Balloon Catheter Versus Drill Dilator for EUS-Guided Hepaticogastrostomy Stent Placement: A Randomized Clinical Trial

Abstract

Objectives: A novel partially self-expandable metal stent (PCSEMS) with an anti-migration system has recently become available during Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) but requires tract dilation. No previous study has compared the performance of dilation devices during EUS-HGS. The aim of this randomized controlled trial was to evaluate the technical success rate of tract dilation between a balloon catheter and drill dilator technique during EUS-HGS prior to insertion of SEMS with an anti-migration system.

Methods: A single-center, randomized controlled trial comparing the balloon dilation and drill dilator techniques for first-line tract dilation during EUS-HGS. The primary outcome was the initial technical success rate of tract dilation for each technique during EUS-HGS. The secondary outcome was adverse events associated with the procedures.

Results: Of 54 randomized patients who underwent EUS-HGS at our center, there were 27 in the balloon dilation group and 27 in the drill dilation group. The initial technical success rate was 92.6% (25/27) in the balloon dilation group and 100% (27/27) in the drill dilation group (p = 0.1495). The technical success rate of stent delivery system insertion was significantly higher in the balloon dilation group (88%, 22/25) than in the drill dilation group (45%, 13/27; p = 0.0013). Procedure time was significantly shorter in the balloon dilation group (mean, 9.7 min) than in the drill dilation group (mean, 14.0 min; p = 0.047). Adverse events were more frequent in the drill dilation group (7.4% vs. 29.6%, p = 0.038).

Conclusions: Balloon dilation appears more suitable than drill dilation for PCSEMS with 8.5 Fr stent delivery system deployment.

Clinical trial registration number: University Hospital Medical Information Network 000049550.

Keywords: EUS‐guided hepaticogastrostomy; balloon catheter; balloon dilation; biliary drainage; drill dilator; self‐expandable metal stent; stent placement; tract dilation.