benign blockage of bile duct due to chronic pancreatitis or benign biliary obstruction due to chronic pancreatitis
Conditions
Interventions
Patients who are consented and meet inclusion/exclusion criteria will undergo
stenting procedure(s) with either the WallFlex Biliary Fully Covered Stent
System or standard of care plastic stents (1:
Sponsors
Boston Scientific Cooperation International
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 • Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice for at least one month or cholestasis associated with at least 3 times normal alkaline phosphatase levels) documented at time of enrollment for naive stricture or at the time of prior plastic stent placement - in strictures that had one prior plastic stent inserted. • Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts
Exclusion criteria
Exclusion criteria: • Biliary stricture of benign etiology other than chronic pancreatitis • Prior biliary metal stent or any plastic stenting other than one plastic stent of 10Fr or less for 6 months or fewer. • Developing obstructive biliary symptoms associated with an attack of acute pancreatitis • Biliary stricture of malignant etiology • Stricture within 2 cm of common bile duct bifurcation • Known bile duct fistula or leak • Subjects for whom endoscopic techniques are contraindicated • Known sensitivity to any components of the stent or delivery system • Symptomatic duodenal stenosis (with gastric stasis) • Participation in another investigational study within 90 days prior to consent • Investigator Discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Stricture resolution at 24 months. Stricture resolution at 24 months is defined by the following two criteria being met: • Absence of re-stenting after the per-protocol stenting period through the 24 month visit • Absence of cholestasis at the 24 month visit, defined as alkaline phosphatase level not exceeding 2 times the level at completion of the per-protocol stenting period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Occurrence of adverse events related to the stent and/or the stent placement or removal procedures 2. Number of ERCP procedures through 24 months after initial stent placement 3. Ability to deploy the stent(s) in satisfactory position 4. Stent removal: - Ability to remove the stent(s) without serious stent removal related adverse events at each procedure involving removal of stent(s) (technical success at removal) - Complete distal migration without serious stent removal related adverse events 5. Liver Function Tests (LFT*s): - Baseline LFTs compared to LFTs taken at the time of original plastic stent placement for any subject with a prior plastic stent. - LFT improvement at month 1 compared to baseline LFTs (and/or compared to LFTs taken at the time of original plastic stent placement for any subject with a prior plastic stent) - LFTs at month 24 compared to LFTs at removal of last stent (applicable for subjects who had not been re-stented at time of month 24 visit) 6. Health Economic Endpoints: o Number of outpatient procedures o Number of hospitalizations o Duration of hospitalizations o Length of procedures o Number of devices | — |
Countries
Netherlands
Outcome results
None listed