EUS-guided Hepatico-gastrostomy With Hot Giobor

Malignant Biliary Obstruction Clinical Trial

Official title:

A Prospective, Single-center, Single-arm Study to Evaluate the Safety and Effectiveness of a Long Partially Covered Metal Stent With Hot Delivery System (Hot Giobor) for EUS-guided HGS in Patients With Malignant Biliary Obstruction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05804201
• Other study ID #: 2022.460
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Chinese University of Hong Kong
• Contact: Shannon Melissa Chan
• Phone: 35052627
• Email: shannonchan[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Malignant Biliary Obstruction

Intervention

Procedure:
• EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob
(2) The EUS procedure will be performed with a therapeutic echoendoscope with a large working channel under guidance of ultrasound, endoscopy, and fluoroscopy. The echoendoscope will be positioned in the stomach or duodenum. Liver segment III, or sometimes segment II, will be punctured with an 19G needle. After puncture, a guidewire will be introduced in the dilated bile duct, and a Hot Giobor will be placed. All procedures will be performed with the patient and in the supine or prone position under monitored anesthesia.

Locations

Country	Name	City	State
Hong Kong	The Chinese Universtiy of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural / Device related serious adverse events	Any related serious adverse events occured in 1 month post procedure	1 month
Primary	Bilirubin level improvement	Bilirubin level improvement is defined as: > 50% serum bilirubin level is decreased from baseline.	1 month
Secondary	Technical success	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.	During index procedure
Secondary	Clinical success	Bilirubin level improvement is defined as: >20% serum bilirubin level is decreased from baseline.	At day 7
Secondary	Stent patency	Time between stent placement and stent occlusion &/or stent removal.	At 3, 6, 9 and 12 months