NCT Number: NCT07114380
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
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Not applicable
National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From the start of the colonoscopy to completion of the procedure, typically within 1 hour)
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.
Time frame: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.
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
Time frame: From completion of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.
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
Time frame: From start of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.
Definition: Any full-thickness defect of the colonic wall identified during or after the procedure.
Unit of Measure: Number of participants with perforation
Time frame: From start of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.
Definition: Any unplanned emergency department visit related to post-polypectomy complications.
Unit of Measure: Number of participants with emergency department visits
Time frame: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.
Description: Time from when the snaring instrument first appears on the colonoscopy screen to when colonoscope withdrawal resumes after polypectomy.
Unit of Measure: Seconds
Time frame: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.
Description: Total time taken to withdraw the colonoscope from cecum to anus
Unit of Measure: Minutes
Time frame: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.
Description: Whether the polyp was removed in a single piece (en bloc).
Unit of Measure: Number of polyps with en bloc resection
Time frame: From end of colonoscopy exam to pathology report, usually within 2 weeks.
Description: Whether pathology confirms tumor-free margins in the resected specimen.
Unit of Measure: Number of polyps with complete histologic resection
Time frame: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.
Description: Whether hemoclips were applied prophylactically after cold snare polypectomy.
Unit of Measure: Number of polyps requiring prophylactic hemoclipping
Time frame: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.
Description: Whether submucosal injection was required before or during cold snare polypectomy.
Unit of Measure: Number of polyps requiring submucosal injection
Time frame: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.
Description: The number of resected polyps that are successfully retrieved and submitted for histologic evaluation.
Unit of Measure: Number of polyps successfully retrieved
Contact information is provided by the study sponsor or research team.
Hsin-Yun Wu, MD
CONTACT
Li-Chun Chang, MD, PhD
CONTACT
National Taiwan University Hospital
Other
Investigation of Cold Snare Polypectomy for Removing 10-20 mm 0-Ip Colorectal Polyp: One Feasibility and Safety Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
