Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07328308

Delayed Surveillance Colonoscopy Following Piecemeal EMR

Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
760 (estimated)
Sponsor
Rambam Health Care Campus · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREColonoscopy after bowel cleansingThe procedure is performed by experienced endoscopists using high-definition white light and narrow-band imaging to carefully inspect the colon and assess the resection site. Biopsies are taken only if abnormal tissue or recurrence is suspected.

Timeline

Start date
2026-01-01
Primary completion
2027-01-01
Completion
2031-01-01
First posted
2026-01-09
Last updated
2026-01-09

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT07328308. Inclusion in this directory is not an endorsement.