Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects

Official title

Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects: A Randomized Trial vs Conventional Clips That it Highlights the Importance of Suturing in Promoting Healing and Closure of the Colonic ESD Defects

Overview

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.

Detailed description

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

Interventions

• Device TTS suturing system
  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.

Primary outcome measures

• Compare the proportion of complete closure between the two groups [Time frame: Intra-procedural]

Secondary outcome measures (1)

• duration of the closure procedure [Time frame: up to 2 hours]

Eligibility criteria

Inclusion criteria

• Patient suffering from 30-60 mm colonic polyps with indication of ESD
• Male or female patients aged > 18 years' old
• Patients able to fill in questionnaires written in Italian

Exclusion criteria

• Failure of endoscopic resection
• Suspicion of deep submucosal cancer by analysis of pit pattern (KUDO Vn)
• Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification)
• Polyp inside the ileo-cecal valvula.
• Rectal lesions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 36604116
• 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. PMID 26818619
• 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. PMID 29313949
• 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 PMID 22612596
• 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. PMID 24047059
• 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( PMID 38079634
• 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. PMID 26966519
• 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. PMID 32542857

Identifiers

NCT: NCT06443047 · 3938 - STITCH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗