Delayed Surveillance Colonoscopy Following Piecemeal EMR
NCT ID: NCT07328308
Last Updated: 2026-01-09
Study Results
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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NOT_YET_RECRUITING
NA
760 participants
INTERVENTIONAL
2026-01-31
2031-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Standard Surveillance Group
Participants undergo colonoscopy at 6, 18, and 48 months after piecemeal EMR.
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.
Relaxed Surveillance Group
Participants undergo colonoscopy at 12 and 48 months after piecemeal EMR.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Undergoing pEMR of LNPCPs
* Able to provide informed consent and comply with follow-up requirements
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Amir Klein MD
Principal Investigator
Locations
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Rambam Medical Center
Haifa, , Israel
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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RMB-0069-25
Identifier Type: -
Identifier Source: org_study_id
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