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Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction
Sponsor: Erasmus Medical Center
Summary
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.
Official title: Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction (TESLA RCT)
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
148
Start Date
2023-08-09
Completion Date
2027-11-01
Last Updated
2024-11-04
Healthy Volunteers
No
Conditions
Interventions
Primary percutaneous stenting (PPS)
PPS bridging malignant hilar biliary obstruction with self-expandable uncovered metal stents without crossing the ampulla and without leaving an external drain. The procedure is performed by an interventional radiologist who has performed at least 5 PPS procedures.
Endoscopic biliary drainage
EBD according to the American Society for Gastrointestinal Endoscopy (ASGE) guidelines of 2021. The procedure is performed by a gastro-enterologist who is experienced in performing EBD in patients with a MHBO.
Locations (1)
Erasmus MC
Rotterdam, Netherlands