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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Malignant Biliary Obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EUS-guided hepaticogastrostomy

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

Group Type EXPERIMENTAL

EUS-guided hepaticogastrostomy

Intervention Type DEVICE

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

Interventions

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EUS-guided hepaticogastrostomy

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No