NCT05804201

EUS-guided Hepatico-gastrostomy With Hot Giobor

Status unknown NA Last updated 2 June 2023

What this trial tests

NA trial testing EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob in Malignant Biliary Obstruction in 30 participants. Status unknown.

Timeline

15 June 2023

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	15 June 2023
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across Hong Kong

Drugs / interventions tested

• EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob

Conditions studied

• Malignant Biliary Obstruction — all drugs for Malignant Biliary Obstruction →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, any sex, with Malignant Biliary Obstruction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Endoscopic ultrasonography-guided hepaticogastrostomy (EUS-HGS) is a method of obtaining biliary drainage in patients with failed or difficult endoscopic retrograde cholangiopancreatography (ERCP). The reason for failure of ERCP can be due to gastric outlet obstruction or failed cannulation. HGS involves placement of a stent between the bile duct and the stomach under the guidance of endoscopic ultrasound to create a biliary drainage route similar to surgery. The overall reported success rate is 94% with an overall complication rate of 14%. The most common complications include pneumoperitoneum (air leaking into the abdomen) and bile leak. Both complications are usually managed conservatively. EUS-gudied HGS has been commonly performed but the type of stent used for the procedure is still under evolution. A specific stent is needed to prevent complications. The most commonly used stent in HK is a hybrid stent where the liver portion is uncovered to avoid stent migration and the rest of the stent is covered to avoid bile leakage and pneumoperitonum. This stent is already available and is called the Giobor stent. However, in order to use this stent, during the EUS procedure, the bile duct needs to be first punctured by a EUS needle, then a guidewire passed, then dilate the tract with an energy deviced 6Fr cytotome, then the stent can be passed. This process is cumbersome and increase the chance of complications during exchange of the devices. A newly developed stent that is cautery-fitted has been developed. The use of this stent shortens the steps of stent application. The current study aims to evaluate the feasibility and safety of a novel stent that is cautery-fitted designed for performance of EUS-HGS (Niti-S HOT Giobor).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.