Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction

The goal of this clinical randomized controlled trial is to perform primary percutaneous stenting (PPS) in patients with malignant hilar biliary obstruction (MHBO). The main question it aims to answer is: To compare the efficacy of PPS above the ampulla to standard endoscopic biliary drainage (EBD) in patients with a MHBO who are ineligible for surgical resection. Researchers will compare PPS with EBD to see if major complications within 90 days after randomisation occur. Participants will undergo either primary percutaneous stenting or endoscopic biliary drainage, depending on randomization.

NCT Number	NCT06671418
Lead Sponsor	Erasmus Medical Center Collaborators: Dutch Cancer Society
Conditions	Cholangiocarcinoma Non-resectable, Gall Bladder Cancer, Liver Metastasis, Malignant Hilar Stricture
Enrollment	148 participants
Start Date	2023-08-09
Primary Completion	2027-11-01 (estimated)
Study Completion	2027-11-01 (estimated)
Updated on ClinicalTrials.gov	2024-11-04