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WallFlex Biliary Fully Covered (FC) Benign Stricture Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01014390
Recruitment Status : Unknown
Verified June 2016 by Boston Scientific Corporation.
Recruitment status was:  Active, not recruiting
First Posted : November 17, 2009
Last Update Posted : June 14, 2016
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Biliary Stricture Device: WallFlex Biliary RX Fully Covered Stent System Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures
Study Start Date : December 2009
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: WallFlex Biliary RX FC Stent System
The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.
Device: 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.

Primary Outcome Measures :
  1. 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 1 month post-stent removal. [ Time Frame: Time from stent removal to 1 month post-stent removal ]

Secondary Outcome Measures :
  1. Stricture resolution during stent indwell, defined by lack of stent-related re-interventions [ Time Frame: Up to 12 months ]
  2. Stricture resolution after stent removal, defined by lack of stricture-related re-intervention [ Time Frame: Up to 60 months after stent removal ]
  3. Occurrence and severity of adverse events related to the stent and/or the procedure [ Time Frame: Entire study ]
  4. Ability to deploy the stent in satisfactory position across the stricture (technical success at placement) [ Time Frame: Stent placement procedure ]
  5. Length of stent placement procedure, length of stent removal procedure and methods of removal (to include video recording if available) [ Time Frame: Stent placement through removal ]
  6. Biliary obstructive symptom assessment at all visits: Right Upper Quadrant Pain, Fever/Chills, Jaundice, Itching, Dark urine, Pale stools, Nausea/Vomiting [ Time Frame: Entire Study ]
  7. Liver Function Tests (LFT's) at baseline, at month 1 post-stent placement, at stent removal and at months 6, 12 and 24 post-stent removal [ Time Frame: Up to 24 months post-stent removal ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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:


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01014390

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Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Medical University of Vienna
Vienna, Austria
ULB Erasme Hospital
Brussels, Belgium
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada
Canada, Quebec
Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
Montreal, Quebec, Canada, H2X 3J4
MUHC - McGill University
Montreal, Quebec, Canada
Clinica Alemana de Santiago
Santiago, Chile
Hopital Edouard Herriot
Lyon, France
Evangelischen Krankenhaus
Dusseldorf, Germany
Asian Institute of Gastroenterology
Hyderabad, India
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
Rome, Italy, 00168
Erasmus Medical Center
Rotterdam, Netherlands
Hospital Universitari Doctor Josep Trueta
Girona, Catalunya, Spain
Sponsors and Collaborators
Boston Scientific Corporation

Additional Information:
Publications of Results:
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Responsible Party: Boston Scientific Corporation Identifier: NCT01014390     History of Changes
Other Study ID Numbers: CDM 00027550
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Keywords provided by Boston Scientific Corporation:
benign biliary strictures secondary to chronic pancreatitis/post abdominal surgery/post liver transplant
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases