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
| Registry | NCT05804201 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Chinese University of Hong Kong (Other) |
| Conditions | Malignant Biliary Obstruction |
| Interventions | EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob (Procedure) |
| Dates | start 2023-06-15 (estimated), primary completion 2025-12-31 (estimated), completion 2025-12-31 (estimated), first posted 2023-04-07, last updated 2023-06-02 |
| Locations | 1 site in Hong Kong |
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All trials for Malignant Biliary Obstruction All trials of EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| HOT Giobor | Other | Procedure: 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. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| The Chinese Universtiy of Hong Kong | Hong Kong | Hong Kong |