10-20 mm Pedunculated Colorectal Polyp
Conditions
Keywords
cold snare polypectomy, pedunculated polyp, efficacy, safety
Brief 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.
Interventions
DEVICECold 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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cold snare polypectomy successful resection rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Delayed Bleeding After Cold Snare Polypectomy | 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 |
| Number of Participants with Perforation | 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 |
| Number of Participants with Post-Polypectomy Emergency Department Visits | 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 |
| Polypectomy time | 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 |
| Withdrawal Time | 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 |
| Number of Polyps with Immediate Bleeding After Cold Snare Polypectomy | 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, 1. Grade 1: Spontaneous hemostasis within 1 minute 2. Grade 2: Continuous but decreased oozing over 1 minute 3. Grade 3: Continuous oozing over 1 minute 4. Grade 4: Active spurting Unit of Measure: Number of polyps with immediate bleeding, stratified by grade |
| Number of Polyps with Complete Histologic Resection | 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 |
| Number of Polyps Requiring Prophylactic Hemoclipping | 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 |
| Number of Polyps Requiring Submucosal Injection | 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 |
| Number of Polyps Successfully Retrieved | 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 |
| Number of Polyps with En Bloc Resection | 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 |
Countries
Taiwan
Contacts
Primary ContactHsin-Yun Wu, MD
Backup ContactLi-Chun Chang, MD, PhD
Outcome results
None listed