WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01543256
First received: February 14, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 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.


Condition Intervention Phase
Biliary Stricture
Device: WallFlex™ Biliary RX Fully Covered Stent System RMV
Device: Commercially available Plastic Stent Per Investigator preference
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Stricture resolution [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group. The null hypothesis is that the stricture resolution rate is non-inferior in the Metal Stent Arm versus the Plastic Stent Arm.


Secondary Outcome Measures:
  • Occurrence of adverse events related to the stent and/or the stent placement or removal procedures. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Number of ERCP procedures through 24 months after initial stent placement. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Ability to deploy the stent(s) in satisfactory position(technical success at placement). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Ability to remove the stent(s) without serious stent removal related adverse events at each procedure involving removal of stent(s). [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Liver Function Tests (LFT's) improvement at month 1 compared to baseline and at month 24 compared to removal of last stent (applicable for subjects who had not been re-stented at time of month 24 visit). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Health Economic Endpoint [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Number of outpatient procedures

  • Health Economic Endpoint [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Number of hospitalizations

  • Health Economic Endpoint [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Duration of hospitalizations

  • Health Economic Endpoint [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Length of procedures

  • Health Economic Endpoint [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Number of devices


Estimated Enrollment: 164
Study Start Date: September 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543256

Contacts
Contact: Erin Leckrone 651-582-4908 erin.leckrone@bsci.com
Contact: Andrea Burbage 508-683-4387 andrea.burbage@bsci.com

Locations
Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Michael Bourke, MD    61296891536    michael@citywestgastro.com.au   
Principal Investigator: Michael Bourke, MD         
Austria
Allgemeines Krankenhaus AKH Recruiting
Vienna, Austria, A-1090
Contact: Andreas Puespoek, MD    431414004375    andreas.puespoek@meduniwien.ac.at   
Principal Investigator: Andreas Puespoek, MD         
Belgium
Erasme Hospital Not yet recruiting
Brussels, Belgium, 1070
Contact: Jacques Deviere, MD    3225553622    jacques.deviere@erasme.ulb.ac.be   
Principal Investigator: Jacques Deviere, MD         
Canada, Quebec
CHUM - Hopital Saint-Luc Recruiting
Montreal, Quebec, Canada, H2X 3J4
Contact: Andre Roy, MD    5148908000 ext 36146    andre.roy.chum@ssss.gouv.qc.ca   
Principal Investigator: Andre Roy, MD         
France
Hopital Edouard Herriot Recruiting
Lyon, France, 69437
Contact: Thierry Ponchon, MD    0033472110146    thierry.ponchon@chu-lyon.fr   
Principal Investigator: Thierry Ponchon, MD         
Germany
Evangelisches Krankenhaus Dusseldorf Recruiting
Dusseldorf, Germany, D-40217
Contact: Horst Neuhaus, MD    004921191605    medizinischeklinik@evk-duesseldorf.de   
Principal Investigator: Horst Neuhaus, MD         
Hong Kong
Prince of Wales Hospital Not yet recruiting
Shatin, New Territories, Hong Kong
Contact: James Lau, MD    85226321411    laujyw@surgery.cuhk.edu.hk   
Principal Investigator: James Lau, MD         
India
Asian Institute of Gastroenterology Recruiting
Hyderabad, India, 500 082
Contact: D.Nageshwar Reddy, MD    4023378888    aigindianinfo@yahoo.co.in   
Principal Investigator: D.Nageshwar Reddy, MD         
Italy
Policlinico Universitario Agostino Gemelli Recruiting
Rome, Italy, 00168
Contact: Guido Costamagna, MD    39063291342    gcostamagna@rm.unicatt.it   
Principal Investigator: Guido Costamagna, MD         
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, CE, Netherlands, 3015
Contact: Marco Bruno, MD    310107035946      
Principal Investigator: Marco Bruno, MD         
Sweden
Karolinska Universitets Sjukhuset Not yet recruiting
Stockholm, Sweden, S-14186
Contact: Urban Arnelo, MD    46858586937    urban.arnelo@ki.se   
Principal Investigator: Urban Arnelo, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: D.Nageshwar Reddy, MD Asian Institute of Gastroenterology
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01543256     History of Changes
Other Study ID Numbers: CDM00047682
Study First Received: February 14, 2012
Last Updated: February 4, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Italy: Ministry of Health
Netherlands: Dutch Health Care Inspectorate

Keywords provided by Boston Scientific Corporation:
benign biliary strictures secondary to chronic pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Constriction, Pathologic
Pancreatitis, Chronic
Cholestasis
Pancreatic Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014