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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01014390




Registration number
NCT01014390
Ethics application status
Date submitted
13/11/2009
Date registered
17/11/2009
Date last updated
14/06/2016

Titles & IDs
Public title
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
Scientific title
A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures
Secondary ID [1] 0 0
CDM 00027550
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biliary Stricture 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - WallFlex Biliary RX Fully Covered Stent System

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


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Time from stent removal to 1 month post-stent removal
Secondary outcome [1] 0 0
Stricture resolution during stent indwell, defined by lack of stent-related re-interventions
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Stricture resolution after stent removal, defined by lack of stricture-related re-intervention
Timepoint [2] 0 0
Up to 60 months after stent removal
Secondary outcome [3] 0 0
Occurrence and severity of adverse events related to the stent and/or the procedure
Timepoint [3] 0 0
Entire study
Secondary outcome [4] 0 0
Ability to deploy the stent in satisfactory position across the stricture (technical success at placement)
Timepoint [4] 0 0
Stent placement procedure
Secondary outcome [5] 0 0
Length of stent placement procedure, length of stent removal procedure and methods of removal (to include video recording if available)
Timepoint [5] 0 0
Stent placement through removal
Secondary outcome [6] 0 0
Biliary obstructive symptom assessment at all visits: Right Upper Quadrant Pain, Fever/Chills, Jaundice, Itching, Dark urine, Pale stools, Nausea/Vomiting
Timepoint [6] 0 0
Entire Study
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Up to 24 months post-stent removal

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Chile
State/province [5] 0 0
Santiago
Country [6] 0 0
France
State/province [6] 0 0
Lyon
Country [7] 0 0
Germany
State/province [7] 0 0
Dusseldorf
Country [8] 0 0
India
State/province [8] 0 0
Hyderabad
Country [9] 0 0
Italy
State/province [9] 0 0
Rome
Country [10] 0 0
Netherlands
State/province [10] 0 0
Rotterdam
Country [11] 0 0
Spain
State/province [11] 0 0
Catalunya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01014390
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01014390