Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary...

Area of Science:

• Gastroenterology
• Interventional Radiology
• Oncology

Background:

• Malignant hilar biliary obstruction often results from cholangiocarcinoma, leading to jaundice and complications from endoscopic drainage.
• Endoscopic biliary drainage, the current standard, frequently causes cholangitis, reinterventions, and high mortality.
• Primary percutaneous stenting (PPS) is proposed to mitigate these drainage-related complications.

Purpose of the Study:

• To compare the efficacy and safety of primary percutaneous stenting (PPS) versus endoscopic biliary drainage.
• To evaluate complication rates, reinterventions, and survival in patients with unresectable malignant hilar biliary obstruction.

Main Methods:

• A multicenter, phase 3 randomized controlled trial (TESLA RCT) involving 148 patients.
• Patients with unresectable malignant hilar biliary obstruction will be randomized to either PPS with self-expandable metal stents or standard endoscopic biliary drainage.
• The primary endpoint is major complications within 90 days post-randomization.

Main Results:

• The TESLA RCT is currently enrolling patients, with the first patient randomized on August 9, 2023.
• Results regarding the primary endpoint (major complications) and secondary outcomes are pending.

Conclusions:

• The study will provide critical data on the comparative effectiveness of PPS and endoscopic biliary drainage for malignant hilar biliary obstruction.
• Findings will inform clinical practice and potentially establish a new standard of care for this patient population.