Rambam Medical Center
Haifa, Israel
Location contact
Falah, MD
SUB_INVESTIGATOR
Klein
CONTACT
Klein, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07328308
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Haifa, Israel
Falah, MD
SUB_INVESTIGATOR
Klein
CONTACT
Klein, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From patient enrollment until the end of the 48 month follow up period
Contact information is provided by the study sponsor or research team.
Rambam Health Care Campus
Other
Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study
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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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