Metal Stent Drainage vs Early Surgery in Pancreatic Cancer

Key Takeaways

• In this randomized comparison, metal-stent drainage was associated with 120-day serious-adverse-event rates that met the reported noninferiority criterion versus early surgery.
• Participants had resectable pancreatic or periampullary cancer with biliary obstruction, serum total bilirubin of at least 5.8 mg/dL, and planned primary resection.

In a multicenter randomized clinical trial, serious adverse events by 120 days occurred in 29.0% of patients assigned to metal-stent drainage and 26.5% assigned to early surgery. The study compared preoperative biliary drainage with a self-expanding metal stent against early surgery in patients with obstructed, resectable pancreatic or periampullary cancer.

The multicenter noninferiority randomized trial was conducted across 11 centers in 9 countries and was published on 08 April 2026. Enrollment was limited to patients with resectable pancreatic or periampullary cancer, biliary obstruction, and a serum total bilirubin level of at least 5.8 mg/dL. All were scheduled for primary resection and were assigned either to preoperative biliary drainage using a self-expanding metal stent or to early surgery.

In the modified intention-to-treat 120-day serious adverse event analysis, 29.0% of patients in the drainage group had at least one event, compared with 26.5% in the early-surgery group. The one-sided upper 95% confidence limit was 11.7%, and P = 0.011 met the noninferiority test.

Secondary outcomes included SEMS insertion, surgery, and all-cause mortality. Among 144 patients assigned to drainage, 140 received a self-expanding metal stent, a completion rate of 97.2%. Surgery with curative intent was performed in 119 of 144 patients in that group, or 82.6%. In the early-surgery group, 14 of 140 patients underwent ERCP and drainage, and 130 of 140 underwent surgery; 115 of those underwent surgery with curative intent. During follow-up, all-cause mortality was 7.9% (11/138) after drainage and 8.0% (11/136) after early surgery.

The findings reflect a short-term safety comparison between two randomized strategies for obstructed, resectable pancreatic or periampullary cancer. Within the reported 120-day period, metal-stent preoperative drainage met the stated noninferiority criterion versus early surgery.