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The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps. More precisely, the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips.
Large superficial colonic polyps are increasingly detected thanks to colorectal cancer screening programs worldwide. ESD is the technique which provides a high-quality resection of these large polyps.
Nevertheless, several adverse events affect ESD, especially in the colon. They could be life-threatening, call for or prolong the hospitalization, require blood transfusion, additional endoscopic or surgical procedures and increase costs.
Thus, preventing these adverse events is an important clinical and medico-economic objective. Endoscopic closure of post-ESD defects could reduce this risk. However, closing these large defects with conventional clips can be difficult, unsuccessful and prolong the duration of the whole procedure. A new trough-the-scope suturing system could successfully provide a complete endoscopic closure of post-ESD defects in the colon in a reasonable time.
Expected benefits are a decrease of morbidity and costs related to colonic ESD procedure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESD with clips | No Intervention | Closure of the defect will be performed at the end of the Endoscopic Submucosal Dissection procedure with clips (Boston scientific®). Pictures or movies of the closing defect will be necessary to independently confirm the complete closure. | |
| TTS suturing system | Experimental | Closure of the defect will be performed at the end of the ESD procedure with a new TTS suturing system (X-Tack Boston scientific®). Pictures or movies of the closing defect will be necessary to independently confirm the complete closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTS suturing system | Device | The use of TTS suturing system could allow a quick, complete endoscopic closure of colonic post-ESD defects, providing relevant clinical and medico-economic benefits. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the proportion of complete closure between the two groups | To assess the proportion of complete closure, defined when opposite margins are drawn together without a persistent post-resection defect of more than 1 cm (pictures and/or videos) | Intra-procedural |
| Measure | Description | Time Frame |
|---|---|---|
| duration of the closure procedure | To assess the closure procedure time, which is defined by duration between the beginning of assemblage of the suturing system and the end of the closure in the intervention group and between the opening of the bag of the first clip until the end of the closure in the control group.(pictures-videos) | up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of post-polypectomy syndrome | To assess, it will compare the proportion between the 2 groups of post-polypectomy syndrome at Day 7 | 1 week |
| Proportion of clinically significant delayed bleeding |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Repici, Prof. | Contact | 028224 7493 | alessandro.repici@hunimed.eu | |
| Alessandro D'Aprano, Dr. | Contact | 028224 3678 | alessandro.daprano@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Repici, Prof. | IRCCS Humanitas Research Hospital - Rozzano 20089, Milan, Italy | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36604116 | Background | Morgan E, Arnold M, Gini A, Lorenzoni V, Cabasag CJ, Laversanne M, Vignat J, Ferlay J, Murphy N, Bray F. Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLOBOCAN. Gut. 2023 Feb;72(2):338-344. doi: 10.1136/gutjnl-2022-327736. Epub 2022 Sep 8. | |
| 26818619 | Background |
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The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps. More precisely, the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips.
Considering an α risk set at 5%, a power set at 80%, given an expected complete resection rate of 70% in the control group and of 95% in the experimental group, 33 patients in each group are required. Thus, the investigators will enroll 66 subjects
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Compare and assess the proportion of clinically significant delayed bleeding at 1 month
| 1 month |
| Cost-effectiveness ratio | To assess the cost-effectiveness ratio, estimated by dividing the difference in costs observed between the two strategies by the difference of effectiveness at 1 month. The effectiveness criterion being the closure time at 1 month | 1 month |
| Length of hospitalization | To compare the length of hospitalization defined as the number of procedural nights in the hospitals | up to 1 week |
| Arnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27. |
| 29313949 | Background | Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4. |
| 22612596 | Background | Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, Bresalier R, Andriole GL, Buys SS, Crawford ED, Fouad MN, Isaacs C, Johnson CC, Reding DJ, O'Brien B, Carrick DM, Wright P, Riley TL, Purdue MP, Izmirlian G, Kramer BS, Miller AB, Gohagan JK, Prorok PC, Berg CD; PLCO Project Team. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. N Engl J Med. 2012 Jun 21;366(25):2345-57. doi: 10.1056/NEJMoa1114635. Epub 2012 May 21. |
| 24047059 | Background | Nishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969. |
| 38079634 | Background | Jacques J, Schaefer M, Wallenhorst T, Rosch T, Lepilliez V, Chaussade S, Rivory J, Legros R, Chevaux JB, Leblanc S, Rostain F, Barret M, Albouys J, Belle A, Labrunie A, Preux PM, Lepetit H, Dahan M, Ponchon T, Crepin S, Marais L, Magne J, Pioche M. Endoscopic En Bloc Versus Piecemeal Resection of Large Nonpedunculated Colonic Adenomas : A Randomized Comparative Trial. Ann Intern Med. 2024 Jan;177(1):29-38. doi: 10.7326/M23-1812. Epub 2023 Dec 12. |
| 26966519 | Background | Arezzo A, Passera R, Marchese N, Galloro G, Manta R, Cirocchi R. Systematic review and meta-analysis of endoscopic submucosal dissection vs endoscopic mucosal resection for colorectal lesions. United European Gastroenterol J. 2016 Feb;4(1):18-29. doi: 10.1177/2050640615585470. Epub 2015 May 5. |
| 32542857 | Background | Liu M, Zhang Y, Wang Y, Zhu H, Xu H. Effect of prophylactic closure on adverse events after colorectal endoscopic submucosal dissection: A meta-analysis. J Gastroenterol Hepatol. 2020 Nov;35(11):1869-1877. doi: 10.1111/jgh.15148. Epub 2020 Jul 5. |
| 38011072 | Background | Dong L, Zhu W, Zhang X, Xie X. Does Prophylactic Closure Improve Outcomes After Colorectal Endoscopic Submucosal Dissection? A Systematic Review and Meta-analysis. Surg Laparosc Endosc Percutan Tech. 2024 Feb 1;34(1):94-100. doi: 10.1097/SLE.0000000000001248. |
| 30885778 | Background | Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Wallace MB, Mackenzie TA, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15. |
| 35778927 | Background | Kobara H, Tada N, Fujihara S, Nishiyama N, Masaki T. Clinical and technical outcomes of endoscopic closure of postendoscopic submucosal dissection defects: Literature review over one decade. Dig Endosc. 2023 Jan;35(2):216-231. doi: 10.1111/den.14397. Epub 2022 Aug 25. |
| 36323330 | Background | Farha J, Ramberan H, Aihara H, Zhang LY, Mehta A, Hage C, Schlachterman A, Kumar A, Shinn B, Canakis A, Kim RE, D'Souza LS, Buscaglia JM, Storm AC, Samarasena J, Chang K, Friedland S, Draganov PV, Qumseya BJ, Jawaid S, Othman MO, Hasan MK, Yang D, Khashab MA, Ngamruengphong S; ESD-Closure working group. A novel through-the-scope helix tack-and-suture device for mucosal defect closure following colorectal endoscopic submucosal dissection: a multicenter study. Endoscopy. 2023 Jun;55(6):571-577. doi: 10.1055/a-1970-5528. Epub 2022 Nov 2. |