Delayed Surveillance Colonoscopy Following Piecemeal EMR

Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Polyp Colorectal; Colon Cancer Prevention
• Intervention / Treatment: Procedure: Colonoscopy after bowel cleansing

• Study Type: Interventional
• Enrollment (Estimated): 760
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klein; Phone Number: +972-4-7773625; Email: am_klein@rmc.gov.il

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Medical Center
    • Contact: Klein; Phone Number: +972-4-7773625; Email: am_klein@rmc.gov.il
    • Principal Investigator: Klein, MD
    • Sub-Investigator: Falah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years and older
• Undergoing pEMR of LNPCPs
• Able to provide informed consent and comply with follow-up requirements

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Surveillance Group; Participants undergo colonoscopy at 6, 18, and 48 months after piecemeal EMR.	Procedure: Colonoscopy after bowel cleansing; 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.
Experimental: Relaxed Surveillance Group; Participants undergo colonoscopy at 12 and 48 months after piecemeal EMR.	Procedure: Colonoscopy after bowel cleansing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: January 3, 2026
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RMB-0069-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No