Phase I/II Prospective Study on Endoscopic Ultrasound-Guided Hepaticogastrostomy as Primary Drainage for Unresectable Malignant Hilar Biliary Obstruction.

OBJECTIVES

Various drainage methods have been used for unresectable malignant hilar biliary obstruction (MHBO). However, controlling cholangitis and obstructive jaundice is still challenging. We performed a phase I/II study of endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) as primary drainage for MHBO.

METHODS

This prospective Phase I/II study included 20 patients requiring biliary drainage for MHBO recruited from June 2021 to December 2023. The primary endpoint was safety. The secondary endpoints were clinical efficacy, reintervention methods, and frequency.

RESULTS

The types of bile duct stenosis were Bismuth type I/II/IIIa/IIIb/IV; 4/1/5/3/7 cases. Fifteen cases (75%) had cholangitis before the EUS-HGS was performed. Technical success rate; 100% (20/20), clinical success rate; 75% (15/20). The four cases in which clinical success was not achieved were Bismuth type IV with cholangitis and obstructive jaundice, and all cases required additional drainage for the right bile duct.Early adverse events were stent migration: one case (severe) and peritonitis: one case (mild).

CONCLUSIONS

The safety of EUS-HGS for the primary drainage of unresectable MHBO is acceptable. Regarding clinical efficacy, based on the results observed in patients with Bismuth type IV obstruction, we acknowledge that further investigation is warranted. Trial Registration: UMIN-CTR: UMIN000047702.