NCT07114380

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

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

• 10-20 mm Pedunculated Colorectal Polyp

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-08-25
• Primary completion: 2028-03-01
• Completion: 2028-04-01
• First posted: 2025-08-11
• Last updated: 2025-09-19

Locations

5 sites across 1 country: Taiwan

Regulatory

• FDA-regulated device study