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

Not Applicable

Recruiting

• Conditions: Malignant Biliary Obstruction
• Interventions: Device: EUS-guided hepaticogastrostomy

• Registration Number: NCT05169398
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-12-23
• Study First Posted: 2021-12-27
• Study Start: 2022-01-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Adverse event	30 day	a life-threatening or severe event requiring endoscopic and/or surgical intervention, transfusion or IV/IM antibiotics

Secondary Outcome Measures

Name	Time	Method
Number of patients with technical success	1 day	transmural placement of the stent across the stomach or duodenum into the bile duct
Stent patency	1 year	the period between stent insertion and stent occlusion or stent removal
Number of patients with Clinical success	7 days	decrease of \>20% bilirubin from baseline level

Trial Locations

Locations (1)

Department of Surgery, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong