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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Malignant Biliary Obstruction

Clinical Trial Details

NCT number	NCT05169398
Study type	Interventional
Source	Chinese University of Hong Kong
Contact	Anthony Teoh, FRCSEd
Phone	35052956
Email	anthonyteoh@surgery.cuhk.edu.hk
Status	Recruiting
Phase	N/A
Start date	January 15, 2022
Completion date	November 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04941924` - The ID- RFA Trial: A Trial of Intraductal Radio-frequency Ablation (ID-RFA) Plus Biliary Stenting Versus Biliary Stenting Alone for the Treatment of Malignant Biliary Obstruction.	N/A
Active, not recruiting	`NCT03672019` - A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage
Recruiting	`NCT05220475` - A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent	N/A
Completed	`NCT02001779` - IRS(Irradiation Stent) vs. CS(Conventional Stent) Insertion in Inoperable Malignant Biliary Obstruction	N/A
Not yet recruiting	`NCT06375954` - EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)	N/A
Not yet recruiting	`NCT06375928` - EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)	N/A
Recruiting	`NCT05786326` - Multihole Fully Covered Metallic Stents in the Management of Malignant Biliary Obstruction	N/A
Not yet recruiting	`NCT06375967` - EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)	N/A
Completed	`NCT01869894` - A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction	N/A
Not yet recruiting	`NCT05804201` - EUS-guided Hepatico-gastrostomy With Hot Giobor	N/A
Recruiting	`NCT01686425` - Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage	N/A
Recruiting	`NCT03215108` - Comparison Between Novel Flower-type Covered Stent and Conventional Covered Stent	N/A
Recruiting	`NCT04898777` - EUS-Guided Choledochoduodenostomy Versus ERCP for Primary Biliary Decompression in Distal Malignant Biliary Obstruction	N/A
Enrolling by invitation	`NCT05233293` - Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma	N/A
Completed	`NCT03812250` - EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction	N/A
Completed	`NCT03000855` - EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures	Phase 2/Phase 3
Recruiting	`NCT01073514` - Clinical Trial of Bile Etiology ,Proteomics and Metabonomics of Malignant Biliary Obstruction	N/A
Recruiting	`NCT05142839` - Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction.	N/A
Recruiting	`NCT05729867` - Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC	N/A
Completed	`NCT04405752` - Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study