Study of the WallFlexâ„¢ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Summary
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Biliary Strictures Caused by Malignant Neoplasms
Intervention
WallFlex™ Biliary Partially-Covered Stent
Location
ULB Erasme Hospital
Brussels
Cedex 3
Belgium
1070
Status
Completed
Source
Boston Scientific Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00713427
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cholangitis, Sclerosing
Chronic inflammatory disease of the BILIARY TRACT. It is characterized by fibrosis and hardening of the intrahepatic and extrahepatic biliary ductal systems leading to bile duct strictures, CHOLESTASIS, and eventual BILIARY CIRRHOSIS.
Biliary Fistula
Abnormal passage in any organ of the biliary tract or between biliary organs and other organs.
Clonorchiasis
Infection of the biliary passages with CLONORCHIS SINENSIS, also called Opisthorchis sinensis. It may lead to inflammation of the biliary tract, proliferation of biliary epithelium, progressive portal fibrosis, and sometimes bile duct carcinoma. Extension to the liver may lead to fatty changes and cirrhosis. (From Dorland, 27th ed)
Biliary Dyskinesia
A motility disorder characterized by biliary COLIC, absence of GALLSTONES, and an abnormal GALLBLADDER ejection fraction. It is caused by gallbladder dyskinesia and/or SPHINCTER OF ODDI DYSFUNCTION.
Biliary Tract Neoplasms
Tumors or cancer in the BILIARY TRACT including the BILE DUCTS and the GALLBLADDER.
Clinical Trials
Endoscopic Treatment of Biliary Strictures After LTX: Balloon Dilatation Versus Stent Placement
Background and Study Aims: Biliary strictures are a major cause of morbidity following liver transplantation with an overall incidence between 10 and 30 %. Up to now biliary strictures wer...
Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis
Benign biliary strictures can be endoscopically treated with plastic or self-expandable metal stents (SEMS). The purpose of the prospective randomized study is to compare the safety and fe...
Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction
The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency...
Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, abo...
Confocal Endomicroscopy for Biliary Strictures -Phase I
The investigators hypothesize that the confocal endomicroscopy imaging of the biliary strictures during ERCP will differentiate between benign and malignant strictures in vivo and has incr...
PubMed Articles
Endoscopic stenting is an effective treatment option in the management of both benign biliary strictures and pancreatic ductal strictures. Plastic stents and self-expandable metal stents have been use...
Postoperative biliary strictures are the most common cause of benign biliary stricture in Western countries, secondary to either operative injury or bile duct anastomotic stricture following orthotopi...
BACKGROUND: Endoscopic retrograde cholangiopancreatography with biliary self-expanding metal stent placement is the preferred method of providing biliary drainage for pancreaticobiliary malignancies....
BACKGROUND: Benign biliary strictures are typically managed endoscopically whereby an increasing size or number of plastic stents is placed at ERCP. Stents are often changed every 3 to 4 months based...
To evaluate the effect of temporary stent graft placement in the treatment of benign anastomotic biliary strictures.
