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临床试验/NCT07328308
NCT07328308尚未招募不适用

Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 760 人开始时间: 2026年1月1日最近更新:
干预措施

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

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

Active Comparator

Participants undergo colonoscopy at 6, 18, and 48 months after piecemeal EMR.

干预措施: Colonoscopy after bowel cleansing (Procedure)

Relaxed Surveillance Group

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amir Klein MD

Principal Investigator

Rambam Health Care Campus

研究点 (1)

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