Coelen RJS, et al. - In patients with potentially resectable perihilar cholangiocarcinoma, researchers examined the incidence of severe drainage-related complications of endoscopic biliary drainage or percutaneous transhepatic biliary drainage via performing a multicenter, randomized controlled trial at four academic centers in the Netherlands. Because of higher all-cause mortality in the percutaneous transhepatic biliary drainage group, the investigation was prematurely stopped. They found that post-drainage complications were similar between groups. Because of the small sample size, the data should be interpreted carefully.

Methods

• Study participants who were at least 18 years old with potentially resectable perihilar cholangiocarcinoma requiring major liver resection and biliary obstruction of the future liver remnant (characterized as a bilirubin concentration of >50 μmol/L [2·9 mg/dL]), were randomly assigned (1:1) to receive endoscopic biliary drainage or percutaneous transhepatic biliary drainage through the use of computer-generated allocation.
• Randomization (done by the trial coordinator) was stratified for previous (attempted) biliary drainage, the extent of bile duct involvement, and enrolling center.
• Subjects were selected by clinicians of the participating centers.
• The number of severe complications between randomization and surgery in the intention-to-treat population was the primary outcome.

Results

• Two hundred sixty-one subjects were screened for participation, and 54 eligible patients were randomly assigned to endoscopic biliary drainage (n=27) or percutaneous transhepatic biliary drainage (n=27) from September 26, 2013 to April 29, 2016.
• The investigation was prematurely closed in view of higher mortality in the percutaneous transhepatic biliary drainage group (11 [41%] of 27 patients) than in the endoscopic biliary drainage group (three [11%] of 27 patients; relative risk 3·67, 95% CI 1·15–11·69; p=0·03).
• It was noted that 3 of the 11 deaths among patients in the percutaneous transhepatic biliary drainage group occurred before surgery.
• It was observed that the proportion of patients with severe preoperative drainage-related complications was similar between the groups (17 [63%] patients in the percutaneous transhepatic biliary drainage group vs 18 [67%] in the endoscopic biliary drainage group; relative risk 0·94, 95% CI 0·64–1·40).
• Findings revealed that 16 (59%) patients in the percutaneous transhepatic biliary drainage group and 10 (37%) patients in the endoscopic biliary drainage group developed preoperative cholangitis (p=0·1).
• After endoscopic biliary drainage, 15 (56%) patients required additional percutaneous transhepatic biliary drainage.
• After percutaneous transhepatic biliary drainage, only one (4%) patient required endoscopic biliary drainage.