Clinical trial · Interventional
Delayed Surveillance Colonoscopy Following Piecemeal EMR
Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer Prevention | — | UNRESOLVED | — |
| Polyp Colorectal | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy after bowel cleansing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Surveillance Group
- description
- Participants undergo colonoscopy at 6, 18, and 48 months after piecemeal EMR.
- interventionNames
- Procedure: Colonoscopy after bowel cleansing
- type
- EXPERIMENTAL
- label
- Relaxed Surveillance Group
- description
- Participants undergo colonoscopy at 12 and 48 months after piecemeal EMR.
- interventionNames
- Procedure: Colonoscopy after bowel cleansing
Primary outcomes (1)
- measure
- Rate of residual/recurrent adenoma (RRA) at first and second surveillance colonoscopy.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available