Prospective feasibility study on the efficacy and safety of a novel spiral dilator for endoscopic ultrasound-guided drainage.

ABSTRACT

Objectives: A difficult step in endoscopic ultrasound (EUS)-guided drainage procedures is dilation of the puncture tract before stent deployment. The efficacy and safety of a novel spiral dilator, Tornus ES, for EUS-guided drainage were investigated in this study. Methods: This study was conducted as a prospective, single-arm, observational study at Sendai City Medical center. Dilation of the puncture tract using a spiral dilator was attempted for all EUS-guided drainage cases. The primary outcome was the technical success rate which was defined as successful stent placement in the puncture tract. Secondary outcomes were the success rate of dilation using a spiral dilator, procedure time, and adverse events related to the procedures. Results: A total of 10 patients were enrolled between January and March 2022. Seven patients underwent EUS-guided biliary drainage (hepaticogastrostomy for six and hepaticojejunostomy for one), and the remaining three patients underwent EUS-guided gallbladder drainage. The technical success rate and the success rate of dilation using a spiral dilator were both 100%. The mean procedure time was 27 min. No adverse events related to the procedure occurred in all cases. Conclusions: Dilation of the puncture tract using a spiral dilator was effective and safe and might make it easier to perform EUS-guided drainage.