benign blockage of the bile duct or benign biliary obstruction
Conditions
Interventions
Patients who are consented and meet inclusion / exclusion criteria will undergo
a stenting procedure with the Wall Flex Fully Covered Biliary RX Stent System.
The stent will remain in patients fro
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age 18 or older • Willing and able to comply with the study procedures and provide written informed consent to participate in the study • Chronic pancreatitis or prior liver transplantation or other prior abdominal surgery (cholecystectomy to include) • Indicated for ERCP with stent placement procedure for: o Symptomatic bile duct stricture (ie obstructive Jaundice, persistent cholestasis, acute cholangitis) confirmed by cholangiogram and / or o Bile duct stricture confirmed by cholangiogram and / or o Exchange of prior plastic stent (s) for management of benign stricture
Exclusion criteria
Exclusion criteria: General • Placement of the stent in strictures that can not be dilated enough to pass the delivery system • Placement of the stent in a perforated duct • Placement of the stent in very small intrahepatic ducts • Patients for whom endoscopic techniques are contraindicated • Biliary stricture of malignant etiology • Biliary stricture or benign etiology other than chronic pancreatitis or liver transplant anastomosis or other abdominal surgery • duct stricture within 2 cm of Bifurcation • Symptomatic duodenal stenosis (with gastric stasis) • Prior Biliary self-expanding metal stent • Suspected stricture ischemia based on imaging of hepatic artery occlusion or endoscopic evidence of Biliary cast syndrome • Known bile duct fistula • Known sensitivity to any components of the stent or delivery system • Participation in another investigational study within 90 days prior to or during the study consent ;Additional Specific to Chronic Pancreatitis Patients • Developing Biliary obstructive symptoms associated with an attack of acute pancreatitis ;Additional Specific to Post-Abdominal Surgery Patients • History of hepatectomy • History of liver transplant (only for post-abdominal surgery group);Additional Specific to Liver Transplant Patients • Live donor transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Stent Removability, defined as ability to remove the stent endoscopically without stent removal related serious adverse events as Assessed from the time of stent removal to 1 month post-stent removal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: 1. Stricture during stent indwelling resolution, defined by lack of stent-related re-interventions 2. Stricture resolution after stent removal, defined by lack of stricture-related re-intervention 3. Occurrence and severity of adverse events related to the stent and / or the procedure 4. Ability to deploy the stent in satisfactory position across the stricture (technical success at placement) 5. Length of stent placement procedure, length of stent removal procedure and methods of removal (to include video recording if available) 6. Biliary obstructive symptom assessment at all visits 7. Liver Function Tests (LFTs) at baseline, at 1 month post-stent placement, at stent removal and at 6 months, 12 and 24 post-stent removal | — |
Countries
Netherlands
Outcome results
None listed