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

Abstract Background 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). Patients and Methods 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. Results 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% (40/138) in the PBD group and 26.5% (36/136) in the early surgery group (between-group difference, 2.5%; one-sided upper 95% confidence limit, 11.7%; P = 0.011 for noninferiority). Among 144 PBD patients, 140 (97.2%) received a SEMS; 119 (82.6%) underwent surgery with curative intent. Among 140 early surgery patients, 14 (10.0%) underwent ERCP and drainage; 130 (92.9%) underwent surgery with curative intent in 115 (88.5%). During follow-up, 7.9% (11/138) in the PBD group and 8.0% (11/136) in the early surgery group died. Conclusion Safety following PBD using SEMS was noninferior to early surgery for pancreatic or periampullary cancer. ClinicalTrials.gov, no. NCT01774019.