This trial is active, not recruiting.

Condition biliary stricture
Treatment wallflex biliary rx fully covered stent system
Phase phase 3
Sponsor Boston Scientific Corporation
Start date December 2009
End date November 2012
Trial size 187 participants
Trial identifier NCT01014390, CDM 00027550


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.

Primary Outcomes

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 Outcomes

Stricture resolution during stent indwell, defined by lack of stent-related re-interventions
time frame: Up to 12 months
Stricture resolution after stent removal, defined by lack of stricture-related re-intervention
time frame: Up to 60 months after stent removal
Occurrence and severity of adverse events related to the stent and/or the procedure
time frame: Entire study
Ability to deploy the stent in satisfactory position across the stricture (technical success at placement)
time frame: Stent placement procedure
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
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.