Delayed Surveillance Colonoscopy Following Piecemeal EMR
Starting soon · Not applicable
Conditions studied: Colon Cancer Prevention, Polyp Colorectal
In brief
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.
Key facts
- Study ID
- NCT07328308
- Run by
- Rambam Health Care Campus
- People needed
- 760
- Starts
- 2026-01-01
- Expected to finish
- 2031-01-01
- Last updated by the study team
- 2026-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged 18 years and older
- Undergoing pEMR of LNPCPs
- Able to provide informed consent and comply with follow-up requirements
You may not qualify if…
- 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
Where it is running
- Rambam Medical Center — Haifa, Israel
Full record on ClinicalTrials.gov
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