WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

Biliary Stricture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543256
• Other study ID #: CDM00047682
• Status: Completed
• Phase: N/A
• Start date: September 18, 2012
• Est. completion date: September 21, 2020

Study information

• Verified date: December 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: September 21, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Stricture
• Cholestasis
• Constriction, Pathologic
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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")
• 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.

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Medical Center	Newtown	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Austria	Allgemeines Krankenhaus AKH	Vienna
Belgium	Erasme Hospital	Brussels
Belgium	UZ Gasthuisberg	Leuven
Canada	CHUM - Hopital Saint-Luc	Montreal	Quebec
France	Hopital Edouard Herriot	Lyon
Germany	Evangelisches Krankenhaus Dusseldorf	Dusseldorf
Hong Kong	Prince of Wales Hospital	Shatin	New Territories
India	Asian Institute of Gastroenterology	Hyderabad
Italy	Policlinico Universitario Agostino Gemelli	Rome
Italy	Azienda Ospedaliera Universitaria Integrata di Verona	Verona	VR
Netherlands	Erasmus Medical Center	Rotterdam	CE
Sweden	Karolinska Universitets Sjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Stents Placed	Number of stents placed throughout study to 24 month follow-up	Initial stent placement procedure to 24 month follow-up