Primary percutaneous stenting for palliative biliary drainage of patients with malignant hilar biliary obstruction: TESLA trial.

Background & Aims: Palliative patients with malignant hilar biliary obstruction typically undergo endoscopic or internal/external percutaneous biliary drainage. Both approaches may cause bacterial colonization of the bile ducts, requiring multiple reinterventions. The 90-day mortality rate after palliative drainage is reported to be up to 36%. Few patients become eligible for systemic treatment. Primary percutaneous stenting may avoid infectious complications. The aim of this study was to investigate primary percutaneous stenting in palliative patients with malignant hilar biliary obstruction. Methods: We performed a single-arm phase II trial. Primary percutaneous stenting was performed with uncovered self-expandable metal stents across the hilar tumor without crossing the ampulla. The puncture tract was sealed without leaving an external drain. Outcomes included drainage-related severe complications and the proportion of patients receiving systemic treatment after drainage. Results: From October 2020 until June 2023, 67 patients were included, with perihilar cholangiocarcinoma in 27 patients (40.3%), intrahepatic cholangiocarcinoma in 23 patients (34.3%), gallbladder cancer in nine patients (13.4%), and other tumors in eight patients (12.0%). Drainage-related severe complications within 90 days were observed in 12 patients (17.9%); two patients (3.0%) developed acute cholecystitis, one patient (1.5%) had a biliary leak, three patients (4.5%) had hemorrhage, and six patients (9.0%) had persistent jaundice. No drainage-related 90-day mortality was observed. Cholangitis or pancreatitis was never observed after the first drainage. Palliative systemic treatment was started in 42 patients (62.7%). Conclusions: Primary percutaneous stenting for patients with malignant hilar biliary obstruction had a low incidence of drainage-related complications without any cholangitis or pancreatitis after the first drainage. Palliative systemic treatment was never withheld because of drainage-related complications or inadequate drainage. These results compare favorably to both endoscopic and internal/external percutaneous drainage. Impact and implications: This study demonstrates that primary percutaneous stenting in patients with malignant hilar biliary obstruction results in a low rate of drainage-related complications and enables initiation of systemic therapy in the majority of patients. These findings are clinically relevant for gastroenterologists, interventional radiologists, and oncologists aiming to optimize palliative care while minimizing infectious risks. The approach may offer a safe and effective alternative to conventional drainage strategies, although confirmation in comparative trials is needed to support broader implementation.