Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 760
- 试验地点
- 1
- 主要终点
- Rate of residual/recurrent adenoma (RRA) at first and second surveillance colonoscopy.
研究概览
简要总结
This multicenter, prospective, randomized non inferiority trial, conducted at four Israeli hospitals, will evaluate whether a relaxed surveillance strategy after piecemeal endoscopic mucosal resection (pEMR) of large non pedunculated colorectal polyps (LNPCPs, ≥20 mm) is as safe and effective as the current standard intensive surveillance. Approximately 760 adults undergoing complete pEMR with margin ablation will be randomized 1:1 into:
Standard Surveillance: Colonoscopy at 6, 18, and 48 months
Relaxed Surveillance: Colonoscopy at 12 and 48 months
All colonoscopies will be performed using high definition white light and narrow band imaging, with biopsies obtained only if recurrence is suspected. The investigators hypothesize that a relaxed surveillance strategy will be non inferior to the current standard intensive surveillance. If non inferiority is demonstrated, the study may support guideline changes toward reduced surveillance frequency after pEMR with margin ablation, potentially decreasing patient burden and healthcare costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 aged 18 years and older
- •Undergoing pEMR of LNPCPs
- •Able to provide informed consent and comply with follow-up requirements
排除标准
- •Patients with invasive cancer identified during the index procedure
- •en bloc resection
- •Patients unable to attend follow-up colonoscopies due to comorbid conditions
- •Patients who require additional surgery for polyp removal or other complications
研究组 & 干预措施
Standard Surveillance Group
Participants undergo colonoscopy at 6, 18, and 48 months after piecemeal EMR.
干预措施: Colonoscopy after bowel cleansing (Procedure)
Relaxed Surveillance Group
Participants undergo colonoscopy at 12 and 48 months after piecemeal EMR.
干预措施: Colonoscopy after bowel cleansing (Procedure)
结局指标
主要结局
Rate of residual/recurrent adenoma (RRA) at first and second surveillance colonoscopy.
时间窗: From patient enrollment until the end of the 48 month follow up period
次要结局
未报告次要终点
研究者
Amir Klein MD
Principal Investigator
Rambam Health Care Campus
