WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

NCT01543256 | Completed Results

• 1 other identifier: CDM00047682
• Study Type: interventional
• Target: 172
• Locations: 10 countries
• Sites: 13

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.

Conditions

Biliary Stricture

Keywords

benign biliary strictures secondary to chronic pancreatitis

Outcome Measures

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.

  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

  Initial stent placement procedure to 24 month follow-up

• Number of 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)

  Initial stent placement procedure

• Length of Stent Placement and Removal Procedures

  Initial stent placement procedure to 24 month follow-up

• Number of Stents Placed

  Initial stent placement procedure to 24 month follow-up

Study Arms (2)

Metal stents

ACTIVE COMPARATOR

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

Plastic Stents

ACTIVE COMPARATOR

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

WallFlex™ Biliary RX Fully Covered Stent System RMV DEVICE

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")

Metal stents

Commercially available Plastic Stent Per Investigator preference DEVICE

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.

Plastic Stents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (14)

Royal Prince Alfred Medical Center

Newtown, New South Wales, 2042, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Allgemeines Krankenhaus AKH

Vienna, A-1090, Austria

Location

Erasme Hospital

Brussels, 1070, Belgium

Location

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

CHUM - Hopital Saint-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Evangelisches Krankenhaus Dusseldorf

Düsseldorf, D-40217, Germany

Location

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Asian Institute of Gastroenterology

Hyderabad, 500 082, India

Location

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, VR, 37134, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

Erasmus Medical Center

Rotterdam, CE, 3015, Netherlands

Location

Karolinska Universitets Sjukhuset

Stockholm, S-14186, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33741314 DERIVED

Results Point of Contact

• Title: Evelyne Ho
• Organization: Boston Scientific

Evelyne.Ho@bsci.com

+1 508-683-4140

Study Officials

• D.Nageshwar Reddy, MD

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: March 2, 2012
• Study Start: September 18, 2012
• Primary Completion: September 21, 2020
• Study Completion: September 21, 2020
• Last Updated: January 9, 2023
• Results First Posted: January 9, 2023

Record last verified: 2021-12

Locations

FR (1); AU (2); BE (2); CA (1); SE (1); IN (1); IT (2); NL (1); HK (1); DE (1)