Skip to content

Delayed Surveillance Colonoscopy Following Piecemeal EMR

Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07328308
Enrollment
760
Registered
2026-01-09
Start date
2026-01-31
Completion date
2031-01-31
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer Prevention, Polyp Colorectal

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.

Interventions

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.

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Countries

Israel

Contacts

Primary ContactKlein
am_klein@rmc.gov.il+972-4-7773625

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026