N/A
N=164
WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
Biliary Stricture
Bottom Line
View on ClinicalTrials.gov: NCT01543256 ↗Enrolled (actual)
164
Serious AEs
21.3%
Results posted
Jan 2023
Primary outcome: Primary: Number of Participants With Stricture Resolution — 47; 54 Participants — p=.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- WallFlex™ Biliary RX Fully Covered Stent System RMV (Device); Commercially available Plastic Stent Per Investigator preference (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Stricture Resolution |
47; 54 | .008 sig |
| SECONDARY Serious Adverse Events Related to the Device or Procedure |
19; 16 | .568 |
| SECONDARY Number of ERCP Procedures Through 24 Months After Initial Stent Placement. |
2.6; 3.9 | <.001 sig |
| SECONDARY Ability to Deploy Stent(s) in Satisfactory Position (Technical Success) |
79; 82 | .99 |
| SECONDARY Length of Stent Placement and Removal Procedures |
26; 28 | .519 |
| SECONDARY Number of Stents Placed |
2.3; 6.7 | <.001 sig |
Summary
The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of endoscopic retrograde cholangiopancreatography (ERCP) procedures during 24 months.
Statistical testing will be performed to determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group.
Eligibility 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 naïve stricture or at the time of prior plastic stent placement in strictures that had one prior plastic stent inserted.12
- Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts
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 10 Fr 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
Data sourced from ClinicalTrials.gov (NCT01543256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.