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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
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")
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.
Royal Prince Alfred Medical Center
Newtown, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Allgemeines Krankenhaus AKH
Vienna, Austria
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.
Time frame: After 12-month stenting period through 24 month follow-up (approximately 12 months)
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.
Time frame: 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.
Time frame: 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.
Time frame: Initial stent placement procedure
Length of Stent Placement and Removal Procedures
Length of stent placement procedures and stent removal procedures.
Time frame: Initial stent placement procedure to 24 month follow-up
Number of Stents Placed
Number of stents placed throughout study to 24 month follow-up
Time frame: Initial stent placement procedure to 24 month follow-up
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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
...and 4 more locations