Clinical trial NCT01543256: WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Stricture
Keywords: benign biliary strictures secondary to chronic pancreatitis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Stricture Resolution
timeFrame: After 12-month stenting period through 24 month follow-up (approximately 12 months)
Secondary outcomes:
measure: Serious Adverse Events Related to the Device or Procedure
timeFrame: Initial stent placement procedure to 24 month follow-up
measure: Number of ERCP Procedures Through 24 Months After Initial Stent Placement.
timeFrame: Initial stent placement procedure to 24 month follow-up
measure: Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)
timeFrame: Initial stent placement procedure
measure: Length of Stent Placement and Removal Procedures
timeFrame: Initial stent placement procedure to 24 month follow-up
measure: Number of Stents Placed
timeFrame: Initial stent placement procedure to 24 month follow-up
Other outcomes:
Locations:
city: Newtown
country: Australia
facility: Royal Prince Alfred Medical Center
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus AKH
city: Brussels
country: Belgium
facility: Erasme Hospital
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Montreal
country: Canada
facility: CHUM - Hopital Saint-Luc
state: Quebec
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Dusseldorf
country: Germany
facility: Evangelisches Krankenhaus Dusseldorf
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
state: VR
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: CE
city: Stockholm
country: Sweden
facility: Karolinska Universitets Sjukhuset
Study officials:
affiliation: Asian Institute of Gastroenterology
name: D.Nageshwar Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.