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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
(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.
The Chinese Universtiy of Hong Kong
Hong Kong, Hong Kong
Procedural / Device related serious adverse events
Any related serious adverse events occured in 1 month post procedure
Time frame: 1 month
Bilirubin level improvement
Bilirubin level improvement is defined as: \> 50% serum bilirubin level is decreased from baseline.
Time frame: 1 month
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.
Time frame: During index procedure
Clinical success
Bilirubin level improvement is defined as: \>20% serum bilirubin level is decreased from baseline.
Time frame: At day 7
Stent patency
Time between stent placement and stent occlusion \&/or stent removal.
Time frame: At 3, 6, 9 and 12 months
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