Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05169398

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

Led by Chinese University of Hong Kong · Updated on 2026-03-20

20

Participants Needed

1

Research Sites

254 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Anatomically suitable for EUS-guided hepaticogastrostomy
  • Presence of clinical symptoms or signs of extrahepatic biliary obstruction such as jaundice, biliary-type pain, or cholangitis
  • History of unsuccessful ERCP, anticipated difficult ERCP, or high risk for pancreatitis
  • Provided written informed consent (and assent if applicable)
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or unwilling to use birth control during the study
  • Coagulopathy with INR greater than 1.5 or platelet count less than 50,000

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Surgery, Prince of Wales Hospital

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

A

Anthony Teoh, FRCSEd

CONTACT

Z

Zero Chung

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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