Preoperative Biliary Drainage with Metal Stent Versus Early Surgery in Patients with Pancreatic Cancer: A Randomized Clinical Trial.

Among patients with pancreatic cancer and biliary obstruction planned for pancreaticoduodenectomy, preoperative biliary drainage (PBD) may be considered during surgical delays. Higher complication rates have been reported for PBD using plastic stents versus early surgery. PBD with a self-expanding metal stent (SEMS) has not been compared with early surgery in a randomized controlled trial (RCT). We conducted a noninferiority RCT comparing PBD using a SEMS versus early surgery at 11 centers in 9 countries. We enrolled patients with resectable pancreatic or periampullary cancer and serum total bilirubin level ≥ 5.8 mg/dL, scheduled for primary resection. Primary endpoint was the proportion of patients reporting ≥ 1 serious adverse event (SAE) 120 days post-randomization. Secondary endpoints included rate of SEMS insertion, rate of curative-intent resection, and all-cause mortality. Among 284 patients, 144 were randomized to PBD and 140 to early surgery. In the modified intention-to-treat primary endpoint analysis, ≥ 1 SAE(s) occurred in 29.0