Usefulness of a dedicated laser-cut metal stent with an anchoring hook and thin delivery system for EUS-guided hepaticogastrostomy in malignant biliary obstruction: a prospective multicenter trial (with video).

BACKGROUND AND AIMS: EUS-guided hepaticogastrostomy (EUS-HGS) carries a risk of serious adverse events (AEs). A newly designed, partially covered laser-cut stent with antimigration anchoring hooks and a thin tapered tip (7.2F), called a Hook stent (Zeon Medical, Tokyo, Japan), has been developed to prevent serious AEs associated with EUS-HGS. The present prospective multicenter clinical trial evaluated the efficacy and safety of the Hook stent for EUS-HGS after failure of ERCP in patients with unresectable malignant biliary obstruction.

METHODS

The primary endpoint was the rate of clinical success, and secondary endpoints were the rates of technical success, AEs, recurrent biliary obstruction (RBO), procedure success without using a tract dilation device, reintervention for RBO, time to RBO, and overall survival (OS).

RESULTS

Thirty-eight patients underwent EUS-HGS using the Hook stent. The technical and clinical success rates in patients undergoing EUS-HGS were 100% and 92.1%, respectively. The procedure success rate without using a tract dilation device was 94.7%. Four patients (10.5%) developed early AEs, but there were no severe AEs such as stent migration. RBO developed in 26.3% of patients. Reintervention for RBO had a 100% success rate. The median time to RBO was not reached, and the median OS was 191 days.

CONCLUSIONS

EUS-HGS using the Hook stent demonstrated a high clinical success rate, low rate of early AEs, and an acceptable stent patency. The Hook stent is safe and feasible for use in patients undergoing EUS-HGS. (Clinical trial registration number: jRCT2052210020.).