NCT06671418

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

Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction (TESLA RCT)

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangiocarcinoma Non-resectable
• Gall Bladder Cancer
• Liver Metastasis
• Malignant Hilar Stricture

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2023-08-09
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2024-11-04
• Last updated: 2024-11-04

Locations

1 site across 1 country: Netherlands