Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- The primary objective of the study is to compare CBF and CSP in terms of efficacy. The primary end-point is the rate of histological complete resection by anatomopathological examination.
研究概览
简要总结
European guidelines recommend the use of cold snare polypectomy (CSP) for removal of diminutive colorectal polyps (DCP)(5 mm or less). However, for DCP < 4 mm cold biopsy forceps (CBF) may be optional. Moreover, CBF remains the endoscopist's technique of choice for polyp resection and CSP is associated with a failure of specimen retrieval for histology in up to 6.8% of cases. In this study, the investigators aimed to compare the efficacy of CSP with CBF for removal of DCP in routine colonoscopy
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Routine colonoscopy
- •Patient older than 18 years
- •at least one polyp measuring ≤ 5 mm
排除标准
- •inflammatory bowel disease
- •polyposis syndrome, pregnancy
- •inability to provide informed consent
结局指标
主要结局
The primary objective of the study is to compare CBF and CSP in terms of efficacy. The primary end-point is the rate of histological complete resection by anatomopathological examination.
时间窗: through study completion, an average of 2 years.
Complete histological resection was defined as the absence of visualized residual polyp after saline irrigation as well as negative biopsies of the polypectomy site
次要结局
- Procedure time ( overall time between introduction and removal of colonoscope)(through study completion, an average of 2 years.)
- Specimen retrieval rate (% time of polypectomy)(through study completion, an average of 2 years.)
- Procedure related adverse events will be collected (adverse events : %, number of event for each groupe) during the procedure or during the follow up period (28 days).(All patients will be followed-up until 28 days post-colonoscopy.)
研究者
Gabriel RAHMI
Principal Investagator, Medical Doctor
French Society of Digestive Endoscopy