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Prospective Randomized Trial Comparing Covered Metal Stents Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction: A Multi-nation, Multi-center Study
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, above and across the sphincter of Oddi, in malignant bile duct obstruction.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Gifu University
Gifu, Japan
Onomichi General Hospital
Onomichi, Japan
Teine-Keijinkai Hospital
Sapporo, Japan
The University of Tokyo
Tokyo, Japan
Toho University
Tokyo, Japan
Tokyo Medical University
Tokyo, Japan
Yamaguchi University
Ube, Japan
Soon Chun Hyang University School of Medicine
Bucheon-si, South Korea
Soon Chun Hyang University School of Medicine
Cheonan, South Korea
Catholic University of Daegu School of Medicine
Daegu, South Korea
Start Date
January 1, 2010
Primary Completion Date
September 1, 2012
Completion Date
September 1, 2012
Last Updated
October 21, 2016
120
ACTUAL participants
PTFE Covered ComVi [full covered] Biliary Stent
DEVICE
PTFE Covered ComVi [full covered] Biliary Stent
DEVICE
Lead Sponsor
Taewoong Medical Co., Ltd.
NCT04550494
NCT05053971
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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