Investigation of Cold Snare Polypectomy for Removing 10-20 mm 0-Ip Colorectal Polyp: One Feasibility and Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Cold snare polypectomy successful resection rate
研究概览
简要总结
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:
- Can cold snare polypectomy achieve complete removal of 10-20 mm pedunculated polyps?
- What are the rates and types of complications associated with this technique?
Participants will:
- Undergo colonoscopy as clinically indicated
- Have 10-20 mm pedunculated polyps removed using cold snare polypectomy if eligible
- Be monitored for post-procedure outcomes, including pathology results and any complications
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years
- •Undergoing colonoscopy for any clinical indication
- •Found to have a 10-20 mm pedunculated colorectal polyp suitable for cold snare polypectomy
排除标准
- •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
结局指标
主要结局
Cold snare polypectomy successful resection rate
时间窗: 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.
次要结局
- Number of Polyps with En Bloc Resection(From the start of the colonoscopy to completion of the procedure, typically within 1 hour.)
- 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.)
- 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.)
- Number of Polyps with Complete Histologic Resection(From end of colonoscopy exam to pathology report, usually within 2 weeks.)
- Number of Polyps Requiring Prophylactic Hemoclipping(From the start of the colonoscopy to completion of the procedure, typically within 1 hour.)
- Number of Polyps Requiring Submucosal Injection(From the start of the colonoscopy to completion of the procedure, typically within 1 hour.)
- Number of Polyps Successfully Retrieved(From the start of the colonoscopy to completion of the procedure, typically within 1 hour.)
- 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.)
- 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.)
- Number of Participants with Perforation(From start of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.)
- 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.)
- Polypectomy time(From the start of the colonoscopy to completion of the procedure, typically within 1 hour.)
- Withdrawal Time(From the start of the colonoscopy to completion of the procedure, typically within 1 hour.)
- Number of Polyps with En Bloc Resection(From the start of the colonoscopy to completion of the procedure, typically within 1 hour.)
- Number of Polyps with Complete Histologic Resection(From end of colonoscopy exam to pathology report, usually within 2 weeks.)
- Number of Polyps Requiring Prophylactic Hemoclipping(From the start of the colonoscopy to completion of the procedure, typically within 1 hour.)
- Number of Polyps Requiring Submucosal Injection(From the start of the colonoscopy to completion of the procedure, typically within 1 hour.)
- Number of Polyps Successfully Retrieved(From the start of the colonoscopy to completion of the procedure, typically within 1 hour.)