Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection.
Not Applicable
Completed
- Conditions
- ClipNon-pedunculated LesionsHaemorrhageEndoscopic Resection
- Registration Number
- NCT02765022
- Lead Sponsor
- Fundacion Miguel Servet
- Brief Summary
An simple-blind, randomized study, to evaluate the efficacy and safety of complete closure with clips of mucosal defects after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 235
Inclusion Criteria
- 18 years and older
- Clinical indication of endoscopic mucosal resection for large-sized (≥ 2cm) non-pedunculated colorectal lesions.
- Medium-high risk of delayed bleeding (DB risk score ≥ 4)
- Informed consent.
Exclusion Criteria
- Patients with colorectal non-pedunculated lesions without endoscopic mucosal resection indication.
- Lesions resected by endoscopic submucosal resection.
- Incomplete resections.
- Resections with suspected deep submucosal invasion.
- Mucosal defects treated with clips for known or suspected damage to the muscle layer.
- Lesions with low risk of delayed bleeding (DB risk score ≤3).
- Patients with any other medical, geographic or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Delayed hemorrhage 15 days post-EMR
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie clip closure in preventing delayed haemorrhage after EMR for non-pedunculated colorectal lesions?
How does clip closure compare to standard-of-care haemostatic agents in preventing post-EMR delayed bleeding in large colorectal lesions?
Are there specific biomarkers that predict successful mucosal defect closure with clips following endoscopic resection of non-pedunculated colorectal lesions?
What are the potential adverse events associated with clip-based mucosal defect closure after EMR and how are they managed?
What alternative devices or combination therapies are being explored for mucosal defect closure in colorectal EMR procedures compared to clip usage?
Trial Locations
- Locations (1)
Eduardo Albeniz Arbizu
🇪🇸Pamplona, Navarra, Spain
Eduardo Albeniz Arbizu🇪🇸Pamplona, Navarra, Spain