Biliary StrictureNCT01543256
WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
A study testing WallFlex™ Biliary RX Fully Covered Stent System RMV and Commercially available Plastic Stent Per Investigator preference in people with Biliary Stricture, run by Boston Scientific Corporation at 14 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biliary Stricture
- What is being tested?
- WallFlex™ Biliary RX Fully Covered Stent System RMV and Commercially available Plastic Stent Per Investigator preference
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 14 sitesin 11 countries
- Study dates
- 18 Sep 2012to 21 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
14 sites in 11 countries.
14 sites in 11 countries
Australia2 sites
Royal Prince Alfred Medical Center
Newtown, New South Wales, 2042
Westmead Hospital
Westmead, New South Wales, 2145
Italy2 sites
Policlinico Universitario Agostino Gemelli
Rome, 00168
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, VR, 37134
About this study
Official 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
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.
- Conditions
- Biliary Stricture
- Being tested
- WallFlex™ Biliary RX Fully Covered Stent System RMV, Commercially available Plastic Stent Per Investigator preference
- Keywords
- benign biliary strictures secondary to chronic pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WallFlex™ Biliary RX Fully Covered Stent System RMVDevice
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")
Commercially available Plastic Stent Per Investigator preferenceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Metal stents | Active comparator | The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. Receives: Device: WallFlex™ Biliary RX Fully Covered Stent System RMV |
| Plastic Stents | Active comparator | Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. Receives: Device: Commercially available Plastic Stent Per Investigator preference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Stricture Resolution
Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.
Measured: After 12-month stenting period through 24 month follow-up (approximately 12 months)
Secondary outcomes (5)
Serious Adverse Events Related to the Device or Procedure
Device or procedure related serious adverse events from the initial stent placement procedure to the 24 month follow-up.
Measured: Initial stent placement procedure to 24 month follow-up
Number of ERCP Procedures Through 24 Months After Initial Stent Placement.
The number of endoscopic retrograde cholangiopancreatography (ERCP) procedures through 24 months, after initial stent placement.
Measured: Initial stent placement procedure to 24 month follow-up
Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)
Technical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure.
Measured: Initial stent placement procedure
Length of Stent Placement and Removal Procedures
Length of stent placement procedures and stent removal procedures.
Measured: Initial stent placement procedure to 24 month follow-up
Number of Stents Placed
Number of stents placed throughout study to 24 month follow-up
Measured: Initial stent placement procedure to 24 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study start18 Sep 2012
- Primary completion21 Sep 2020
- Study completion21 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- D.Nageshwar Reddy, MD, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543256
- Sponsor's protocol ID
- CDM00047682
- Status last verified
- Dec 2021
- First submitted
- 14 Feb 2012
- Last updated
- 9 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramchandani M, Lakhtakia S, Costamagna G, Tringali A, Puspoek A, Tribl B, Dolak W, Deviere J, Arvanitakis M, van der Merwe S, Laleman W, Ponchon T, Lepilliez V, Gabbrielli A, Bernardoni L, Bruno MJ, Poley JW, Arnelo U, Lau J, Roy A, Bourke M, Kaffes A, Neuhaus H, Peetermans J, Rousseau M, Reddy DN. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.
PubMed 33741314
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01543256
- Acronym / sponsor ID
- CDM00047682
- Conditions
- Biliary Stricture
- Keywords
- benign biliary strictures secondary to chronic pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2012 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Posted 9 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal stents | Active comparator | Device: WallFlex™ Biliary RX Fully Covered Stent System RMVThe WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. |
| Plastic Stents | Active comparator | Device: Commercially available Plastic Stent Per Investigator preferencePlastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WallFlex™ Biliary RX Fully Covered Stent System RMVTemporary 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") | Device | Metal stents |
| Commercially available Plastic Stent Per Investigator preferenceTemporary 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. | Device | Plastic Stents |
Primary outcome
Number of Participants With Stricture Resolution
Time frame: After 12-month stenting period through 24 month follow-up (approximately 12 months)
Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.
5 secondary outcomes
Serious Adverse Events Related to the Device or Procedure
Time frame: Initial stent placement procedure to 24 month follow-up
Number of ERCP Procedures Through 24 Months After Initial Stent Placement.
Time frame: Initial stent placement procedure to 24 month follow-up
Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)
Time frame: Initial stent placement procedure
Length of Stent Placement and Removal Procedures
Time frame: Initial stent placement procedure to 24 month follow-up
Number of Stents Placed
Time frame: Initial stent placement procedure to 24 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33741314Ramchandani M, Lakhtakia S, Costamagna G, Tringali A, Puspoek A, Tribl B, Dolak W, Deviere J, Arvanitakis M, van der Merwe S, Laleman W, Ponchon T, Lepilliez V, Gabbrielli A, Bernardoni L, Bruno MJ, Poley JW, Arnelo U, Lau J, Roy A, Bourke M, Kaffes A, Neuhaus H, Peetermans J, Rousseau M, Reddy DN. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D.Nageshwar Reddy, MD principal investigator
Asian Institute of Gastroenterology, India
14 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WallFlex™ Biliary RX Fully Covered Stent System RMV and Commercially available Plastic Stent Per Investigator preference in people with Biliary Stricture, run by Boston Scientific Corporation at 14 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Australia, Belgium, Italy, Austria, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Stricture Resolution (time frame: After 12-month stenting period through 24 month follow-up (approximately 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01543256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.