Clinical trial NCT01014390: WallFlex Biliary Fully Covered (FC) Benign Stricture Study
Official title: A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Biliary Stricture
Keywords: benign biliary strictures secondary to chronic pancreatitis/post abdominal surgery/post liver transplant
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-11-17
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.


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 or prior liver transplantation or prior other abdominal surgery (to include cholecystectomy)
* Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by cholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange of prior plastic stent(s) for management of benign stricture

Exclusion Criteria:

General:

* Placement of the stent in strictures that cannot be dilated enough to pass the delivery system
* Placement of the stent in a perforated duct
* Placement of the stent in very small intrahepatic ducts
* Patients for whom endoscopic techniques are contraindicated
* Biliary stricture of malignant etiology
* Biliary stricture of benign etiology other than chronic pancreatitis or liver transplant anastomosis or other abdominal surgery
* Stricture within 2 cm of duct bifurcation
* Symptomatic duodenal stenosis (with gastric stasis)
* Prior biliary self-expanding metal stent
* Suspected stricture ischemia based on imaging of hepatic artery occlusion or endoscopic evidence of biliary cast syndrome
* Known bile duct fistula
* Known sensitivity to any components of the stent or delivery system
* Participation in another investigational study within 90 days prior to consent or during the study

Additional Specific to Chronic Pancreatitis Patients:

* Developing obstructive biliary symptoms associated with an attack of acute pancreatitis

Additional Specific to Post-Abdominal Surgery Patients:

* History of hepatectomy
* History of liver transplant

Additional Specific to Liver Transplant Patients:

* Live donor transplantation

Primary outcomes:
measure: Stent Removability
timeFrame: At stent removal
Secondary outcomes:
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Brussels
country: Belgium
facility: ULB Erasme Hospital
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
state: Quebec
city: Montreal
country: Canada
facility: MUHC - McGill University
state: Quebec
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Dusseldorf
country: Germany
facility: Evangelischen Krankenhaus
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
city: Rome
country: Italy
facility: Università Cattolica del Sacro Cuore Policlinico A. Gemelli
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Girona
country: Spain
facility: Hospital Universitari Doctor Josep Trueta
state: Catalunya
Study officials:
References:
citation: Deviere J, Nageshwar Reddy D, Puspok A, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, Gonzalez-Huix Llado F, Barkun AN, Kortan PP, Navarrete C, Peetermans J, Blero D, Lakhtakia S, Dolak W, Lepilliez V, Poley JW, Tringali A, Costamagna G; Benign Biliary Stenoses Working Group. Successful management of benign biliary strictures with fully covered self-expanding metal stents. Gastroenterology. 2014 Aug;147(2):385-95; quiz e15. doi: 10.1053/j.gastro.2014.04.043. Epub 2014 May 4.
citation: Poley JW, Ponchon T, Puespoek A, Bruno M, Roy A, Peetermans J, Rousseau M, Lepilliez V, Dolak W, Tringali A, Blero D, Carr-Locke D, Costamagna G, Deviere J; Benign Biliary Stenoses Working Group. Fully covered self-expanding metal stents for benign biliary stricture after orthotopic liver transplant: 5-year outcomes. Gastrointest Endosc. 2020 Dec;92(6):1216-1224. doi: 10.1016/j.gie.2020.04.078. Epub 2020 May 15.
citation: Tringali A, Reddy DN, Ponchon T, Neuhaus H, Llado FG, Navarrete C, Bruno MJ, Kortan PP, Lakhtakia S, Peetermans J, Rousseau M, Carr-Locke D, Deviere J, Costamagna G; Benign Biliary Stenoses Working Group. Treatment of post-cholecystectomy biliary strictures with fully-covered self-expanding metal stents - results after 5 years of follow-up. BMC Gastroenterol. 2019 Dec 12;19(1):214. doi: 10.1186/s12876-019-1129-3.
citation: Lakhtakia S, Reddy N, Dolak W, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, Gonzalez-Huix Llado F, Kortan PP, Peetermans J, Rousseau M, Costamagna G, Deviere J; Benign Biliary Stenoses Working Group. Long-term outcomes after temporary placement of a self-expanding fully covered metal stent for benign biliary strictures secondary to chronic pancreatitis. Gastrointest Endosc. 2020 Feb;91(2):361-369.e3. doi: 10.1016/j.gie.2019.08.037. Epub 2019 Sep 5.