WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

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.

Study Overview

• Status: Completed
• Conditions: Biliary Stricture
• Intervention / Treatment: Device: Commercially available Plastic Stent Per Investigator preference; Device: WallFlex™ Biliary RX Fully Covered Stent System RMV

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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. ("RMV" in intervention name indicates "removable")
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 12-month stenting period through 24 month follow-up (approximately 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Initial stent placement procedure
Length of Stent Placement and Removal Procedures	Length of stent placement procedures and stent removal procedures.	Initial stent placement procedure to 24 month follow-up
Number of Stents Placed	Number of stents placed throughout study to 24 month follow-up	Initial stent placement procedure to 24 month follow-up

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: D.Nageshwar Reddy, MD, Asian Institute of Gastroenterology

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2012
• Primary Completion (Actual): September 21, 2020
• Study Completion (Actual): September 21, 2020

Study Registration Dates

• First Submitted: February 14, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: benign biliary strictures secondary to chronic pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Pancreatic Diseases; Bile Duct Diseases; Constriction, Pathologic; Pancreatitis; Pancreatitis, Chronic; Cholestasis
• Other Study ID Numbers: CDM00047682

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No