Delayed Surveillance Colonoscopy Following Piecemeal EMR

NCT07328308 | Not Yet Recruiting

• 1 other identifier: RMB-0069-25
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 1

Brief 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

Colon Cancer Prevention; Polyp Colorectal

Outcome Measures

Primary Outcomes (1)

• Rate of residual/recurrent adenoma (RRA) at first and second surveillance colonoscopy.

  From patient enrollment until the end of the 48 month follow up period

Study Arms (2)

Standard Surveillance Group

ACTIVE COMPARATOR

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

Procedure: Colonoscopy after bowel cleansing

Relaxed Surveillance Group

EXPERIMENTAL

Participants undergo colonoscopy at 12 and 48 months after piecemeal EMR.

Procedure: Colonoscopy after bowel cleansing

Interventions

Colonoscopy after bowel cleansing PROCEDURE

The 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.

Relaxed Surveillance Group; Standard Surveillance Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

Central Study Contacts

Klein

CONTACT

+972-4-7773625; am_klein@rmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2031
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)