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

National Taiwan University

Status: Enrolling

Conditions: 10-20 mm Pedunculated Colorectal Polyp

Treatments: Device: Cold snare polypectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07114380

202505029RINA

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Cold snare polypectomy

Experimental group

Description:

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.

Treatment:

Device: Cold snare polypectomy