; P < 0.005), whereas SBA more frequently occurred in CD (13% vs 6.3% P = 0.039). In CD, perforating (B3) vs non-stricturing non-perforating (B1) behavior represented the only risk factor for any cancer (odds ratio [OR], 2.33; 95% confidence interval [CI], 1.33-4.11). In CD, risk factors for extracolonic cancer (ECC) were a B3 vs B1 and a stricturing (B2) vs B1 behavior (OR, 2.95; 95% CI, 1.62-5.43; OR, 1.79; 95% CI, 1.09-2.98). In UC, risk factors for ECC and for overall cancer were abdominal surgery for UC (OR, 4.63; 95% CI, 2.62-8.42; OR, 3.34; 95% CI, 1.88-5.92) and extensive vs distal UC (OR, 1.73; 95% CI, 1.10-2.75; OR, 1.99; 95% CI

Published
2020

4. Sicilian Network for Inflammatory Bowel Disease (SN-IBD). A propensity score-matched comparison of infliximab and adalimumab in naïve and non-naïve patients with Crohn’s disease

Author

Orlando, A., Macaluso, F., Fries, W., Privitera, A., Cappello, M., Siringo, S., Inserra, G., Magnano, A., Di Mitri, R., Belluardo, N., Scarpulla, G., Magrì, G., Trovatello, N., Carroccio, A., Genova, S., Bertolami, C., Vassallo, R., Ventimiglia, M., Renna, S., Orlando, R., Rizzuto, G., Cottone, M., and Orlando A., Macaluso F.S., Fries W., Privitera A.C., Cappello M., Siringo S., Inserra G., Magnano A., Di Mitri R., Belluardo N., Scarpulla G., Magrì G., Trovatello N., Carroccio A., Genova S., Bertolami C., Vassallo R., Ventimiglia M., Renna S., Orlando R., Rizzuto G, Cottone M.

Subjects
Sicilian Network, Inflammatory Bowel Disease, SN-IBD, Settore MED/09 - Medicina Interna
Abstract

Background: In the absence of head-to-head trials, there is an unmeet need to better understand the relative effectiveness of different biologics in inflammatory bowel disease (IBD). The Sicilian Network for Inflammatory Bowel Disease (SN-IBD) is a group composed by all Sicilian centres which continuously enter in a web-based software all clinical data of IBD patients treated with biologics. Methods: Data of all incident Crohn’s disease (CD) patients treated with infliximab (IFX) and adalimumab (ADA) from January 2013 to April 2017 were extracted from the cohort of SN-IBD. Patients were divided in biologic-naïve and non-naïve, and the two groups were analysed singularly. We used a one-to-two propensity score matching (1 IFX: 2 ADA) accounting for the main baseline characteristics in naïve patients, and a one-to-one propensity score matching (1 IFX: 1 ADA) in non-naïve. Results: Seven hundred and forty-seven naïve and 188 non-naïve patients were included. After propensity score matching, 453 naïve (IFX: 151; ADA: 302) and 100 non-naïve patients (total treatments: 122; IFX: 61; ADA: 61) were analysed. Among naïve patients, the rates of response/remission at 12 weeks for IFX and ADA were 80.1% and 81.1%,, respectively (adjusted OR 0.97, p = 0.923); over a median follow-up of 11.8 months, the rates of response/remission for IFX and ADA were 70.2% and 66.2%, respectively, without significant differences (adjusted OR 1.14, p = 0.401). Among non-naïve patients, the rates of response/remission at 12 weeks for IFX and ADA were 68.9% and 60.7%, respectively (adjusted OR 1.54, p = 0.320); over a median follow-up of 8.9 months, the rates of response/remission for IFX and ADA were 57.4% and 54.1%, respectively, without significant differences (adjusted OR 1.96, p = 0.297). Cox regression analysis showed no differences in risk of treatment failure between ADA and IFX, neither in naïve (adjusted HR 1.23, p = 0.381) nor in non-naïve patients (adjusted HR 1.23, p = 0.488). At multivariable conditional logistic regression analysis of naïve CD patients, upper GI involvement (OR 0.18, p = 0.038), previous surgery (OR 0.24, p = 0.003), and older age (OR 0.97, p = 0.036) were associated with lower clinical benefit at 12 weeks, while previous surgery was the only independent predictor of treatment failure at the end of follow-up (HR 2.13, p = 0.03). Mixed effect Cox analysis showed that non-naïve patients experiencing more than one previous line of treatment with biologics have a significant higher risk of treatment failure compared with those previously treated with one biologic only (HR 2.57, p = 0.002) Conclusions: In this large, propensity score matched, real-life, multicentre, cohort study of CD patients, there was no significant difference in the effectiveness of ADA and IFX. Both drugs showed a good efficacy.

Published
2018

5. The Sicilian network of biological therapy in inflammatory bowel disease: preliminary data on efficacy

Author

Orlando A., Macaluso F. S., Fries W., Privitera A. C., Cappello M., Siringo S., Inserra G., Magnano A., Di Mitri R., Belluardo N., Scarpulla G., Magrì G., Trovatello N., Carroccio A., Genova S., Calandruccio G., Vassallo R., Romano C., Pellegrino S., Citrano M., Accomando S., Ventimiglia M., Renna S., Orlando R., Rizzuto G., Vinci E., Cottone M., and Orlando A., Macaluso F.S., Fries W., Privitera A.C., Cappello M., Siringo S., Inserra G., Magnano A., Di Mitri R., Belluardo N., Scarpulla G., Magrì G., Trovatello N., Carroccio A., Genova S., Calandruccio G., Vassallo R., Romano C., Pellegrino S., Citrano M., Accomando S., Ventimiglia M., Renna S., Orlando R., Rizzuto G., Vinci E., Cottone M.

Subjects
Settore MED/09 - Medicina Interna, biological therapy, inflammatory bowel disease, Sicilian network
Abstract

Background: The monitoring of appropriateness, costs, and clinical outcomes of biological therapy in inflammatory bowel disease (IBD) is a relevant need. We aimed to evaluate all these issues in Sicily through a web based network of all prescribing centers. Methods: From January 2013, all IBD patients starting a biological agent (incident cases) or already on treatment (prevalent cases) were entered in a web based software. Herein we report data of incident cases about the efficacy of biological therapy after twelve weeks and one year of treatment. Results: From January 2013 to October 2016, 1475 patients were included. Incident cases were 1090. Considering that 16% of patients experienced more than one line of therapy, a total of 1351 treatments were reported. Adalimumab was used in 622 Crohn’s disease (CD) patients and in 83 ulcerative colitis (UC)/unclassified colitis patients. Infliximab was prescribed in 275 CD patients (80 biosimilars) and in 279 UC patients (50 biosimilars). Golimumab was used in 32 UC patients, while vedolizumab in 40 CD patients and in 20 UC patients. In patients with CD, after twelve weeks and one year of therapy, the rates of remission with adalimumab were 43.9% and 60.2%, respectively, and the rates of response 40.9% and 25.8%, while the rates of remission with infliximab originator were 46.2% and 50.0%, and the rates of response 40.9% and 32.9% (biosimilars: remission 31.0% and response 51.7% after 12 weeks; remission 45.5% and response 36.4% after one year). In UC, after twelve weeks and one year of therapy, the rates of remission with adalimumab were 43.3% and 57.1%, respectively, and the rates of response 36.7% and 19.0%; the rates of remission with infliximab originator were 41.6% and 48.4%, and the rates of response 35.6% and 32.3% (biosimilars: remission 30.0% and response 63.3% after 12 weeks; remission 20.0% and response 40.0% after one year); the rate of remission after 12 weeks of therapy with Golimumab was 22.2%, and the rate of response was 33.3%. After twelve weeks of therapy with Vedolizumab, 28.6% of CD patients were in remission and 32.0% had a response, while the rates of remission and response in UC patients were 33.3% and 22.0%, respectively. Multivariable logistic regression analysis showed that age >50 years was independently linked to lower rates of remission/response at 12 weeks in CD patients (OR 0.613, p=0.046). Conclusions: In one of the largest series of IBD patients on biological therapy reported to date, CD patients older than 50 years showed a higher rate of non response at 12 weeks of treatment. Efficacy of biosimilars was overall comparable to that reported for infliximab originator.

Published
2017

6. The sicilian network of biological therapy in inflammatory bowel disease: preliminary data from a prospective study on efficacy and safety

Author

Orlando A., Fries W., Privitera A., Cappello M., Siringo S., Inserra G., Magnano A., Di Mitri R., Belluardo N., Scarpulla G., Magrì G., Trovatello A., Carroccio A., Genova S., Calandruccio G., Vassallo R., Romano C, Magazzù G., Citrano M., Accomando S., Ventimiglia M., Renna S., Orlando R., Rizzuto G., Vinci E., Macaluso F. S., Cottone M., and Orlando A., Fries W., Privitera A., Cappello M., Siringo S., Inserra G., Magnano A., Di Mitri R., Belluardo N., Scarpulla G., Magrì G., Trovatello A., Carroccio A., Genova S., Calandruccio G., Vassallo R., Romano C, Magazzù G., Citrano M., Accomando S., Ventimiglia M., Renna S., Orlando R., Rizzuto G., Vinci E., Macaluso F.S., Cottone M.

Subjects
Settore MED/09 - Medicina Interna, biological therapy, inflammatory bowel disease, Sicilian network
Abstract

Background and aim: The monitoring of appropriateness and costs of biological therapy in Inflammatory bowel disease (IBD) is a relevant need. We aimed to evaluate appropriateness, efficacy and safety of biological therapy in IBD in Sicily through a web based network of prescribing centers. Material and methods: The Sicilian network for the monitoring of biological therapy in IBD is composed by a super Hub coordinator center and five Hub plus ten Spoke centers. From January 2013 all IBD patients starting a biological agent (incident cases) or already on treatment (prevalent cases) were entered in a web based software. Herein we report data on remission and response after twelve weeks of biological therapy, and side effects until the end of follow-up of incident cases. Results: From January 2013 to June 2016, 1475 patients were included. Complete data were available in 1338 cases (983 with Crohn’s disease [CD], 345 with ulcerative colitis [UC], and 10 with unclassified colitis). Incident cases were 956 (673 CD, 274 UC, and 9 unclassified colitis). Considering that 12% of patients experienced more than one line of therapy, a total of 1098 treatments were reported. Adalimumab was used in 543 CD patients, in 69 UC patients, and in 4 with unclassified colitis. Infliximab was prescribed in 221 CD patients (64 biosimilars), in 226 UC patients (41 biosimilars), and in 5 patients with unclassified colitis. Golimumab was prebscribed in 29 UC patients, and in 1 patient with unclassified colitis. After twelve weeks, the rate of response with Adalimumab was 46% and the rate of remission was 38% in CD, while the rate of response with Infliximab originator was 48% and the rate of remission 42% (biosimilars: 37% and 50%, respectively). In UC the rate of response with Adalimumab was 46% and the rate of remission was 38%, the rate of response with Infliximab was 41% and the rate of remission 45% (biosimilars: 25% and 64%, respectively), while the rate of response with Golimumab was 47% and the rate of remission was 27%. Overall, the rate of side effects was 17% (9.2% with Adalimumab, 20% with Infliximab originator, 15% with biosimilars, and 17% with Golimumab). Conclusions: In one of the largest series of IBD patients on biological therapy reported to date, the rates of remission and response after twelve weeks were comparable to data from literature, and similar between the different biologics. Efficacy and safety of biosimilars were analogous to those reported for infliximab originator.

Published
2017

7. The sicilian network for inflammatory bowel disease (SN-IBD): preliminary data on efficacy of biological therapy

Author

Orlando, A., Macaluso, F., Fries, W., Privitera, A., Cappello, M., Siringo, S., Inserra, G., Magnano, A., Di Mitri, R., Belluardo, N., Scarpulla, G., Magrì, G., Trovatello, A., Carroccio, A., Genova, S., Bertolami, C., Vassallo, R., Romano, C., Pellegrino, S., Citrano, M., Accomando, S., Ventimiglia, M., Renna, S., Orlando, R., Rizzuto, G., Vinci, E., Cottone, M., and Orlando A., Macaluso F.S., Fries W., Privitera A.C., Cappello M., Siringo S., Inserra G., Magnano A., Di Mitri R., Belluardo N., Scarpulla G., Magrì G., Trovatello A., Carroccio A., Genova S., Bertolami C., Vassallo R., Romano C., Pellegrino S., Citrano M., Accomando S., Ventimiglia M., Renna S., Orlando R., Rizzuto G., Vinci E., Cottone M.

Subjects
Settore MED/09 - Medicina Interna, Sicilian network, inflammatory bowel disease, SN-IBD
Abstract

Introduction: The monitoring of appropriateness, costs, and clinical outcomes of biological therapy in inflammatory bowel disease (IBD) is a relevant need. Aims & Methods: We aimed to evaluate all these issues in Sicily through a webbased network of all prescribing centers. The Sicilian Network for Inflammatory Bowel Disease (SN-IBD) is composed by a super Hub coordinator centre and five Hub plus ten Spoke centres. From January 2013, all IBD patients starting a biological agent (incident cases) or already on treatment (prevalent cases) were entered in a web based software. Herein we report data of incident cases about the efficacy of biological therapy after twelve weeks and one year of treatment. As clinical end-point, we set remission (corresponding to a Mayo Partial Score 52 for UC, and to a Harvey-Bradshaw Index 55 for CD), and response (reduction of Harvey-Bradshaw Index

Published
2017

8. Inflammatory Bowel Disease Phenotype as Risk Factor for Cancer in a Prospective Multicentre Nested Case-Control IG-IBD Study

Author

Biancone, L, Armuzzi, A, Scribano, Ml, D'Inca, R, Castiglione, F, Papi, C, Angelucci, E, Daperno, M, Mocciaro, F, Riegler, G, Fries, W, Meucci, G, Alvisi, P, Spina, L, Ardizzone, S, Petruzziello, C, Ruffa, A, Kohn, A, Vecchi, M, Guidi, L, Di Mitri, R, Renna, S, Emma, C, Rogai, F, Rossi, A, Orlando, A, Pallone, F, Italian Group for the study of Inflammatory Bowel, Disease., Biancone, Livia, Armuzzi, Alessandro, Scribano, Maria Lia, D'Inca, Renata, Castiglione, Fabiana, Papi, Claudio, Angelucci, Erika, Daperno, Marco, Mocciaro, Filippo, Riegler, Gabriele, Fries, Walter, Meucci, Gianmichele, Alvisi, Patrizia, Spina, Luisa, Ardizzone, Sandro, Petruzziello, Carmelina, Ruffa, Alessandra, Kohn, Anna, Vecchi, Maurizio, Guidi, Luisa, Di Mitri, Roberto, Renna, Sara, Emma, Calabrese, Rogai, Francesca, Rossi, Alessandra, Orlando, Ambrogio, and Pallone, Francesco

Subjects
Adult, Male, medicine.medical_specialty, Pancolitis, Adolescent, Colorectal cancer, phenotype, Settore MED/12 - GASTROENTEROLOGIA, cancer risk, Inflammatory bowel disease, Aged, Aged, 80 and over, Case-Control Studies, Female, Follow-Up Studies, Humans, Immunologic Factors, Incidence, Inflammatory Bowel Diseases, Logistic Models, Middle Aged, Multivariate Analysis, Neoplasms, Prospective Studies, Risk Factors, Young Adult, Phenotype, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, 80 and over, medicine, Risk factor, Prospective cohort study, business.industry, Settore MED/09 - MEDICINA INTERNA, Cancer, General Medicine, medicine.disease, Ulcerative colitis, 030220 oncology & carcinogenesis, Nested case-control study, 030211 gastroenterology & hepatology, medicine.symptom, business
Abstract

Background and Aims: Cancer risk in inflammatory bowel disease [IBD] is still debated. In a prospective, multicentre, nested case-control study, we aimed to characterise incident cases of cancer in IBD. The role of immunomodulators vs clinical characteristics of IBD as risk factors for cancer was also investigated. Materials and Methods: From January 2012 to December 2014, each IBD patient with incident cancer was matched with two IBD patients without cancer for: IBD type, gender, and age. Risk factors were assessed by multivariate regression analysis. Results: IBD patients considered numbered 44619: 21953 Crohn’s disease \[CD], 22666 ulcerative colitis [UC]. Cancer occurred in 174 patients: 99 CD [CD-K], 75 UC [UC-K]. Controls included 198 CD [CD-C], 150 UC [UC-C]. Cancer incidence in IBD was 3.9/1000, higher in CD (4.5/1000 [99/21,953]) than in UC (3.3/1000 [75/22,666]; p = 0.042). Cancers involved: digestive system [36.8%], skin [13.2%], urinary tract [12.1%], lung [8.6%], breast [8%], genital tract [6.9%], thyroid [4.6%], lymphoma [3.5%], others [6.3%]. In CD, penetrating behaviour and combined thiopurines and tumour necrosis factor alpha [TNFα] antagonists were risk factors for cancer overall: odds ratio [OR\] (95% confidence interval \[CI] 2.33 [1.01–5.47]); 1.97 [1.1–3.5]; and for extracolonic cancers 3.9 [1.56–10.1]; 2.15 [1.17–4.1], respectively. In UC, risk factors were pancolitis and disease-related surgery for cancer overall (OR: 2.52 [1.26–5.1]; 5.09 [1.73–17.1]); disease-related surgery for colorectal cancer [CRC\] (OR 3.6 [1.0–12]); and extensive and left-sided vs distal UC for extracolonic cancers (OR: 2.55 [1.15–5.9]; 2.6 [1.04–6.6]), respectively. Conclusions: In a multicentre study, penetrating CD and extensive UC were risk factors for cancer overall. Cancer incidence was higher in CD than in UC.

Published
2016

12. Colorectal cancer in patients with type 2 diabetes mellitus: a single-center experience

Author

Sinagra, E., Guarnotta, V., Raimondo, D., Filippo Mocciaro, Dolcimascolo, S., Rizzolo, C. A., Puccia, F., Maltese, N., Citarrella, R., Messina, M., Spada, M., Tomasello, G., Cappello, F., Leone, A., Rossi, F., Di Mitri, R., Morreale, G. C., Marasà, S., Midiri, M., Midiri, F., Sinagra, D., Sinagra,E, Guarnotta,V, Raimondo,D, Mocciaro,F, Dolcimascolo S, Rizzollo,CA, Puccia,F, Maltese,N, Citarrella,R, Messina,M, Spada,M, Tomasello,G, Cappello,F, Leone,A, Rossi,F, Di Mitri,R, Morreale,GC, Marasà,S, Midiri,M, Midiri,F, and Sinagra,D

Subjects
Male, Settore MED/12 - Gastroenterologia, Middle Aged, Risk Assessment, colorectal cancer, diabetes mellitu 2 type, Metformin, White People, Settore MED/18 - Chirurgia Generale, Sulfonylurea Compounds, Diabetes Mellitus, Type 2, Risk Factors, Case-Control Studies, Insulin Secretion, Humans, Hypoglycemic Agents, Insulin, Female, Colorectal Neoplasms, Aged, Retrospective Studies
Abstract

Type 2 diabetes mellitus (T2DM) is associated with an increased risk of colorectal cancer (CRC). The aim of the study is to evaluate the prevalence of CRC in a cohort of Caucasian patients with T2DM and the association with other variables previously known to be related with increased risk of CRC. We retrospectively evaluated the data of 741 consecutive Caucasian patients with T2DM who underwent colonoscopic screening in our tertiary referral center. A control cohort of 333 patients with thyroid disease was selected to evaluate the difference in the incidence of CRC. At a median follow-up of 132.5 months (range 33.3-175.7), 67 cases of cancer (prevalence 9%) occurred; among these, 14 cases of CRC were reported (prevalence 1.88%) among the diabetic patients, while only two case (one of these was a CRC) (overall prevalence 0.006%, prevalence of CRC 0.003%) occurred in the control group; the difference between the prevalence of CRC was statistically significant (chi-square 4.21, p=0.04). The median duration of T2DM to CRC diagnosis was 168 months (range 12-768). At the univariate analysis, older age (p=0.001, r 0.138) and diabetes duration (p=0.001, r 0.138) were related to higher risk of cancer, while metformin seems to be protective towards cancer (p=0.07, r -0.098). In the subset of patients with CRC, the age (RR = 2.25; 95% CI: 0.30 - 17.31; p less than 0.001), the diabetes duration (RR = 1.93; 95% CI: 0.25 – 14.77; p = 0.001) and the sulphonylureas treatment (RR = 2.33; 95% CI: 0.78 – 7.38; p = 0.007) were independently correlated with CRC. In our study, the prevalence of CRC in the cohort of patients with T2DM was higher compared to that from the National Tumor Register in 2010 (0.5%). Furthermore, we could speculate that sulphonylureas may play a role in CRC carcinogenesis impairing the physiological insulin secretion.

13. Persistence on Anti-Tumour Necrosis Factor Therapy in Older Patients with Inflammatory Bowel Disease Compared with Younger Patients: Data from the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD)

Author

Fabio Salvatore Macaluso, Gaetano Inserra, Marco Ventimiglia, Maria Cappello, Mario Cottone, Antonio Carroccio, Angela Alibrandi, Antonino Carlo Privitera, Walter Fries, Filippo Mocciaro, N. Belluardo, A. Magnano, Sara Renna, S. Siringo, S. Garufi, Serena Porcari, C. Ferracane, Ambrogio Orlando, Alessandro Vitello, C. Bertolami, Oriana Fidanza, Roberto Di Mitri, Anna Viola, G. Magrì, and Porcari S, Viola A, Orlando A, Privitera AC, Ferracane C, Cappello M, Vitello A, Siringo S, Inserra G, Magnano A, Mocciaro F, Di Mitri R, Belluardo N, Fidanza O, Garufi S, Magrì G, Bertolami C, Carroccio A, Macaluso FS, Renna S, Ventimiglia M, Alibrandi A, Cottone M, Fries W

Subjects
Adult, Male, medicine.medical_specialty, Settore MED/09 - Medicina Interna, Drug-Related Side Effects and Adverse Reactions, Kaplan-Meier Estimate, Anti-Tumour Necrosis Factor, Disease, Inflammatory bowel disease, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Internal medicine, medicine, Humans, Pharmacology (medical), Treatment Failure, 030212 general & internal medicine, Adverse effect, Aged, Retrospective Studies, Aged, 80 and over, Tumor Necrosis Factor-alpha, business.industry, Inflammatory Bowel Disease, Adalimumab, Age Factors, Antibodies, Monoclonal, Retrospective cohort study, Middle Aged, Inflammatory Bowel Diseases, medicine.disease, Ulcerative colitis, Infliximab, Sicilian Network for Inflammatory Bowel Diseases (SN-IBD), Withholding Treatment, Concomitant, Female, Geriatrics and Gerontology, business, 030217 neurology & neurosurgery, Cohort study
Abstract

BACKGROUND AND OBJECTIVE: Older people with inflammatory bowel disease (IBD) appear to have a lower response to anti-tumour necrosis factor (TNF) therapy, with more frequent complications than younger patients. The objective of this study was to assess persistence on therapy and the safety of anti-TNF therapy in older patients (aged ≥ 60 years). METHODS: We retrospectively reviewed the database of the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD), extracting data regarding IBD patients aged ≥ 60 years and controls

Published
2020
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14. Impact of biliary stents on the diagnostic accuracy of EUS-guided fine-needle biopsy of solid pancreatic head lesions: A multicenter study

Author

StefanoFrancesco Crinò, MariaCristina Conti Bellocchi, Filippo Antonini, Giampiero Macarri, Silvia Carrara, Laura Lamonaca, Roberto Di Mitri, Elisabetta Conte, Carlo Fabbri, Cecilia Binda, Andrew Ofosu, Enrico Gasparini, Chiara Turri, Caterina Stornello, Ciro Celsa, Alberto Larghi, Erminia Manfrin, Armando Gabbrielli, Antonio Facciorusso, Matteo Tacelli, Crino S., Conti Bellocchi M., Antonini F., MacArri G., Carrara S., Lamonaca L., Di Mitri R., Conte E., Fabbri C., Binda C., Ofosu A., Gasparini E., Turri C., Stornello C., Celsa C., Larghi A., Manfrin E., Gabbrielli A., Facciorusso A., and Tacelli M.

Subjects
endoscopic retrograde cholangiopancreatography, pancreatic cancer, Hepatology, fine-needle biopsy, Gastroenterology, Radiology, Nuclear Medicine and imaging, Original Article, fine-needle aspiration, biliary drainage
Abstract

Background and Objectives: There is no clear evidence of a negative impact of biliary stents on the diagnostic yield of EUS-guided fine-needle biopsy (EUS-FNB) for diagnosing pancreatic head lesions. We aimed to evaluate the association between the presence of biliary stents and the diagnostic accuracy of EUS-FNB. Materials and Methods: A multicenter retrospective study including all jaundiced patients secondary to pancreatic head masses was performed. Patients were divided into two groups according to the presence of a biliary stent placed before EUS-FNB. Pathological results were classified according to the Papanicolaou classification and compared against the final diagnosis. Diagnostic measures in the two groups were compared. Multivariate logistic regression analyses including potential factors affecting EUS-FNB accuracy were performed. Results: Overall, 842 patients were included, 495 (58.8%) without and 347 (41.2%) with biliary stent. A plastic or a metal stent was placed in 217 (62.5%) and 130 (37.5%) cases, respectively. Diagnostic sensitivity and accuracy were significantly higher in patients without biliary stent than in those with stent (91.9% and 92.1% vs. 85.9% and 86.4%, P = 0.010 At multivariate analyses, lesion size (odds ratio [OR]: 1.05, 95% confidence interval [CI]: 1.02–1.09, P = 0.01) and presence of biliary stent (OR: 0.51, 95% CI: 0.32–0.89, P = 0.01) were independently associated with diagnostic accuracy. In the subgroup of patients with biliary stent, the type of stent (plastic vs. metal) did not impact EUS-FNB yield, whereas the use of larger bore needles enhanced diagnostic accuracy (OR: 2.29, 95% CI: 1.28–4.12, P = 0.005). Conclusions: In this large retrospective study, an indwelling biliary stent negatively impacted the diagnostic accuracy of EUS-FNB. Preferably, EUS-FNB should precede endoscopic retrograde cholangiopancreatography, especially in the case of small tumors.

Published
2021

15. A Propensity Score-matched Comparison of Infliximab and Adalimumab in Tumour Necrosis Factor-α Inhibitor-naïve and Non-naïve Patients with Crohn's Disease: Real-Life Data from the Sicilian Network for Inflammatory Bowel Disease

Author

A.C. Privitera, Salvatore Genova, Michele Citrano, G. Magrì, S. Siringo, Maria Cappello, Antonio Carroccio, Mario Cottone, Fabio Salvatore Macaluso, Filippo Mocciaro, Giulia Rizzuto, A. Magnano, G. Scarpulla, Sara Renna, N. Belluardo, Ambrogio Orlando, Gaetano Inserra, Claudio Romano, C. Ferracane, Salvatore Accomando, C. Bertolami, Walter Fries, R. Vassallo, R. Orlando, Roberto Di Mitri, A. Trovatello, Serena Porcari, Marco Ventimiglia, MacAluso F.S., Fries W., Privitera A.C., Cappello M., Siringo S., Inserra G., Magnano A., Di Mitri R., Mocciaro F., Belluardo N., Scarpulla G., Magri G., Trovatello A., Carroccio A., Genova S., Bertolami C., Vassallo R., Romano C., Citrano M., Accomando S., Ventimiglia M., Renna S., Orlando R., Rizzuto G., Porcari S., Ferracane C., Cottone M., and Orlando A.

Subjects
0301 basic medicine, Adult, Male, medicine.medical_specialty, Inflammatory bowel disease, Gastroenterology, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Crohn Disease, Gastrointestinal Agents, Internal medicine, medicine, Adalimumab, Humans, Young adult, Sicily, propensity score, Crohn's disease, business.industry, Tumor Necrosis Factor-alpha, General Medicine, Odds ratio, medicine.disease, infliximab, Female, Infliximab, Propensity Score, Treatment Outcome, 030104 developmental biology, Cohort, Propensity score matching, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract

Background and aims There is an unmet need to better understand the effectiveness of different biologics in inflammatory bowel diseases. We aimed at performing a multicentre, real-life comparison of the effectiveness of infliximab [IFX] and adalimumab [ADA] in Crohn's disease [CD]. Methods Data of consecutive patients with CD treated with IFX and ADA from January 2013 to May 2017 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease. We used propensity score-matching accounting for the main baseline characteristics in TNF-α inhibitor-naive and non-naive patients. Results A total of 632 patients [735 total treatments] were included. Among naive patients, a clinical benefit [the sum of steroid-free remission plus clinical response] was achieved in 81.8% patients treated with ADA and in 77.6% patients treated with IFX (adjusted odds ratio [OR]: 1.23, 95% CI 0.63-2-44, p = 0.547] at 12 weeks; after 1 year, a clinical benefit was achieved in 69.2% of patients treated with ADA and in 64.5% patients treated with IFX [adjusted OR: 1.10, 95% CI 0.61-1.96, p = 0.766]. Among non-naive patients, a clinical benefit was achieved in 61.7% of patients treated with ADA and in 68.1% of patients treated with IFX [adjusted OR: 0.72, 95% CI 0.21-2.44, p = 0.600] at 12 weeks; after 1 year, a clinical benefit was achieved in 48.9% of patients treated with ADA and in 40.4% patients treated with IFX [adjusted OR: 1.23, 95% CI 0.54-2.86, p = 0.620]. Conclusions In this propensity score-matched comparison of ADA and IFX in CD, both drugs showed high rates of clinical benefit, without significant differences between them.

Published
2019

16. Novel lumen-apposing metal stent for the drainage of pancreatic fluid collections: An Italian multicentre experience

Author

Massimiliano Mutignani, Alberto Larghi, Sabrina Gloria Giulia Testoni, Carlo Fabbri, Edoardo Forti, Livia Archibugi, Ilaria Tarantino, Maria Chiara Petrone, Roberto Di Mitri, Paolo Giorgio Arcidiacono, Rita Conigliaro, Petrone, Mc, Archibugi, L, Forti, E, Conigliaro, R, Di Mitri, R, Tarantino, I, Fabbri, C, Larghi, A, Testoni, Sgg, Mutignani, M, and Arcidiacono, P. G.

Subjects
Endoscopic ultrasound, medicine.medical_specialty, medicine.diagnostic_test, business.industry, medicine.medical_treatment, Gastroenterology, Stent, Lumen (anatomy), Original Articles, medicine.disease, Surgery, 03 medical and health sciences, 0302 clinical medicine, Oncology, Pancreatic Fluid, 030220 oncology & carcinogenesis, Occlusion, medicine, Pancreatitis, 030211 gastroenterology & hepatology, Drainage, Adverse effect, business
Abstract

Background Endoscopic ultrasound (EUS)-guided drainage is the procedure of choice for pancreatic fluid collection (PFC) management. Recently developed lumen-apposing fully covered self-expandable metal stents (LAMSs) may facilitate drainage, especially of necrotic and complex PFCs. Objective To evaluate the feasibility and efficacy of a newly developed LAMS (Nagi, Taiwong Medical Co. Ltd, South Korea) in the drainage of PFCs. Methods Retrospective analysis of LAMS drainage of PFCs from seven centres. Patient demographic, EUS and radiological findings, PFCs aetiology, procedural technical and clinical success, and adverse events were evaluated. Results Sixty-seven patients with mean age 58.8 ± 14 years (68.7% males) were included in the analysis. Of these, 44 patients had pseudocyst (PP) and 23 patients had walled-off pancreatic necrosis (WOPN). Technical success was achieved in 98.5% of cases and clinical success in 94%. The adverse event rate was 24.2%, higher and mostly due to stent migration and occlusion in the WOPN group as compared to the PP group, despite the time to stent removal being significantly lower in the WOPN group. Conclusions PFC drainage using the Nagi stent is highly feasible and effective, with a relatively safe profile. Future studies enrolling more patients with complex PFCs are needed to clearly establish the role of this stent in PFC management.

Published
2018

17. Six year adalimumab efficacy in steroid-dependent Crohn's disease patients: A prospective single-center real life study

Author

Maria Cappello, Mario Cottone, Marco Affronti, Marta Mazza, Marco Giunta, Sara Renna, Filippo Mocciaro, Ambrogio Orlando, M. Mendolaro, Giulia Rizzuto, Emanuele Orlando, Mariangela Dimarco, Roberto Di Mitri, Antonio Craxì, Orlando A., Renna S., Mocciaro F., Cappello M., Giunta M., Mendolaro M., Mazza M., Rizzuto G., Orlando E., Affronti M., Dimarco M., Di Mitri R., Craxi A., and Cottone M.

Subjects
0301 basic medicine, Male, Anti-Inflammatory Agents, Kaplan-Meier Estimate, Single Center, Inflammatory bowel disease, 0302 clinical medicine, Maintenance therapy, Crohn Disease, Long term therapy, Prospective Studies, skin and connective tissue diseases, Prospective cohort study, Multivariate Analysi, Crohn's disease, Remission Induction, Gastroenterology, Middle Aged, Anti-Inflammatory Agent, Treatment Outcome, Italy, Cohort, 030211 gastroenterology & hepatology, Female, Steroids, Human, medicine.drug, musculoskeletal diseases, Adult, medicine.medical_specialty, Steroid dependency, Maintenance Chemotherapy, 03 medical and health sciences, Internal medicine, medicine, Adalimumab, Humans, Adverse effect, Steroid, Hepatology, business.industry, medicine.disease, Surgery, Prospective Studie, 030104 developmental biology, Multivariate Analysis, business
Abstract

Background Adalimumab is effective in the treatment of Crohn's disease. We have already reported data on the efficacy of adalimumab in 110 steroid-dependent patients. At the end of the study 90 patients (64.5%) maintained clinical remission. Aims To assess efficacy and safety of adalimumab after 6 years in patients of the original cohort who responded to treatment. Methods The present study is an extension of the published paper on 90/110 patients. We report results on clinical remission and safety of 6 year maintenance therapy with adalimumab. Results Of the original cohort 90 patients completed the study, 17 were lost to follow-up and 3 died. At the end of follow-up (74.16 ± 10.3 months) 37/90 patients (41%) maintained clinical remission. Of these, 32 (86%) continued adalimumab and 5 (13%) discontinued treatment due to clinical remission and mucosal healing. Of the remaining 53/90 patients, 47 (52%) discontinued adalimumab due to clinical failure and 6 (7%) to adverse events. We obtained endoscopy data in 31/32 patients in clinical remission continuing adalimumab: 11 (36%) did not improve, 6 (19%) worsened, 14 (45%) improved. At univariable analysis no variables were related to treatment outcome. Conclusions This “real life” prospective study shows that adalimumab is a long-term effective and safe maintenance treatment in steroid-dependent Crohn's disease patients.

Published
2016

18. Correction: Outcomes of lumen apposing metal stent placement in patients with surgically altered anatomy: Multicenter international experience.

Author

Mangiavillano B, Ramai D, Kahaleh M, Tyberg A, Shahid H, Sarkar A, Samanta J, Dhar J, Bronswijk M, Van der Merwe S, Kouanda A, Ji H, Dai SC, Deprez P, Vargas-Madrigal J, Vanella G, Leone R, Arcidiacono PG, Robles-Medranda C, Alcivar Vasquez J, Arevalo-Mora M, Fugazza A, Ko C, Morris J, Lisotti A, Fusaroli P, Dhaliwal A, Mutignani M, Forti E, Cottone I, Larghi A, Rizzatti G, Galasso D, Barbera C, Di Matteo FM, Stigliano S, Binda C, Fabbri C, Pham KD, Di Mitri R, Amata M, Crinó SF, Ofosu A, De Luca L, Al-Lehibi A, Auriemma F, Paduano D, Calabrese F, Gentile C, Hassan C, Repici A, and Facciorusso A

Abstract

[This corrects the article DOI: 10.1055/a-2411-1814.]., Competing Interests: Conflict of Interest Benedetto Mangiavillano has no conflict of interest regarding this paper but is consultant for Taewoong medical., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Published
2024
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19. Underwater Techniques in Gastrointestinal Endoscopy: Diving into the Depths.

Author

Sferrazza S, Calabrese G, Maselli R, Morais R, Facciorusso A, Mavrogenis G, Di Mitri R, Repici A, and Maida M

Abstract

The endoscopic resection of gastrointestinal tract lesions embraces different types of techniques, ranging from conventional polypectomy/endoscopic mucosal resection (EMR) to the field of third-space endoscopy, including endoscopic submucosal dissection (ESD), full-thickness resection and peroral endoscopic myotomy (POEM). Parallelly, the advent of underwater techniques has served as an add-on for both basic and advanced procedures, since its first report in 2012. We aimed to provide a comprehensive update on the state of the art about the feasibility of underwater basic and advanced techniques for GI endoscopy. Underwater EMR (U-EMR) has proved effective and safe in treating > 10 mm sessile or flat or all-size recurrent colonic lesions. Conversely, although data show good effectiveness and safety for <10 mm lesions, it is preferred when high-grade dysplasia is suspected, favouring cold snare polypectomy for all other cases. Moreover, promising data are emerging regarding the feasibility of U-ESD for difficult-to-resect colonic lesions. U-EMR represents a standard of care for treating < 25 mm superficial non-ampullary duodenal epithelial tumours. Data regarding oesophageal, gastric and ampullary lesions remains limited to small cohorts. Finally, using water immersion for POEM has shown a reduction in procedure time compared to the CO 2 insufflation technique for vessel coagulation, albeit in a single-centre experience. Based on these results, U-EMR has become a standard for treating intermediate-size colonic and non-ampullary duodenal lesions, as highlighted also in the European Society of Gastrointestinal Endoscopy guidelines. Promising results have been shown in third-space endoscopy studies, even though further prospective studies are awaited to standardise the technique for both ESD and POEM.

Published
2024
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20. Outcomes of lumen apposing metal stent placement in patients with surgically altered anatomy: Multicenter international experience.

Author

Mangiavillano B, Ramai D, Kahaleh M, Tyberg A, Shahid H, Sarkar A, Samanta J, Dhar J, Bronswijk M, Van der Merwe S, Kouanda A, Ji H, Dai SC, Deprez P, Vargas-Madrigal J, Vanella G, Roberto L, Arcidiacono PG, Robles-Medranda C, Alcivar Vasquez J, Arevalo-Mora M, Fugazza A, Ko C, Morris J, Lisotti A, Fusaroli P, Dhaliwal A, Mutignani M, Forti E, Cottone I, Larghi A, Rizzatti G, Galasso D, Barbera C, Di Matteo FM, Stigliano S, Binda C, Fabbri C, Pham KD, Di Mitri R, Amata M, Crinó SF, Ofosu A, De Luca L, Al-Lehibi A, Auriemma F, Paduano D, Calabrese F, Gentile C, Hassan C, Repici A, and Facciorusso A

Abstract

Background and study aims Although outcomes of lumen-apposing metal stents (LAMS) placement in native anatomy have been reported, data on LAMS placement in surgically altered anatomy (SAA) are sparse. We aimed to assess outcomes of LAMS placement in patients with SAA for different indications. Patients and methods This was an international, multicenter, retrospective, observational study at 25 tertiary care centers through November 2023. Consecutive patients with SAA who underwent LAMS placement were included. The primary outcome was technical success defined as correct placement of LAMS. Secondary outcomes were clinical success and safety. Results Two hundred and seventy patients (125 males; average age 61 ± 15 years) underwent LAMS placement with SAA. Procedures included EUS-directed transgastric ERCP (EDGE) and EUS-directed transenteric ERCP (EDEE) (n = 82), EUS-guided entero-enterostomy (n = 81), EUS-guided biliary drainage (n = 57), EUS-guided drainage of peri-pancreatic fluid collections (n = 48), and EUS-guided pancreaticogastrostomy (n = 2). Most cases utilized AXIOS stents (n = 255) compared with SPAXUS stents (n = 15). Overall, technical success was 98%, clinical success was 97%, and the adverse event (AE) rate was 12%. Using AGREE classification, five events were rated as Grade II, 21 events as Grade IIIa, and six events as IIIb. No difference in AEs were noted among stent types ( P = 0.52). Conclusions This study shows that placement of LAMS is associated with high technical and clinical success rates in patients with SAA. However, the rate of AEs is noteworthy, and thus, these procedures should be performed by expert endoscopists at tertiary centers., Competing Interests: Conflict of Interest Benedetto Mangiavillano has no conflict of interest regarding this paper but is consultant for Taewoong medical., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Published
2024
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22. The Derivation and External Validation of a Fibrosis Risk Model for Colorectal Tumours Undergoing Endoscopic Submucosal Dissection.

Author

Sferrazza S, Maida M, Calabrese G, Facciorusso A, Fuccio L, Frazzoni L, Maselli R, Repici A, Di Mitri R, and Santos-Antunes J

Abstract

Background: Endoscopic submucosal dissection (ESD) is an advanced technique that can become more challenging in the presence of submucosal fibrosis. Predicting the grade of fibrosis is important in order to identify technically difficult ESD. Aims and Methods: Our study aimed to derive and validate a prediction model to determine the preoperative degree of submucosal fibrosis in colorectal tumours undergoing ESD. A predictive model was developed to derive the probability of an increasing submucosal fibrosis in the derivation cohort and then externally validated. Results: 309 patients (age: 68 ± 10.9 years) underwent colorectal ESD between January 2016 and June 2020. F0, F1, and F2 fibroses were reported in 196 (63.4%), 70 (22.6%), and 43 (13.9%) cases, respectively. R0 resection was found in 266 (87%) lesions. At multivariable analysis in the derivation cohort, lesion morphology (OR = 0.37 and CI = 0.14-0.97 for LST-NG vs. 0-Is; OR = 0.29 and CI = 0.1-0.87 for the LST mixed type vs. 0-Is; and OR = 0.32 and CI = 0.1-1.03 for LST-G vs. 0-Is) and increasing size (OR = 1.02 and CI = 1.01-1.04 for a 1 mm increase) were significantly associated with an increasing degree of fibrosis. The model had fair discriminating ability in the derivation group (AUROC = 0.61 and CI = 0.52-0.69 for F1-F2 vs. F0 fibroses; AUROC = 0.61 and CI = 0.45-0.77 for F2 vs. F0-F1 fibroses) and in the validation group (AUROC = 0.71 and CI = 0.59-0.83 for F1-F2 vs. F0 fibroses; AUROC = 0.65 and CI = 0.52-0.77 for F2 vs. F0-F1 fibroses). Conclusions : Our findings introduce a new tool for the stratification of ESD technical difficulty based on lesion size and morphological characteristics which could become crucial during the procedure's planning process.

Published
2024
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23. Common bile duct size in malignant distal obstruction and lumen-apposing metal stents: a multicenter prospective study.

Author

Rimbaş M, Anderloni A, Napoléon B, Seicean A, Forti E, Crinò SF, Tarantino I, Arcidiacono PG, Fabbri C, Rizzatti G, Amato A, Voiosu T, Fugazza A, Moșteanu O, Ginès À, de Nucci G, Fusaroli P, Nguyen NQ, Di Mitri R, Minelli Grazioli L, Mutignani M, Archibugi L, Binda C, Cominardi A, Barbera C, Fernández-Esparrach G, Palazzo L, Palazzo M, Poley JW, Spada C, Valerii G, Itoi T, Matsunami Y, Mateescu RB, Băicuș C, Costamagna G, and Larghi A

Abstract

Background and study aims  Feasibility of EUS-guided choledochoduodenostomy (EUS-CDS) using available lumen-apposing stents (LAMS) is limited by the size of the common bile duct (CBD) (≤ 12 mm, cut-off for experts; 15 mm, cut-off for non-experts). We aimed to assess the prevalence and predictive factors associated with CBD size ≥ 12 and 15 mm in naïve patients with malignant distal biliary obstruction (MDBO). Patients and methods  This was a prospective cohort study involving 22 centers with assessment of CBD diameter and subjective feasibility of the EUS-CDS performance in naïve jaundiced patients undergoing EUS evaluation for MDBO. Results  A total of 491 patients (mean age 69 ± 12 years) with mean serum bilirubin of 12.7 ± 6.6 mg/dL entered the final analysis. Dilation of the CBD ≥ 12 and 15 mm was detected in 78.8 % and 51.9 % of cases, respectively. Subjective feasibility of EUS-CDS was expressed by endosonographers in 91.2 % for a CBD ≥ 12 mm and in 96.5 % for a CBD ≥ 15 mm. On multivariate analysis, age ( P  < 0.01) and bilirubin level ( P  ≤ 0.001) were the only factors associated with both CBD dilation ≥ 12 and ≥ 15 mm. These variables were poorly associated with the extent of duct dilation; however, based on them a prediction model could be constructed that satisfactorily predicted CBD size ≥ 12 mm in patients at least 70 years and a bilirubin level ≥ 7 mg/dL. Conclusions  Our study showed that at presentation in a large cohort of patients with MDBO, EUS-CDS can be potentially performed in three quarters to half of cases by expert and less experienced endosonographers, respectively. Dedicated stents or devices with different designs able to overcome the limitations of existing electrocautery-enhanced LAMS for EUS-CDS are needed., Competing Interests: Competing interests Dr. Anderloni is a consultant for Boston Scientific, Olympus Medical and Medtronic. Dr. Fabbri is a consultant for Boston Scientific. Dr. Napoleon has held supported teaching sessions and had research collaboration with Boston Scientific. Dr. Poley served as a consultant for and received speaker and travel fees from Boston Scientific, Cook Endoscopy, and Pentax. Dr. Mutignani had a research collaboration with Boston Scientific. Dr. Palazzo is a consultant for Boston Scientific. Dr. Itoi is a speaker for Boston Scientific. Dr. Costamagna received research support from Cook Endoscopy and he currently is a member of Advisory Committees or review panels for Olympus Medical and Boston Scientific. Dr. Larghi received educational fees from Boston Scientific and Pentax., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Published
2021
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24. Impact of biliary stents on the diagnostic accuracy of EUS-guided fine-needle biopsy of solid pancreatic head lesions: A multicenter study.

Author

Crinò SF, Conti Bellocchi MC, Antonini F, Macarri G, Carrara S, Lamonaca L, Di Mitri R, Conte E, Fabbri C, Binda C, Ofosu A, Gasparini E, Turri C, Stornello C, Celsa C, Larghi A, Manfrin E, Gabbrielli A, Facciorusso A, and Tacelli M

Abstract

Background and Objectives: There is no clear evidence of a negative impact of biliary stents on the diagnostic yield of EUS-guided fine-needle biopsy (EUS-FNB) for diagnosing pancreatic head lesions. We aimed to evaluate the association between the presence of biliary stents and the diagnostic accuracy of EUS-FNB., Materials and Methods: A multicenter retrospective study including all jaundiced patients secondary to pancreatic head masses was performed. Patients were divided into two groups according to the presence of a biliary stent placed before EUS-FNB. Pathological results were classified according to the Papanicolaou classification and compared against the final diagnosis. Diagnostic measures in the two groups were compared. Multivariate logistic regression analyses including potential factors affecting EUS-FNB accuracy were performed., Results: Overall, 842 patients were included, 495 (58.8%) without and 347 (41.2%) with biliary stent. A plastic or a metal stent was placed in 217 (62.5%) and 130 (37.5%) cases, respectively. Diagnostic sensitivity and accuracy were significantly higher in patients without biliary stent than in those with stent (91.9% and 92.1% vs. 85.9% and 86.4%, P = 0.010 At multivariate analyses, lesion size (odds ratio [OR]: 1.05, 95% confidence interval [CI]: 1.02-1.09, P = 0.01) and presence of biliary stent (OR: 0.51, 95% CI: 0.32-0.89, P = 0.01) were independently associated with diagnostic accuracy. In the subgroup of patients with biliary stent, the type of stent (plastic vs. metal) did not impact EUS-FNB yield, whereas the use of larger bore needles enhanced diagnostic accuracy (OR: 2.29, 95% CI: 1.28-4.12, P = 0.005)., Conclusions: In this large retrospective study, an indwelling biliary stent negatively impacted the diagnostic accuracy of EUS-FNB. Preferably, EUS-FNB should precede endoscopic retrograde cholangiopancreatography, especially in the case of small tumors., Competing Interests: None

Published
2021
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25. Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial.

Author

Crinò SF, Di Mitri R, Nguyen NQ, Tarantino I, de Nucci G, Deprez PH, Carrara S, Kitano M, Shami VM, Fernández-Esparrach G, Poley JW, Baldaque-Silva F, Itoi T, Manfrin E, Bernardoni L, Gabbrielli A, Conte E, Unti E, Naidu J, Ruszkiewicz A, Amata M, Liotta R, Manes G, Di Nuovo F, Borbath I, Komuta M, Lamonaca L, Rahal D, Hatamaru K, Itonaga M, Rizzatti G, Costamagna G, Inzani F, Curatolo M, Strand DS, Wang AY, Ginès À, Sendino O, Signoretti M, van Driel LMJW, Dolapcsiev K, Matsunami Y, van der Merwe S, van Malenstein H, Locatelli F, Correale L, Scarpa A, and Larghi A

Subjects
Aged, Female, Humans, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Reproducibility of Results, Endoscopic Ultrasound-Guided Fine Needle Aspiration instrumentation, Pancreatic Neoplasms pathology, Rapid On-site Evaluation
Abstract

Background and Aims: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE., Methods: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time., Results: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, -1.1% to 3.1%; noninferiority P < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001)., Conclusions: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.)., (Copyright © 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Published
2021
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29. Novel lumen-apposing metal stent for the drainage of pancreatic fluid collections: An Italian multicentre experience.

Author

Petrone MC, Archibugi L, Forti E, Conigliaro R, Di Mitri R, Tarantino I, Fabbri C, Larghi A, Testoni SGG, Mutignani M, and Arcidiacono PG

Abstract

Background: Endoscopic ultrasound (EUS)-guided drainage is the procedure of choice for pancreatic fluid collection (PFC) management. Recently developed lumen-apposing fully covered self-expandable metal stents (LAMSs) may facilitate drainage, especially of necrotic and complex PFCs., Objective: To evaluate the feasibility and efficacy of a newly developed LAMS (Nagi, Taiwong Medical Co. Ltd, South Korea) in the drainage of PFCs., Methods: Retrospective analysis of LAMS drainage of PFCs from seven centres. Patient demographic, EUS and radiological findings, PFCs aetiology, procedural technical and clinical success, and adverse events were evaluated., Results: Sixty-seven patients with mean age 58.8 ± 14 years (68.7% males) were included in the analysis. Of these, 44 patients had pseudocyst (PP) and 23 patients had walled-off pancreatic necrosis (WOPN). Technical success was achieved in 98.5% of cases and clinical success in 94%. The adverse event rate was 24.2%, higher and mostly due to stent migration and occlusion in the WOPN group as compared to the PP group, despite the time to stent removal being significantly lower in the WOPN group., Conclusions: PFC drainage using the Nagi stent is highly feasible and effective, with a relatively safe profile. Future studies enrolling more patients with complex PFCs are needed to clearly establish the role of this stent in PFC management.

Published
2018
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30. γδ cells and tumor microenvironment: A helpful or a dangerous liason?

Author

Lo Presti E, Di Mitri R, Pizzolato G, Mocciaro F, Dieli F, and Meraviglia S

Subjects
Humans, Neoplasms metabolism, Neoplasms pathology, Receptors, Antigen, T-Cell, gamma-delta metabolism, Neoplasms immunology, Receptors, Antigen, T-Cell, gamma-delta immunology, T-Lymphocytes immunology, Tumor Microenvironment immunology
Abstract

γδ T cells are a subset of T lymphocytes that have been implicated in immunosurveillance against infections and tumors. γδ T cells are endowed with antitumor activities, and hence several γδ T cell-based small-scale clinical trials have been conducted either by in vivo activation by intravenous administration of aminobiphosphonates or by adoptive transfer of in vitro expanded γδ T cells. Although both these strategies have yielded promising results, there are a number of limitations associated with each of them which, if overcome may help to further improve efficacy. One of the most important limits is the possible polarization of tumor-infiltrating γδ T cells toward different γδ T cells population with functional activities that help the progression and spread of the tumor. Here, we review the modalities and the possible mechanisms involved in the polarization of tumor-infiltrating γδ T cells upon interaction with several components of the tumor microenvironment and discuss their implications for the manipulation of γδ T cells in cancer immunotherapy., (©2017 Society for Leukocyte Biology.)

Published
2018
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31. Single-operator holmium laser lithotripsy under direct peroral cholangioscopy using an ultra-slim upper endoscope in a patient with a large stone in the common bile duct.

Author

Di Mitri R and Mocciaro F

Subjects
Aged, 80 and over, Endoscopy, Digestive System instrumentation, Equipment Design, Female, Humans, Mouth surgery, Natural Orifice Endoscopic Surgery instrumentation, Treatment Outcome, Endoscopes, Endoscopy, Digestive System methods, Gallstones surgery, Lasers, Solid-State therapeutic use, Lithotripsy, Laser methods, Natural Orifice Endoscopic Surgery methods
Abstract

In patients with complicated stones (e.g., large stones) in the common bile duct (CBD), advanced treatment modalities are generally needed. Here we present an interesting case of a large CBD stone treated with holmium laser lithotripsy, which was performed under direct peroral cholangioscopy using an ultra-slim endoscope. An 86-year-old woman underwent endoscopic retrograde cholangiopancreatography for a symptomatic large CBD stone. After the failure of sphincterotomy, balloon sphincteroplasty, and mechanical and extracorporeal shock wave lithotripsy, we attempted to fragment the stone by peroral cholangioscopy using the holmium laser system through the operating channel of an ultra-slim endoscope. No complication was observed at the end of this procedure. Thus, holmium laser lithotripsy under direct peroral cholangioscopy performed using an ultra-slim endoscope is a feasible and safe endoscopic method for removing large CBD stones.

Published
2017
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32. Colorectal cancer in patients with type 2 diabetes mellitus: a single-center experience.

Author

Sinagra E, Guarnotta V, Raimondo D, Mocciaro F, Dolcimascolo S, Rizzolo CA, Puccia F, Maltese N, Citarrella R, Messina M, Spada M, Tomasello G, Cappello F, Leone A, Rossi F, Di Mitri R, Morreale GC, Marasà S, Midiri M, Midiri F, and Sinagra D

Subjects
Aged, Case-Control Studies, Colorectal Neoplasms blood, Colorectal Neoplasms complications, Colorectal Neoplasms drug therapy, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 drug therapy, Female, Humans, Insulin metabolism, Insulin Secretion, Male, Metformin therapeutic use, Middle Aged, Retrospective Studies, Risk Assessment, Risk Factors, White People, Colorectal Neoplasms diagnosis, Diabetes Mellitus, Type 2 diagnosis, Hypoglycemic Agents therapeutic use, Sulfonylurea Compounds adverse effects
Abstract

Type 2 diabetes mellitus (T2DM) is associated with an increased risk of colorectal cancer (CRC). The aim of the study is to evaluate the prevalence of CRC in a cohort of Caucasian patients with T2DM and the association with other variables previously known to be related with increased risk of CRC. We retrospectively evaluated the data of 741 consecutive Caucasian patients with T2DM who underwent colonoscopic screening in our tertiary referral center. A control cohort of 333 patients with thyroid disease was selected to evaluate the difference in the incidence of CRC. At a median follow-up of 132.5 months (range 33.3-175.7), 67 cases of cancer (prevalence 9%) occurred; among these, 14 cases of CRC were reported (prevalence 1.88%) among the diabetic patients, while only two case (one of these was a CRC) (overall prevalence 0.006%, prevalence of CRC 0.003%) occurred in the control group; the difference between the prevalence of CRC was statistically significant (chi-square 4.21, p=0.04). The median duration of T2DM to CRC diagnosis was 168 months (range 12-768). At the univariate analysis, older age (p=0.001, r 0.138) and diabetes duration (p=0.001, r 0.138) were related to higher risk of cancer, while metformin seems to be protective towards cancer (p=0.07, r -0.098). In the subset of patients with CRC, the age (RR = 2.25; 95% CI: 0.30 - 17.31; p less than 0.001), the diabetes duration (RR = 1.93; 95% CI: 0.25 – 14.77; p = 0.001) and the sulphonylureas treatment (RR = 2.33; 95% CI: 0.78 – 7.38; p = 0.007) were independently correlated with CRC. In our study, the prevalence of CRC in the cohort of patients with T2DM was higher compared to that from the National Tumor Register in 2010 (0.5%). Furthermore, we could speculate that sulphonylureas may play a role in CRC carcinogenesis impairing the physiological insulin secretion.

Published
2017

33. Efficacy and safety of endoscopic papillary balloon dilation for the removal of bile duct stones: Data from a "real-life" multicenter study on Dilation-Assisted Stone Extraction.

Author

Di Mitri R, Mocciaro F, Pallio S, Pecoraro GM, Tortora A, Zulli C, Attardo S, and Maurano A

Abstract

Aim: To report data on Dilation-Assisted Stone Extraction (DASE) use in clinical practice and its efficacy and safety trough three Italian referral centers for biliopancreatic diseases treatment., Methods: From January 2011 to December 2015 we collected data on 120 patients treated with DASE. Technical success was obtained when the endoscopist was able to place the balloon trough the papilla inflating the balloon until the final diameter for an adequate time (at least 30 s). Clinical success was obtained after complete stone removal (no remaining stones were visible at the cholangiogram)., Results: Forty-nine male (40.8%) and 71 female (59%) were enrolled. The mean age was 67.8 years ± 15.7. The mean common bile duct (CBD) dilation was 19.2 mm ± 3.9 and the mean size of stones 15.8 ± 2.9. DASE was applied as first approach in 38% (62% after initial failure of stones extraction). Technical and clinical success was of 91% and 87% respectively. In those in which DASE failed alternative treatment were adopted. After DASE 18% of patients experienced a complication (bleeding 9%, pancreatitis 8%, perforation 0.8%). At univariable analysis, elective endoscopic retrograde cholangiopancreatography ( P = 0.031), DASE as first approach ( P = 0.032), and cannulation of major papilla followed by guidewire insertion ( P = 0.004) were related to low risk of complications. Pre-cut was related to an increased risk of complications ( P = 0.01)., Conclusion: DASE allowed a higher first-session success rate and can be consider a valid alternative to endoscopic sphincterotomy not only for bigger CBD stones., Competing Interests: Conflict-of-interest statement: We have no financial relationships to disclose.

Published
2016
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35. Over-the-scope clips in the treatment of gastrointestinal tract iatrogenic perforation: A multicenter retrospective study and a classification of gastrointestinal tract perforations.

Author

Mangiavillano B, Caruso A, Manta R, Di Mitri R, Arezzo A, Pagano N, Galloro G, Mocciaro F, Mutignani M, Luigiano C, Antonucci E, Conigliaro R, and Masci E

Abstract

Aim: To determine the outcome of the management of iatrogenic gastrointestinal tract perforations treated by over-the-scope clip (OTSC) placement., Methods: We retrospectively enrolled 20 patients (13 female and 7 male; mean age: 70.6 ± 9.8 years) in eight high-volume tertiary referral centers with upper or lower iatrogenic gastrointestinal tract perforation treated by OTSC placement. Gastrointestinal tract perforation could be with oval-shape or with round-shape. Oval-shape perforations were closed by OTSC only by suction and the round-shape by the "twin-grasper" plus suction., Results: Main perforation diameter was 10.1 ± 4.3 mm (range 3-18 mm). The technical success rate was 100% (20/20 patients) and the clinical success rate was 90% (18/20 patients). Two patients (10%) who did not have complete sealing of the defect underwent surgery. Based upon our observations we propose two types of perforation: Round-shape "type-1 perforation" and oval-shape "type-2 perforation". Eight (40%) out of the 20 patients had a type-1 perforation and 12 patients a type-2 (60%)., Conclusion: OTSC placement should be attempted after perforation occurring during diagnostic or therapeutic endoscopy. A failed closure attempt does not impair subsequent surgical treatment.

Published
2016
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36. Y-shaped bilateral self-expandable metallic stent placement for malignant hilar biliary obstruction: data from a referral center for palliative care.

Author

Di Mitri R and Mocciaro F

Subjects
Aged, Bile Duct Neoplasms diagnosis, Female, Humans, Male, Middle Aged, Treatment Outcome, Bile Duct Neoplasms complications, Cholestasis etiology, Cholestasis therapy, Palliative Care, Stents adverse effects
Abstract

Background and Aim: Malignant hilar strictures are a clinical challenge because of the current therapeutic approach and the poor prognosis. In recent years, self-expandable metallic stents have proven more effective than plastic stents for palliation of malignant hilar strictures, with the bilateral stent-in-stent technique registering a high success rate. We report our experience with Y-shaped endoscopic self-expandable metallic stents placement for treatment of advanced malignant hilar strictures., Methods: From April 2009 to August 2012, we prospectively collected data on patients treated with Y-shaped SEMS placement for advanced malignant hilar carcinoma. Data on technical success, clinical success, and complications were collected., Results: Twenty patients (9 males) were treated (mean age 64.2 ± 15.3 years). The grade of malignant hilar strictures according to the Bismuth classification was II in 5 patients (25%), IIIa in 1 (5%), and IV in 14 (70%). The mean bilirubin level was 14.7 ± 4.9 mg/dL. Technical success was achieved in all patients, with a significant reduction in bilirubin levels (2.9 ± 1.7 mg/dL). One patient experienced cholangitis as early complication, while in 2 patients stent ingrowth was observed. No stents migration was recorded. There was no procedure-related mortality. At the end of the follow-up (7.1 ± 3.1 months), 13 of the 20 patients (65%) had died., Conclusions: Our experience confirms endoscopic bilateral self-expandable metallic stents placement with stent-in-stent technique (Y-shaped configuration) as a feasible, effective, and safe procedure for palliation of unresectable malignant hilar strictures.

Published
2014
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37. The new nitinol conformable self-expandable metal stents for malignant colonic obstruction: a pilot experience as bridge to surgery treatment.

Author

Di Mitri R and Mocciaro F

Subjects
Aged, Alloys administration & dosage, Colonic Neoplasms diagnosis, Female, Humans, Intestinal Obstruction diagnosis, Male, Metals administration & dosage, Middle Aged, Pilot Projects, Prospective Studies, Treatment Outcome, Alloys chemistry, Colonic Neoplasms surgery, Intestinal Obstruction surgery, Metals chemistry, Prosthesis Design trends, Stents
Abstract

Introduction: Self-expandable metal stents (SEMS) are a nonsurgical option for treatment of malignant colorectal obstruction also as a bridge to surgery approach. The new nitinol conformable stent has improved clinical outcomes in these kinds of patients. We report a pilot experience with nitinol conformable SEMS placement as bridge to surgery treatment in patients with colorectal obstruction., Materials and Methods: Between April and August 2012, we collected data on colonic nitinol conformable SEMS placement in a cohort of consecutive symptomatic patients, with malignant colorectal obstruction, who were treated as a bridge to surgery. Technical success, clinical success, and adverse events were recorded., Results: Ten patients (7 male (70%)), with a mean age of 69.2±10.1, were evaluated. The mean length of the stenosis was 3.6±0.6 cm. Five patients (50%) were treated on an emergency basis. The median time from stent placement to surgery was 16 days (interquartile range 7-21). Technical and clinical success was achieved in all patients with a significant early improvement of symptoms. No adverse events due to the SEMS placement were observed., Conclusion: This pilot study confirmed the important role of nitinol conformable SEMS as a bridge to surgery option in the treatment of symptomatic malignant colorectal obstruction.

Published
2014
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38. Endovenous laser treatment of the small saphenous vein.

Author

Kontothanassis D, Di Mitri R, Ferrari Ruffino S, Zambrini E, Camporese G, Gerard JL, and Labropoulos N

Subjects
Adult, Aged, Aged, 80 and over, Ecchymosis etiology, Feasibility Studies, France, Humans, Italy, Middle Aged, New York, Paresthesia etiology, Phlebitis etiology, Prospective Studies, Saphenous Vein diagnostic imaging, Sclerotherapy, Thrombosis etiology, Time Factors, Treatment Outcome, Ultrasonography, Doppler, Duplex, Ultrasonography, Interventional, Venous Insufficiency diagnostic imaging, Young Adult, Laser Therapy adverse effects, Saphenous Vein surgery, Venous Insufficiency surgery
Abstract

Purpose: Endovenous laser treatment is a minimally invasive technique for ablation of the incompetent great (GSV) and small saphenous vein (SSV). Compared with the GSV, fewer data are available on SSV laser ablation and are not validated. This multicenter prospective study evaluated the feasibility, safety, and efficacy of endovenous laser ablation to treat SSVs., Methods: Between January 2003 and January 2007, 204 patients (229 limbs) with CVD and incompetent SSVs (evaluated by the CEAP classification) who were eligible for surgery underwent consecutive laser ablation procedures. Many required additional treatment for varicose tributaries and perforator veins with phlebectomy and foam sclerotherapy, Energy was delivered to the vein wall by a 600-microm optical fiber using 810-nm or 980-nm diode laser. Ablations were performed with duplex ultrasound (DU) guidance and tumescent anesthesia. Follow-up was with clinical examination and DU imaging., Results: DU imaging showed immediate occlusion of the SSV with no thrombosis in the proximal veins. No complications occurred intraoperatively. All patients had postoperative ecchymosis, but it was minimal. Three patients had distal thrombotic complications. Superficial phlebitis after complementary surgery occurred in three cases. Complete occlusion with absence of flow 2 to 3 days postoperatively and persisted in the follow-up. No paresthesia occurred in our last series whenever a larger amount of tumescent cold saline was infused around the vein., Conclusion: Endovenous laser ablation of the SSV has excellent early and midterm results. The prevalence of thrombosis and paresthesia is very low. Symptom relief is very good.

Published
2009
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