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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01543256




Registration number
NCT01543256
Ethics application status
Date submitted
14/02/2012
Date registered
2/03/2012
Date last updated
9/01/2023

Titles & IDs
Public title
WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
Scientific title
A Multi-Center, Prospective, Randomized Study Comparing Removable, Self-Expanding Metal Stents to Plastic Stents for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
Secondary ID [1] 0 0
CDM00047682
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
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - WallFlex™ Biliary RX Fully Covered Stent System RMV
Treatment: Devices - Commercially available Plastic Stent Per Investigator preference

Active Comparator: Metal stents - The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.

Active Comparator: Plastic Stents - Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.


Treatment: Devices: WallFlex™ Biliary RX Fully Covered Stent System RMV
Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell. ("RMV" in intervention name indicates "removable")

Treatment: Devices: Commercially available Plastic Stent Per Investigator preference
Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Stricture Resolution
Timepoint [1] 0 0
After 12-month stenting period through 24 month follow-up (approximately 12 months)
Secondary outcome [1] 0 0
Serious Adverse Events Related to the Device or Procedure
Timepoint [1] 0 0
Initial stent placement procedure to 24 month follow-up
Secondary outcome [2] 0 0
Number of ERCP Procedures Through 24 Months After Initial Stent Placement.
Timepoint [2] 0 0
Initial stent placement procedure to 24 month follow-up
Secondary outcome [3] 0 0
Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)
Timepoint [3] 0 0
Initial stent placement procedure
Secondary outcome [4] 0 0
Length of Stent Placement and Removal Procedures
Timepoint [4] 0 0
Initial stent placement procedure to 24 month follow-up
Secondary outcome [5] 0 0
Number of Stents Placed
Timepoint [5] 0 0
Initial stent placement procedure to 24 month follow-up

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

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/09/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/09/2020
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Medical Center - Newtown
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2042 - Newtown
Recruitment postcode(s) [2] 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
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
France
State/province [5] 0 0
Lyon
Country [6] 0 0
Germany
State/province [6] 0 0
Dusseldorf
Country [7] 0 0
Hong Kong
State/province [7] 0 0
New Territories
Country [8] 0 0
India
State/province [8] 0 0
Hyderabad
Country [9] 0 0
Italy
State/province [9] 0 0
VR
Country [10] 0 0
Italy
State/province [10] 0 0
Rome
Country [11] 0 0
Netherlands
State/province [11] 0 0
CE
Country [12] 0 0
Sweden
State/province [12] 0 0
Stockholm

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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01543256
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
D.Nageshwar Reddy, MD
Address 0 0
Asian Institute of Gastroenterology
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