A multicenter randomized controlled trial comparing metallic stent with 10-mm versus 14-mm diameter for distal biliary obstruction caused by unresectable pancreatic carcinoma Outstanding Award

Background & Aims: A 10-mm metal stent (MS) is the standard for biliary drainage in patients with unresectable pancreatic cancer (UPC), but larger MS may offer longer patency. This study aimed to compare outcomes between 14-mm and 10-mm uncovered MS.
Methods: In this multicenter, randomized controlled trial, patients with UPC requiring biliary drainage were assigned to either a 10-mm or 14-mm uncovered MS group. The primary endpoint was time to recurrent biliary obstruction (TRBO), while secondary endpoints included early adverse events (AEs) and overall survival (OS). Additionally, we analyzed risk factors associated with TRBO.
Results: A total of 120 patients were enrolled, with 58 receiving a 10-mm MS and 56 receiving a 14-mm MS. The median TRBO was 10.6 months vs. not reached (p = 0.099), and the median OS was 7.54 vs. 8.67 months (p = 0.95) in the 10-mm and 14-mm groups, respectively. Early AEs occurred in 16.7% vs. 8.5% of patients (p = 0.27). Multivariate analysis identified tumor size as an independent risk factor for TRBO.
Conclusions: While the 14-mm group showed a trend toward longer TRBO, the difference was not statistically significant. No significant difference was observed in the occurrence of AEs.