Endocuff-assisted vs. Standard Colonoscopy for Surveillance of Serrated Polyposis Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Number of serrated lesions >=5mm
研究概览
简要总结
Serrated Polyposis Syndrome (SPS) is a high-risk condition for colorectal cancer (CRC). SPS patients have a cumulative CRC risk of 1.9% in 5 years despite a strict endoscopic surveillance in specialized centers. Proximal serrated lesions are endoscopically challenging to detect due to their unremarkable morphology. Endocuff is a novel device comprised of a cap with a row of finger-like projections with a unique dynamic shape that help to flatten mucosal folds during withdrawal of the instrument in order to improve detection of lesions. Recent studies have reported an increase of detection rate and mean per patient of adenomas with Endocuff-assisted Colonoscopy compared with Standard Colonoscopy. The purpose of this study is to assess the usefulness of Endocuff-assisted Colonoscopy to detect serrated lesions in SPS patients undergoing surveillance compared to Standard Colonoscopy in a randomized fashion
详细描述
According to own data and similarly to previous published studies, patients diagnosed of Serrated Polyposis Syndrome undergoing annual surveillance after clearance of all serrated lesions ≥ 5mm, have a mean of 5 serrated lesions per patient at follow-up colonoscopies. The study was powered to establish a 25% significant increase in the mean of serrated lesions per patient in the Endocuff-assisted colonoscopy group. Accepting an alpha risk of 0.05, a beta risk of 0.2 and a loss rate of 10% in a bilateral contrast, a sample size of 124 patients (62 in each arm) are required to achieve statistic significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with diagnosis of Serrated Polyposis Syndrome undergoing surveillance colonoscopies after clearance of all lesions >=5mm
排除标准
- •Patients with known strictures
- •Partial or total colonic resection
- •Acute diverticulitis
- •Concomitant inflammatory bowel disease
- •Suspected or proven lower gastrointestinal bleeding
- •Non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure
- •Inability to sign informed consent
研究组 & 干预措施
Endocuff-assisted Colonoscopy
Endocuff-assisted Colonoscopy with the ARC Endocuff-vision® attached at the distal tip of the scope.
干预措施: Endocuff-assisted Colonoscopy (Device)
Standard Colonoscopy
Standard Colonoscopy without any additional device
结局指标
主要结局
Number of serrated lesions >=5mm
时间窗: one year
Number of serrated lesions \>=5mm detected in each arm
次要结局
- Number of total polyps(one year)
- Number of serrated lesions >=10mm(one year)
- Number of serrated lesions with displasia(one year)
- Number of adenomas(one year)
- Number of advanced adenomas(one year)
- Number of flat lesions(one year)
- Number of flat lesions in right colon(one year)
- Withdrawal time(30 minutes)
- Total procedure time(30 minutes)
- Proportion of major adverse events(Two weeks)
- Proportion of minor adverse events(Two weeks)
研究者
María Pellisé
MD. PhD. Consultant
Hospital Clinic of Barcelona