A Randomized Trial Comparing the Effectiveness of Polyp Resection Treatments (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Efficacy of Resection (Central Post-Resection Biopsies)
研究概览
简要总结
The study will compare the use of cold snare, hot snare, cold EMR, and hot EMR for polyp resection. Although previous studies have compared two of the potential resection methods, no previous study has evaluated all four of the resection methods.
详细描述
The optimal method for removal of polyps 6-9 and 10-15 mm in size is not established. In this study, we propose to evaluate four different treatments for polyps (sized 6mm-15mm). The four treatments are cold snaring without injection, hot snaring without injection, cold EMR, and hot EMR. This study aims to help to establish the optimal resection technique for 6-9 and 10-15 mm polyps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40 years or older
- •Ability to provide informed consent
排除标准
- •Subjects with a history of Inflammatory Bowel Disease
- •Lesions less than 6mm or greater than 15mm in largest dimension
研究组 & 干预措施
Cold Snare
Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques.
干预措施: Cold Snare (Procedure)
Hot Snare
Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques.
干预措施: Hot Snare (Procedure)
Cold EMR
Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques.
干预措施: Cold EMR (Procedure)
Hot EMR
Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques.
干预措施: Hot EMR (Procedure)
结局指标
主要结局
Efficacy of Resection (Central Post-Resection Biopsies)
时间窗: 1 day
Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the central post-resection biopsies. Positive means that there was residual polyp tissue seen on the central post-resection biopsies. Negative central post-resection biopsies are considered a better outcome.
Efficacy of Resection (Peripheral Post-Resection Biopsies)
时间窗: 1 day
Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the peripheral post-resection biopsies. Positive means that there was residual polyp tissue seen on the peripheral post-resection biopsies. Negative peripheral post-resection biopsies are considered a better outcome.
次要结局
未报告次要终点
研究者
Douglas K. Rex
Professor of Medicine
Indiana University