Clinical trial NCT05804201: EUS-guided Hepatico-gastrostomy With Hot Giobor
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malignant Biliary Obstruction
Keywords: EUS-guided hepatico-gastrostomy, malignant biliary obstruction
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Procedural / Device related serious adverse events
timeFrame: 1 month
measure: Bilirubin level improvement
timeFrame: 1 month
Secondary outcomes:
measure: Technical success
timeFrame: During index procedure
measure: Clinical success
timeFrame: At day 7
measure: Stent patency
timeFrame: At 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese Universtiy of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Shannon Melissa Chan
role: PRINCIPAL_INVESTIGATOR
References: