Investigation of Cold Snare Polypectomy for Removing 10-20 mm 0-Ip Colorectal Polyp
NCT ID: NCT07114380
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-08-25
2028-04-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cold snare polypectomy
Participants in this single-arm study will undergo cold snare polypectomy (CSP) for removal of 10-20 mm pedunculated colorectal polyps identified during clinically indicated colonoscopy. CSP will be performed using standard cold snares without electrocautery. The procedure will be conducted by experienced endoscopists, and all peri-procedural care will follow routine clinical protocols. Outcomes will include complete resection rate, procedure time, and occurrence of adverse events such as immediate or delayed bleeding, perforation, and emergency visits.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Undergoing colonoscopy for any clinical indication
* Found to have a 10-20 mm pedunculated colorectal polyp suitable for cold snare polypectomy
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Li-Chun Chang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, , Taiwan
National Taiwan University Hospital, Jinshan Branch
New Taipei City, , Taiwan
National Taiwan University Cancer Center
Taipei, , Taiwan
National Taiwan University Hospital, Bei-Hu Branch
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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/ajg.0000000000002847. Epub 2024 May 9.
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 resection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2024. Endoscopy. 2024 Jul;56(7):516-545. doi: 10.1055/a-2304-3219. Epub 2024 Apr 26.
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.
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.
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.
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.
Other Identifiers
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202505029RINA
Identifier Type: -
Identifier Source: org_study_id
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