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CompletedNCT01543256Updated Jan 9, 2023Results posted

WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

An interventional study of WallFlex™ Biliary RX Fully Covered Stent System RMV and Commercially available Plastic Stent Per Investigator preference in Biliary Stricture, sponsored by Boston Scientific Corporation. Completed at 14 sites in 11 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-09.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
172
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Biliary Stricture

Keywords

  • benign biliary strictures secondary to chronic pancreatitis
03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 172 is above the median of 80 across 448 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
172 participants (actual)

Study arms

  • Active comparator
    Metal stents

    The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.

    Device: WallFlex™ Biliary RX Fully Covered Stent System RMV

  • Active comparator
    Plastic Stents

    Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.

    Device: Commercially available Plastic Stent Per Investigator preference

Interventions

  • DeviceWallFlex™ 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")

  • DeviceCommercially 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: After 12-month stenting period through 24 month follow-up (approximately 12 months)

Secondary outcomes

  1. 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.

    Time frame: Initial stent placement procedure to 24 month follow-up

  2. 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.

    Time frame: Initial stent placement procedure to 24 month follow-up

  3. 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.

    Time frame: Initial stent placement procedure

  4. Length of Stent Placement and Removal Procedures

    Length of stent placement procedures and stent removal procedures.

    Time frame: Initial stent placement procedure to 24 month follow-up

  5. Number of Stents Placed

    Number of stents placed throughout study to 24 month follow-up

    Time frame: Initial stent placement procedure to 24 month follow-up

07

Results

Posted Jan 9, 2023

Participant flow

Participant flow — Overall Study
MilestoneMetal StentsPlastic Stents
Started8084
Completed6270
Not completed1814

Outcome measures

PrimaryNumber 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.

Time frame:
After 12-month stenting period through 24 month follow-up (approximately 12 months)
Reported as:
Count of participants · Participants
Number of Participants With Stricture Resolution
ParticipantsMetal StentsPlastic Stents
Number of Participants With Stricture Resolution4754
Statistical analysis
  • Metal Stents vs Plastic Stents · Exact non-inferiority · p = .008
SecondarySerious 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.

Time frame:
Initial stent placement procedure to 24 month follow-up
Reported as:
Count of participants · Participants
Serious Adverse Events Related to the Device or Procedure
ParticipantsMetal StentsPlastic Stents
Serious Adverse Events Related to the Device or Procedure1916
Statistical analysis
  • Metal Stents vs Plastic Stents · Fisher Exact · p = .568
SecondaryNumber 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.

Time frame:
Initial stent placement procedure to 24 month follow-up
Reported as:
Mean · procedures
Number of ERCP Procedures Through 24 Months After Initial Stent Placement.
proceduresMetal StentsPlastic Stents
Number of ERCP Procedures Through 24 Months After Initial Stent Placement.2.6 ± 1.33.9 ± 1.3
Statistical analysis
  • Metal Stents vs Plastic Stents · Negative binomial · p = <.001
SecondaryAbility 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.

Time frame:
Initial stent placement procedure
Reported as:
Count of participants · Participants
Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)
ParticipantsMetal StentsPlastic Stents
Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)7982
Statistical analysis
  • Metal Stents vs Plastic Stents · Fisher Exact · p = .99
SecondaryLength of Stent Placement and Removal Procedures

Length of stent placement procedures and stent removal procedures.

Time frame:
Initial stent placement procedure to 24 month follow-up
Reported as:
Median · minutes
Length of Stent Placement and Removal Procedures
minutesMetal StentsPlastic Stents
Length of Stent Placement and Removal Procedures26 (3 to 182)28 (5 to 144)
Statistical analysis
  • Metal Stents vs Plastic Stents · Wilcoxon (Mann-Whitney) · p = .519
SecondaryNumber of Stents Placed

Number of stents placed throughout study to 24 month follow-up

Time frame:
Initial stent placement procedure to 24 month follow-up
Reported as:
Mean · number of stents
Number of Stents Placed
number of stentsMetal StentsPlastic Stents
Number of Stents Placed2.3 ± 3.36.7 ± 4.4
Statistical analysis
  • Metal Stents vs Plastic Stents · Negative binomial · p = <.001

Adverse events

Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Metal Stents5/80 (6.3%)19/80 (23.8%)3/80 (3.8%)
Plastic Stents3/84 (3.6%)16/84 (19%)8/84 (9.5%)
Most frequent serious events
Most frequent serious events
EventMetal StentsPlastic Stents
Cholangitis/fever/jaundiceGastrointestinal disorders7/809/84
Abdominal painGastrointestinal disorders5/805/84
CholecystitisGastrointestinal disorders3/691/72
Post-ERCP pancreatitisGastrointestinal disorders2/800/84
Acute-on-chronic pancreatitisGastrointestinal disorders2/800/84
Post-sphincterotomy bleedGastrointestinal disorders1/770/76
Perforation of duodenumGastrointestinal disorders0/801/84
Most frequent other events
Most frequent other events
EventMetal StentsPlastic Stents
Abdominal painGastrointestinal disorders3/804/84
Chronic Obstruction Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders1/800/84
Neuropathy PeripheralNervous system disorders1/800/84
Duodenal UlcerGastrointestinal disorders0/801/84
Gastrointestinal OedemaGastrointestinal disorders0/801/84
Acute PancreatitisGastrointestinal disorders0/801/84
Upper Respiratory Tract InfectionGastrointestinal disorders0/801/84

Baseline characteristics

Age, Continuous
Age, Continuous(years)Metal StentsPlastic StentsTotal
Median51 (28 to 74)53 (23 to 74)52 (26 to 74)
Sex: Female, Male
Sex: Female, Male(Participants)Metal StentsPlastic StentsTotal
Female101222
Male7072142
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Metal StentsPlastic StentsTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Metal StentsPlastic StentsTotal
Canada235
Netherlands5611
Austria81119
Sweden325
Belgium131326
Hong Kong235
Italy161632
Australia437
France6612
Germany112
India202040
Time since chronic pancreatitis (CP) diagnosed
Time since chronic pancreatitis (CP) diagnosed(years)Metal StentsPlastic StentsTotal
Median3.1 (.1 to 35.8)1.7 (.1 to 32.4)1.9 (.1 to 35.8)
Gallbladder in situ
Gallbladder in situ(Participants)Metal StentsPlastic StentsTotal
Count of participants6972141
CP etiology alcoholic
CP etiology alcoholic(Participants)Metal StentsPlastic StentsTotal
Count of participants5453107
Calcifying CP
Calcifying CP(Participants)Metal StentsPlastic StentsTotal
Count of participants5962121

6 further baseline measures are reported on the registry.

08

Study locations

14 sites
  • Royal Prince Alfred Medical Center
    Newtown, New South Wales 2042, Australia
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
  • Allgemeines Krankenhaus AKH
    Vienna, A-1090, Austria
  • Erasme Hospital
    Brussels, 1070, Belgium
  • UZ Gasthuisberg
    Leuven, 3000, Belgium
  • CHUM - Hopital Saint-Luc
    Montreal, Quebec H2X 3J4, Canada
  • Hopital Edouard Herriot
    Lyon, 69437, France
  • Evangelisches Krankenhaus Dusseldorf
    Dusseldorf, D-40217, Germany
  • Prince of Wales Hospital
    Shatin, New Territories, Hong Kong
  • Asian Institute of Gastroenterology
    Hyderabad, 500 082, India
  • Azienda Ospedaliera Universitaria Integrata di Verona
    Verona, VR 37134, Italy
  • Policlinico Universitario Agostino Gemelli
    Rome, 00168, Italy
  • Erasmus Medical Center
    Rotterdam, CE 3015, Netherlands
  • Karolinska Universitets Sjukhuset
    Stockholm, S-14186, Sweden
09

References and documents

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 documents

  • Study protocol · Feb 15, 2013
  • Statistical analysis plan · Mar 20, 2013

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01543256
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Mar 2, 2012
Start date
Sep 18, 2012
Primary completion
Sep 21, 2020
Completion
Sep 21, 2020
Results posted
Jan 9, 2023
Last update
Jan 9, 2023

Study contacts

D.Nageshwar Reddy, MD
principal investigator · Asian Institute of Gastroenterology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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