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

NCT ID: NCT07114380

Last Updated: 2025-09-19

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2028-04-30

Brief Summary

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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:

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

Detailed Description

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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.

Conditions

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10-20 mm Pedunculated Colorectal Polyp

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Cold snare polypectomy

Intervention Type 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.

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

National Taiwan University Hospital, Jinshan Branch

New Taipei City, , Taiwan

Site Status RECRUITING

National Taiwan University Cancer Center

Taipei, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital, Bei-Hu Branch

Taipei, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsin-Yun Wu, MD

Role: CONTACT

+886978232595

Li-Chun Chang, MD, PhD

Role: CONTACT

+886972651258

Facility Contacts

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Hsuan-Ho Lin

Role: primary

+886972654359

Hsin-Yun Wu

Role: primary

+886972655958

Hao-Che Chang

Role: primary

+886972653109

Sheng-Jie Chang

Role: primary

+886972653951

Li-Chun Chang

Role: primary

+886972651258

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.

Reference Type BACKGROUND
PMID: 38775310 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38670139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32122632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38032585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30176072 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36802753 (View on PubMed)

Other Identifiers

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202505029RINA

Identifier Type: -

Identifier Source: org_study_id

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