NCT05804201

EUS-guided Hepatico-gastrostomy With Hot Giobor

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Malignant Biliary Obstruction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-04-07
• Last updated: 2023-06-02

Locations

1 site across 1 country: Hong Kong