Malignant Biliary Obstruction
Conditions
Keywords
EUS-guided hepatico-gastrostomy, malignant biliary obstruction
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).
Interventions
PROCEDUREEUS-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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Hong Kong
Contacts
Primary ContactShannon Melissa Chan
Outcome results
None listed