Biliary Stricture
Conditions
Keywords
benign biliary strictures secondary to chronic pancreatitis/post abdominal surgery/post liver transplant
Brief summary
The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.
Interventions
DEVICEWallFlex Biliary RX Fully Covered Stent System
Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 prior other abdominal surgery (to include cholecystectomy) * Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by cholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange of prior plastic stent(s) for management of benign stricture
Exclusion criteria
General: * Placement of the stent in strictures that cannot 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 of benign etiology other than chronic pancreatitis or liver transplant anastomosis or other abdominal surgery * Stricture within 2 cm of duct 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 consent or during the study Additional Specific to Chronic Pancreatitis Patients: * Developing obstructive biliary symptoms associated with an attack of acute pancreatitis Additional Specific to Post-Abdominal Surgery Patients: * History of hepatectomy * History of liver transplant Additional Specific to Liver Transplant Patients: * Live donor transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stent Removability | At stent removal | Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal. |
Countries
Australia, Austria, Belgium, Canada, Chile, France, Germany, India, Italy, Netherlands, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| WallFlex Biliary RX FC Stent System The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.
WallFlex Biliary RX Fully Covered Stent System: Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients. | 187 |
| Total | 187 |
Baseline characteristics
| Characteristic | WallFlex Biliary RX FC Stent System | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 19 Participants | — |
| Age, Categorical Between 18 and 65 years | 168 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 10 participants | — |
| Region of Enrollment Austria | 24 participants | — |
| Region of Enrollment Belgium | 27 participants | — |
| Region of Enrollment Canada | 18 participants | — |
| Region of Enrollment Chile | 3 participants | — |
| Region of Enrollment France | 22 participants | — |
| Region of Enrollment Germany | 10 participants | — |
| Region of Enrollment India | 34 participants | — |
| Region of Enrollment Italy | 15 participants | — |
| Region of Enrollment Netherlands | 17 participants | — |
| Region of Enrollment Spain | 7 participants | — |
| Sex: Female, Male Female | 42 Participants | — |
| Sex: Female, Male Male | 145 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 187 |
| serious Total, serious adverse events | 51 / 187 |
Outcome results
Primary
Stent Removability
Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal.
Time frame: At stent removal
Population: 10 Patients were excluded because of death (from unrelated cause), withdrawal of consent, or switch to palliative treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Biliary RX FC Stent System | Stent Removability | 132 Participants |