WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

NCT ID: NCT01543256

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-18
• Study Completion Date: 2020-09-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metal stents

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

Group Type: ACTIVE_COMPARATOR

WallFlex™ Biliary RX Fully Covered Stent System RMV

Intervention Type: 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")

Plastic Stents

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

Group Type: ACTIVE_COMPARATOR

Commercially available Plastic Stent Per Investigator preference

Intervention Type: 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.

Interventions

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")

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

D.Nageshwar Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Asian Institute of Gastroenterology

Locations

Royal Prince Alfred Medical Center

Newtown, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Allgemeines Krankenhaus AKH

Vienna, , Austria

Erasme Hospital

Brussels, , Belgium

UZ Gasthuisberg

Leuven, , Belgium

CHUM - Hopital Saint-Luc

Montreal, Quebec, Canada

Hopital Edouard Herriot

Lyon, , France

Evangelisches Krankenhaus Dusseldorf

Düsseldorf, , Germany

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Asian Institute of Gastroenterology

Hyderabad, , India

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, VR, Italy

Policlinico Universitario Agostino Gemelli

Rome, , Italy

Erasmus Medical Center

Rotterdam, CE, Netherlands

Karolinska Universitets Sjukhuset

Stockholm, , Sweden

Countries

Australia; Austria; Belgium; Canada; France; Germany; Hong Kong; India; Italy; Netherlands; Sweden

References

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.

Reference Type: DERIVED

PMID: 33741314 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CDM00047682

Identifier Type: -

Identifier Source: org_study_id