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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2024
  • participants needed
    20
  • sponsor
    Chinese University of Hong Kong
Updated on 7 January 2022

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.

Description

This is a prospective feasibility study enrolling patients suffering from malignant biliary obstruction with failed or anticipated difficult ERCP. Consecutive patients satisfying the inclusion criteria would be recruited.

EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent. The MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) is a novel device designed for hepaticogastrostomy. The stent is a partially covered metal stent made by nitinol covered with silicone. One end of the stent is uncovered and designed for placement in the intrahepatic ducts. The other end has a self-folding design that creates a flange and prevents migration of the stent outside the stomach. The stent diameter is either 8 or 10mm and the length can be 6,8,10 or 12cm long.

Outcome parameters include safety, technical and clinical success

Details
Condition Malignant Biliary Obstruction
Treatment EUS-guided hepaticogastrostomy
Clinical Study IdentifierNCT05169398
SponsorChinese University of Hong Kong
Last Modified on7 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

>= 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 Criteria

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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