EUS-guided Hepatico-gastrostomy With Hot Giobor

Not Applicable

Not yet recruiting

• Conditions: Malignant Biliary Obstruction
• Interventions: Procedure: EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob

• Registration Number: NCT05804201
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-07
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-02
• Study Start: 2023-06-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Consecutive patients ≥ 18 years old
• Anatomically feasible for EUS-guided hepatico-gastrotomy
• Patient with clinical symptoms and/or sign of extra-hepatic biliary obstruction (jaundice, biliary-type pain, cholangitis)
• Patients with unsuccessful ERCP (failed ECRP, anticipated difficult ERCP or high risk for pancreatitis)
• Written informed consent (and assent when applicable) obtained from subject

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Exclusion Criteria

• Severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary disease, sepsis, or a bleeding disorder)
• Life expectancy of less than 1 month
• History of gastric surgery
• Coagulation disorders
• Pregnancy, breastfeeding, or unwilling to practice birth control during participation in the study
• Severe allergy to Nickel

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HOT Giobor	EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob	EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giobor (Taewoong Medical, Gyeonggi-do, Korea), a novel device designed for hepatico-gastrostomy.

Primary Outcome Measures

Name	Time	Method
Procedural / Device related serious adverse events	1 month	Any related serious adverse events occured in 1 month post procedure
Bilirubin level improvement	1 month	Bilirubin level improvement is defined as: \> 50% serum bilirubin level is decreased from baseline.

Secondary Outcome Measures

Name	Time	Method
Clinical success	At day 7	Bilirubin level improvement is defined as: \>20% serum bilirubin level is decreased from baseline.
Stent patency	At 3, 6, 9 and 12 months	Time between stent placement and stent occlusion \&/or stent removal.
Technical success	During index procedure	Hot Giobor stent is placed at the desired site: transmural placement of the Hot Giobor stent across the stomach or duodenum into the bile duct.

Trial Locations

Locations (1)

The Chinese Universtiy of Hong Kong; 🇭🇰 Hong Kong, Hong Kong