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

Masahiro Itonaga; Takeshi Ogura; Hiroyuki Isayama; Mamoru Takenaka; Susumu Hijioka; Hirotoshi Ishiwatari; Reiko Ashida; Atsushi Okuda; Toshio Fujisawa; Kosuke Minaga; Kotaro Takeshita; Yasunobu Yamashita; Nobu Nishioka; Shigeto Ishii; Shunsuke Omoto; Takao Ohtsuka; Keitaro Sofue; Ichiro Yasuda; Toshio Shimokawa; Masayuki Kitano

doi:10.1016/j.gie.2024.11.005

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

Gastrointest Endosc. 2024 Nov 7:S0016-5107(24)03686-1. doi: 10.1016/j.gie.2024.11.005. Online ahead of print.

Authors

Masahiro Itonaga¹, Takeshi Ogura², Hiroyuki Isayama³, Mamoru Takenaka⁴, Susumu Hijioka⁵, Hirotoshi Ishiwatari⁶, Reiko Ashida¹, Atsushi Okuda⁷, Toshio Fujisawa³, Kosuke Minaga⁴, Kotaro Takeshita⁵, Yasunobu Yamashita¹, Nobu Nishioka², Shigeto Ishii³, Shunsuke Omoto⁴, Takao Ohtsuka⁸, Keitaro Sofue⁹, Ichiro Yasuda¹⁰, Toshio Shimokawa¹¹, Masayuki Kitano¹²

Affiliations

¹ Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
² Endoscopy Center, Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Japan.
³ Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
⁴ Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.
⁵ Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
⁶ Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan.
⁷ Second Department of Internal Medicine, Osaka Medical and Pharmaceutical College, Takatsuki, Japan.
⁸ Department of Digestive Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, Japan.
⁹ Department of Radiology, Kobe University Graduate School of Medicine, Japan.
¹⁰ Third Department of Internal Medicine University of Toyama, Toyama, Japan.
¹¹ Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.
¹² Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan. Electronic address: kitano@wakayama-med.ac.jp.

PMID: 39521097
DOI: 10.1016/j.gie.2024.11.005

Abstract

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, 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 the secondary endpoints were the rates of technical success, AEs, recurrent biliary obstruction (RBO), procedure success without using a tract dilation device, re-intervention for RBO, time to RBO (TRBO) and overall survival (OS).

Results: A total of 38 patients underwent EUS-HGS using the Hook stent. Its 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 (10.5%) patients developed early AEs, but there were no severe AEs such as stent migration. RBO developed in 26.3% of patients. Re-intervention for RBO had a 100% success rate. The median TRBO was not reached, and the median OS was 191 days.

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

Keywords: EUS-BD; EUS-HGS; Malignant biliary obstruction; Stent.