Primary percutaneous stenting above the ampulla for palliative biliary drainage of malignant hilar biliary obstruction.

Abstract

527 Background: Most patients with malignant hilar biliary obstruction (MHBO) are ineligible for surgical resection due to distant metastasis, locally advanced disease, or poor performance status. These patients mostly undergo biliary drainage with endoscopic stents or percutaneous drains that cross the ampulla. This approach causes bacterial colonization of the bile ducts, recurrent cholangitis, and biliary reinterventions. Few patients become eligible for palliative systemic chemotherapy, because of inadequate drainage and drainage-related complications. The solution is primary percutaneous stenting (PPS) with one or more fenestrated self-expandable metal stent (SEMS) across the biliary obstruction, without crossing the ampulla. After PPS, the percutaneous transhepatic puncture tract is sealed with glue without leaving an external biliary drain. The aim of this study was to assess the safety, feasibility, and effectiveness of PPS in patients with unresectable MHBO. Methods: A single center prospective study was performed from October 2020 till September 2022 including 35 patients with MHBO who underwent PPS. We made a comparison with a historical cohort of 90 consecutive patients treated with primary endoscopic biliary drainage at our center from 2011 till 2020. Results: All 35 patients had technical successful percutaneous SEMS placement. Perihilar cholangiocarcinoma was present in 15 patients (43%), intrahepatic cholangiocarcinoma in 14 patients (40%), and gallbladder cancer in 6 patients (17%). Two patients required two attempts because the stricture could not be passed at the first attempt. Two patients developed cholecystitis and one patient had melaena due to intrahepatic bleeding of a portal venous branch requiring blood transfusion. One patient (3%) developed cholangitis after the first biliary drainage procedure because the tumor extended up to the ampulla, requiring additional stenting. No cholangitis was seen in the other 34 patients. We made a comparison with a historical cohort of 90 consecutive patients treated with primary endoscopic biliary drainage at our center from 2011 till 2020. Only 3 patients (9%) required a readmission and 3 patients (9%) a reintervention. Palliative systemic chemotherapy was administered in 26 patients (75%) versus 18 patients (20%) after primary endoscopic biliary drainage. The median overall survival was 10.6 months (95% CI 8.1 – not reached) versus 4.3 months (95% CI 3.1 – 6.4) after primary endoscopic biliary drainage. After PPS, no patients died because of cholangitis or drainage-related complications. Conclusions: Primary percutaneous stenting with fenestrated SEMS without crossing the ampulla is safe, feasible, and effective for palliative treatment of patients with MHBO. These promising results need to be confirmed in a randomized controlled trial. Clinical trial information: NL9624 .