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NCT Number: NCT07328308

Delayed Surveillance Colonoscopy Following Piecemeal EMR

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Medical Center

Haifa, Israel

Location contact

Falah, MD

SUB_INVESTIGATOR

Klein

CONTACT

[email protected]

+972-4-7773625

Klein, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2031
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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