Delayed Surveillance Colonoscopy Following Piecemeal EMR

NCT ID: NCT07328308

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

760 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2031-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer Prevention Polyp Colorectal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard Surveillance Group

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

Group Type ACTIVE_COMPARATOR

Colonoscopy after bowel cleansing

Intervention Type 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

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

Group Type EXPERIMENTAL

Colonoscopy after bowel cleansing

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Amir Klein MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Klein

Role: CONTACT

+972-4-7773625

Facility Contacts

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Klein

Role: primary

+972-4-7773625

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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RMB-0069-25

Identifier Type: -

Identifier Source: org_study_id

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