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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Malignant Biliary Obstruction

Treatments: Device: EUS-guided hepaticogastrostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05169398

CRE-2021.447

Details and patient eligibility

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. >= 18 years of age
2. Anatomically feasible for EUS-guided hepatico-gastrostomy
3. Patients with clinical symptoms and/or signs of extrahepatic biliary obstruction (jaundice, biliary-type pain, cholangitis)
4. Patients with unsuccessful ERCP (failed ERCP, anticipated difficult ERCP or high risk for pancreatitis)
5. Written informed consent (and assent when applicable) obtained from subject.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

EUS-guided hepaticogastrostomy

Experimental group

Description:

EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea).

Treatment:

Device: EUS-guided hepaticogastrostomy