Status:
COMPLETED
Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR)
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
UMC Utrecht
Maastricht University Medical Center
Conditions:
Polyp, Colonic
Bleeding
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study design: A national, multi-center, patient-blinded, randomized clinical trial. Study population: Patients undergoing EMR with a moderate to severe risk (right sided colon, ≥2cm) of developing De...
Detailed Description
Design This is a multi-center, randomized, patient-blinded multicenter trial, comparing two treatment strategies in 356 patients undergoing EMR for a colonic lesion 2-6 cm. The study will be enrolled...
Eligibility Criteria
Inclusion
- laterally spreading or sessile polyp morphology (Paris classification 0-IIa/b/c) proximal to the splenic flexure, measuring 2-6 cm
- All patients aged \>18 years undergoing an EMR
- Written informed consent
Exclusion
- Previous resection or attempted resection of a lesion less than 30 days ago or in the same session,
- Clip deployed prior to the completion of the EMR for a perforation or a major intra-procedural bleeding not treatable by coagulation,
- Endoscopic appearance of invasive malignancy (non-lifting Kato D, Kudo V pit pattern),
- Pregnancy,
- Active inflammatory colonic conditions (e.g. inflammatory bowel disease),
- Insufficiently corrected anticoagulants AND/OR a clotting disorder (platelet count \<50x109/l, INR \> 1,5),
- American Society of Anesthesiology (ASA) Grade IV-V,
- Macroscopic non-radical resection,
- \>1 lesion in 1 session,
- Involvement of valvula Bauhin or appendiceal orificium
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT03309683
Start Date
March 5 2018
End Date
March 1 2023
Last Update
March 30 2023
Active Locations (2)
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1
Ziekenhuis St Jansdal
Harderwijk, Gelderland, Netherlands, 3844DG
2
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525GA