Delayed Surveillance Colonoscopy Following Piecemeal EMR

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRambam Health Care Campus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years and older

Undergoing pEMR of LNPCPs

Able to provide informed consent and comply with follow-up requirements

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Colonoscopy after bowel cleansing

    Procedure/Surgery

    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.

Treatment groups

760 Participants
are divided into 2 treatment groups
Group A: Standard Surveillance GroupActive comparator 1 intervention
Group B: Relaxed Surveillance GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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