WallFlex Biliary Fully Covered (FC) Benign Stricture Study

NCT ID: NCT01014390

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2017-11-30

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.

Conditions

Biliary Stricture

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WallFlex Biliary RX FC Stent System

The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.

Group Type: EXPERIMENTAL

WallFlex Biliary RX Fully Covered Stent System

Intervention Type: DEVICE

Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.

Interventions

WallFlex Biliary RX Fully Covered Stent System

Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Westmead Hospital

Westmead, New South Wales, Australia

Medical University of Vienna

Vienna, , Austria

ULB Erasme Hospital

Brussels, , Belgium

St. Michael's Hospital

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital

Montreal, Quebec, Canada

MUHC - McGill University

Montreal, Quebec, Canada

Clinica Alemana de Santiago

Santiago, , Chile

Hopital Edouard Herriot

Lyon, , France

Evangelischen Krankenhaus

Düsseldorf, , Germany

Asian Institute of Gastroenterology

Hyderabad, , India

Università Cattolica del Sacro Cuore Policlinico A. Gemelli

Rome, , Italy

Erasmus Medical Center

Rotterdam, , Netherlands

Hospital Universitari Doctor Josep Trueta

Girona, Catalonia, Spain

Countries

Australia; Austria; Belgium; Canada; Chile; France; Germany; India; Italy; Netherlands; Spain

References

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.

Reference Type: RESULT

PMID: 24801350 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32417298 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31830897 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31494135 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/?term=24801350

Successful management of benign biliary strictures with fully covered self-expanding metal stents.

Other Identifiers

CDM 00027550

Identifier Type: -

Identifier Source: org_study_id