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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold snare polypectomy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold snare polypectomy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cold snare polypectomy successful resection rate | The investigators will record whether each polyp is removed by cold snare polypectomy with or without resistance. These will be considered successful resection cases. Polyps that cannot be removed by cold snare polypectomy and require switching to hot snare polypectomy will be considered failed resection cases. | From the start of the colonoscopy to completion of the procedure, typically within 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Polyps with Immediate Bleeding After Cold Snare Polypectomy | Definition: Immediate bleeding would be assessed and graded during the procedure. The severity grades were listed as followed,
Unit of Measure: Number of polyps with immediate bleeding, stratified by grade |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsin-Yun Wu, MD | Contact | +886978232595 | kimwu010063@gmail.com | |
| Li-Chun Chang, MD, PhD | Contact | +886972651258 | lichunchang@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Li-Chun Chang, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Hsin-Chu Branch | Recruiting | Hsinchu | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38775310 | Background | 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. | |
| 38670139 |
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|
| 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 | Definition: Any bleeding episode occurring after the patient has left the endoscopy unit and within 14 days post-polypectomy, classified as: Mild: Bleeding stops spontaneously without medical intervention Severe: Hemoglobin drop >2 g/dL from baseline, need for blood transfusion, or requirement of endoscopic, angiographic, or surgical hemostasis Unit of Measure: Number of participants with delayed bleeding | From completion of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure. |
| Number of Participants with Perforation | Definition: Any full-thickness defect of the colonic wall identified during or after the procedure. Unit of Measure: Number of participants with perforation | 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 | Definition: Any unplanned emergency department visit related to post-polypectomy complications. Unit of Measure: Number of participants with emergency department visits | From start of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure. |
| Polypectomy time | Description: Time from when the snaring instrument first appears on the colonoscopy screen to when colonoscope withdrawal resumes after polypectomy. Unit of Measure: Seconds | From the start of the colonoscopy to completion of the procedure, typically within 1 hour. |
| Withdrawal Time | Description: Total time taken to withdraw the colonoscope from cecum to anus Unit of Measure: Minutes | From the start of the colonoscopy to completion of the procedure, typically within 1 hour. |
| Number of Polyps with En Bloc Resection | Description: Whether the polyp was removed in a single piece (en bloc). Unit of Measure: Number of polyps with en bloc resection | From the start of the colonoscopy to completion of the procedure, typically within 1 hour. |
| Number of Polyps with Complete Histologic Resection | Description: Whether pathology confirms tumor-free margins in the resected specimen. Unit of Measure: Number of polyps with complete histologic resection | From end of colonoscopy exam to pathology report, usually within 2 weeks. |
| Number of Polyps Requiring Prophylactic Hemoclipping | Description: Whether hemoclips were applied prophylactically after cold snare polypectomy. Unit of Measure: Number of polyps requiring prophylactic hemoclipping | From the start of the colonoscopy to completion of the procedure, typically within 1 hour. |
| Number of Polyps Requiring Submucosal Injection | Description: Whether submucosal injection was required before or during cold snare polypectomy. Unit of Measure: Number of polyps requiring submucosal injection | From the start of the colonoscopy to completion of the procedure, typically within 1 hour. |
| Number of Polyps Successfully Retrieved | Description: The number of resected polyps that are successfully retrieved and submitted for histologic evaluation. Unit of Measure: Number of polyps successfully retrieved | From the start of the colonoscopy to completion of the procedure, typically within 1 hour. |
| National Taiwan University Hospital, Jinshan Branch | Recruiting | New Taipei City | 20844 | Taiwan |
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| National Taiwan University Cancer Center | Recruiting | Taipei | Taiwan |
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| National Taiwan University Hospital, Bei-Hu Branch | Recruiting | Taipei | Taiwan |
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| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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| Background |
| 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. |
| 32122632 | Background | 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. |
| 38032585 | Background | 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. |
| 30176072 | Background | 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. |
| 36802753 | Background | 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. |