Status:
NOT_YET_RECRUITING
PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Malignant Biliary Obstruction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Endoscopic retrograde cholangiopancreatography (ERCP) stands as the primary approach for addressing jaundice in individuals with distal malignant biliary obstruction. A premise element in achieving su...
Detailed Description
Rationale of the study Patients with distal malignant biliary obstruction have a higher risk of ERCP failure, related to the difficulty of bile duct cannulation. These patients after standard ERCP str...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Patients with distal malignant biliary obstruction
- Abdominal ultrasound or computed tomography or magnetic resonance or EUS showing a dilated common bile duct \> 15 mm diameter.
- Difficult biliary cannulation defined as ESGE guidelines
- Agree to receive follow up phone calls
- Able to provide written informed consent
Exclusion
- Coagulation and/or platelets hereditary disorders and/or INR\>1.5, PLT\<50,000 103/mm3.
- Use of anticoagulants that cannot be discontinued
- Pregnant women
- Previous ERCP or EUS-BD attempt
- Inability to sign the informed consent
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06550973
Start Date
October 1 2024
End Date
September 30 2026
Last Update
August 13 2024
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