Investigation of Cold Snare Polypectomy for Removing 10-20 mm 0-Ip Colorectal Polyp

Официальное название

Investigation of Cold Snare Polypectomy for Removing 10-20 mm 0-Ip Colorectal Polyp: One Feasibility and Safety Study

Обзор

This is a multicenter, single-arm feasibility study conducted across multiple hospitals in Taiwan. The goal of this trial is to evaluate whether cold snare polypectomy is a feasible and safe method for removing 10-20 mm pedunculated colorectal polyps. The main questions it aims to answer are: 1. Can cold snare polypectomy achieve complete removal of 10-20 mm pedunculated polyps? 2. What are the rates and types of complications associated with this technique? Participants will: 1. Undergo colonoscopy as clinically indicated 2. Have 10-20 mm pedunculated polyps removed using cold snare polypectomy if eligible 3. Be monitored for post-procedure outcomes, including pathology results and any complications

Подробное описание

This is a prospective, multicenter, single-arm clinical trial designed to evaluate the feasibility and safety of cold snare polypectomy (CSP) for the removal of 10-20 mm pedunculated (0-Ip) colorectal polyps. While CSP is widely recommended for polyps \<10 mm due to its favorable safety profile and comparable efficacy to hot snare polypectomy (HSP), its application for larger pedunculated polyps remains insufficiently studied, particularly given concerns regarding bleeding risk.

The study will enroll 120 adult participants undergoing colonoscopy at one of five hospitals in Taiwan. Participants found to have 10-20 mm 0-Ip polyps that are deemed amenable to CSP will undergo cold snare resection by experienced endoscopists. Standard pre- and post-procedure care will be followed. Polyp characteristics, resection outcomes, and complications (e.g., immediate or delayed bleeding, perforation, emergency visits) will be recorded.

Primary endpoints include technical success (complete removal as assessed by endoscopy and pathology) and safety (rate of adverse events such as bleeding or perforation). Clinical and procedural data will be collected prospectively, and statistical analysis will be conducted to identify predictors of CSP failure using univariate and multivariate models.

This study aims to fill a critical knowledge gap in the literature regarding the appropriateness of CSP for larger pedunculated lesions and inform future guideline recommendations.

Вмешательства

• Устройство Cold snare polypectomy
  Unlike traditional hot snare polypectomy or endoscopic mucosal resection, which use electrocautery to resect larger or pedunculated polyps, cold snare polypectomy uses mechanical transection alone without cautery. The procedure is performed using a dedicated cold snare by experienced endoscopists.

Первичные конечные точки

• Cold snare polypectomy successful resection rate [Срок оценки: From the start of the colonoscopy to completion of the procedure, typically within 1 hour)]

Вторичные конечные точки (11)

• Number of Polyps with Immediate Bleeding After Cold Snare Polypectomy [Срок оценки: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.]
• Number of Participants with Delayed Bleeding After Cold Snare Polypectomy [Срок оценки: From completion of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.]
• Number of Participants with Perforation [Срок оценки: From start of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.]
• Number of Participants with Post-Polypectomy Emergency Department Visits [Срок оценки: From start of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.]
• Polypectomy time [Срок оценки: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.]
• Withdrawal Time [Срок оценки: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.]
• Number of Polyps with En Bloc Resection [Срок оценки: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.]
• Number of Polyps with Complete Histologic Resection [Срок оценки: From end of colonoscopy exam to pathology report, usually within 2 weeks.]
• Number of Polyps Requiring Prophylactic Hemoclipping [Срок оценки: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.]
• Number of Polyps Requiring Submucosal Injection [Срок оценки: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.]
• Number of Polyps Successfully Retrieved [Срок оценки: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.]

Критерии участия

Критерии включения

• Age ≥ 20 years
• Undergoing colonoscopy for any clinical indication
• Found to have a 10-20 mm pedunculated colorectal polyp suitable for cold snare polypectomy

Критерии исключения

• Age < 20 years
• Medical contraindications to colonoscopy or polypectomy (e.g., recent myocardial infarction, stroke, severe unstable cardiovascular disease, acute peritonitis, fulminant colitis, perforation, or toxic megacolon)
• Inadequate bowel preparation preventing complete colonoscopy or safe polypectomy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 5 центров

• National Taiwan University Hospital Hsin-Chu Branch — Hsinchu
• National Taiwan University Hospital, Jinshan Branch — New Taipei City
• National Taiwan University Cancer Center — Taipei
• National Taiwan University Hospital, Bei-Hu Branch — Taipei
• National Taiwan University Hospital — Taipei

Публикации

• Tseng CH, Chang LC, Wu JL, Chang CY, Chen CY, Chen PJ, Shun CT, Hsu WF, Chen YN, Chen CC, Huang TY, Tu CH, Chen MJ, Chou CK, Lee CT, Chen PY, Lin JT, Wu MS, Chiu HM. Bleeding Risk of Cold Versus Hot Snare Polypectomy for Pedunculated Colorectal Polyps Measuring 10 mm or Less: Subgroup Analysis of a Large Randomized Controlled Trial. Am J Gastroenterol. 2024 Nov 1;119(11):2233-2240. doi: 10.14309/a PMID 38775310
• Ferlitsch M, Hassan C, Bisschops R, Bhandari P, Dinis-Ribeiro M, Risio M, Paspatis GA, Moss A, Libanio D, Lorenzo-Zuniga V, Voiosu AM, Rutter MD, Pellise M, Moons LMG, Probst A, Awadie H, Amato A, Takeuchi Y, Repici A, Rahmi G, Koecklin HU, Albeniz E, Rockenbauer LM, Waldmann E, Messmann H, Triantafyllou K, Jover R, Gralnek IM, Dekker E, Bourke MJ. Colorectal polypectomy and endoscopic mucosal res PMID 38670139
• Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1095-1129. doi: 10.1053/j.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available. PMID 32122632
• Copland AP, Kahi CJ, Ko CW, Ginsberg GG. AGA Clinical Practice Update on Appropriate and Tailored Polypectomy: Expert Review. Clin Gastroenterol Hepatol. 2024 Mar;22(3):470-479.e5. doi: 10.1016/j.cgh.2023.10.012. Epub 2023 Nov 28. PMID 38032585
• Qu J, Jian H, Li L, Zhang Y, Feng B, Li Z, Zuo X. Effectiveness and safety of cold versus hot snare polypectomy: A meta-analysis. J Gastroenterol Hepatol. 2019 Jan;34(1):49-58. doi: 10.1111/jgh.14464. Epub 2018 Sep 26. PMID 30176072
• Chang LC, Chang CY, Chen CY, Tseng CH, Chen PJ, Shun CT, Hsu WF, Chen YN, Chen CC, Huang TY, Tu CH, Chen MJ, Chou CK, Lee CT, Chen PY, Wu MS, Chiu HM. Cold Versus Hot Snare Polypectomy for Small Colorectal Polyps : A Pragmatic Randomized Controlled Trial. Ann Intern Med. 2023 Mar;176(3):311-319. doi: 10.7326/M22-2189. Epub 2023 Feb 21. PMID 36802753

Идентификаторы

NCT: NCT07114380 · 202505029RINA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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