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

NCT06443047 | Not Yet Recruiting FDA Device

• 1 other identifier: 3938 - STITCH
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Precancerous Lesion of Colon

Keywords

precancerous colorectal lesions

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• duration of the closure procedure

  up to 2 hours

Other Outcomes (4)

• Proportion of post-polypectomy syndrome

  1 week

• Proportion of clinically significant delayed bleeding

  1 month

• Cost-effectiveness ratio

  1 month

Study Arms (2)

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.

Device: TTS suturing system

Interventions

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.

TTS suturing system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Related Publications (12)

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  PMID: 36604116 BACKGROUND

• 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 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.

  PMID: 29313949 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.

  PMID: 22612596 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.

  PMID: 24047059 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.

  PMID: 38079634 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.

  PMID: 26966519 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.

  PMID: 32542857 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.

  PMID: 38011072 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.

  PMID: 30885778 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.

  PMID: 35778927 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.

  PMID: 36323330 BACKGROUND

Study Officials

• Alessandro Repici, Prof.

  IRCCS Humanitas Research Hospital - Rozzano 20089, Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Repici, Prof.

CONTACT

028224 7493; alessandro.repici@hunimed.eu

Alessandro D'Aprano, Dr.

CONTACT

028224 3678; alessandro.daprano@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 5, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04