Phase 3
Completed N=187
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
Biliary Stricture
Source: ClinicalTrials.gov NCT01014390 ↗
Enrolled (actual)
187
Serious AEs
27.3%
Results posted
Feb 2020
Primary outcomePrimary: Stent Removability — 132 Participants
◆ Published Evidence
Highly cited
251citations · ~21 / year
Successful management of benign biliary strictures with fully covered self-expanding metal stents.
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.
Linked Publications (4)
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Successful management of benign biliary strictures with fully covered self-expanding metal stents.
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Long-term outcomes after temporary placement of a self-expanding fully covered metal stent for benign biliary strictures secondary to chronic pancreatitis.
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Fully covered self-expanding metal stents for benign biliary stricture after orthotopic liver transplant: 5-year outcomes.
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Treatment of post-cholecystectomy biliary strictures with fully-covered self-expanding metal stents - results after 5 years of follow-up.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stent Removability |
132 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01014390) and the linked publication. 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. Informational only — not medical advice.