Randomized Controlled Trial Investigating Cold Snare aNd Forcep polypectomY Among Small POLYPs in Rates of Complete Resection: the TINYPOLYP Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Completeness of resection
研究概览
简要总结
The focus of the study is to evaluate impact of cold forcep and cold snare in achieving complete resection during polypectomy of polyps <=3mm during colonoscopy.
详细描述
The details of the proposed study are as follows:
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Experimental group: using cold forceps for polyps <=3mm of the colon
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Control group: using cold snare for polyps <=3mm of the colon
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Methods:
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Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
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If polyps <=3mm are identified, the endoscopist is randomized to performing polypectomy with cold forcep or cold snare.
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After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
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The polyp as well as well as the two biopsies are reviewed by a pathologist.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years or older
- •Polyps <=3mm
排除标准
- •Inflammatory bowel disease
- •Polyposis syndromes
研究组 & 干预措施
Cold forcep
Cold forcep polypectomy performed for polyps <=3mm.
干预措施: Cold forcep polypectomy (Procedure)
Cold snare
Cold forcep polypectomy performed for polyps <=3mm.
干预措施: Cold snare polypectomy (Procedure)
结局指标
主要结局
Completeness of resection
时间窗: 2 weeks
The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups.
次要结局
- Time to resection(During the procedure)
- Complications(4 weeks)
- Number of forcep bites or snare attempts(During the procedure)
研究者
Shai Friedland
Professor in Gastroenterology & Hepatology
Stanford University