Related Experiment Video
Updated: Jun 27, 2026
Application of Simplified Stent-bridging Pancreaticogastrostomy in Open Pancreaticoduodenectomy
Published on: March 17, 2026
A multicenter randomized controlled trial comparing 10-mm versus 14-mm metallic stents for distal biliary obstruction
Hirotoshi Ishiwatari1, Kazunari Nakahara2, Shinya Kawaguchi3
1Department of Pancreatobiliary Medicine, Shizuoka Cancer Center, Shizuoka, Japan; Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan.
Background And Aims:
ERCP with metal stent (MS) placement is the standard treatment for biliary drainage in patients with unresectable pancreatic cancer. A 10-mm diameter MS is generally used; however, a larger stent may provide longer patency. This study aimed to compare the outcomes of an uncovered 14-mm MS with those of an uncovered 10-mm MS.
Methods:
This multicenter randomized controlled trial enrolled patients with unresectable pancreatic cancer who required biliary drainage. After 1:1 randomization, either an uncovered 10-mm or 14-mm MS was placed through the major duodenal papilla, and the outcomes were compared. The primary end point was time to recurrent biliary obstruction (TRBO), and the secondary end points were adverse events (AEs) and overall survival (OS).
Results:
A total of 118 patients were enrolled from 20 institutions (60 in the 10-mm group and 58 in the 14-mm group). Recurrent biliary obstruction occurred in 41.7% versus 25.8% of patients (P = .08). The median TRBO was 10.6 months versus not reached (P = .10), and the median OS was 7.5 months versus 8.7 months (P = .95) in the 10- and 14-mm groups, respectively. Early AEs occurred in 6.7% and 8.6% of patients (P = .74). No significant difference in late AEs was observed between the groups (21.7% vs 17.2%, P = .64).
Conclusions:
The 14-mm group demonstrated a longer TRBO; however, the difference did not reach statistical significance. No significant differences in AEs were observed between the groups.
Clinical Trial Registration:
The University Hospital Medical Information Network Center (registration no. UMIN000035387).
