RecruitingNot ApplicableNCT05169398

EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent

Sponsor

Chinese University of Hong Kong

Enrollment

20 participants

Start Date

Jan 15, 2022

Study Type

INTERVENTIONAL

Conditions

Malignant Biliary Obstruction

Summary

EUS-guided biliary drainage is gaining popularity as a means of achieving endoscopic drainage in patients with failed endoscopic retrograde cholangiopancreatography (ERCP) 1. EUS-guided hepaticogastrostomy (HGS) is a type of EUS-guided biliary drainage and the procedure is employed when the ERCP fails due to a malignant bile duct obstruction but the papilla is inaccessible or if the first of the duodenum is infiltrated by tumor. Recently, a novel dedicated HGS (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) has become available, the stent has a novel design to that prevents the stent from migration, further improving the safety. The aim of the current study is to evaluate the feasibility and outcomes of the novel lumen apposing stent for EUS-guided HGS. The hypothesis is that the device is safe and effective.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

\>= 18 years of age
Anatomically feasible for EUS-guided hepatico-gastrostomy
Patients with clinical symptoms and/or signs of extrahepatic biliary obstruction (jaundice, biliary-type pain, cholangitis)
Patients with unsuccessful ERCP (failed ERCP, anticipated difficult ERCP or high risk for pancreatitis)
Written informed consent (and assent when applicable) obtained from subject.

Exclusion Criteria2

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
Coagulopathic patients (INR\>1.5, platelets \<50,000)

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