Clinical Trial: Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief Summary: 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.
Detailed Summary:
Sponsor: Taewoong Medical Co., Ltd.
Current Primary Outcome: Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange [ Time Frame: one year ]
Original Primary Outcome:
- Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange [ Time Frame: one year ]
- Presence of cholangitis with no evidence of stent occlusion [ Time Frame: one year ]
Current Secondary Outcome: Death of patients [ Time Frame: one year ]
Original Secondary Outcome: Same as current
Information By: Taewoong Medical Co., Ltd.
Dates:
Date Received: December 28, 2009
Date Started: January 2010
Date Completion:
Last Updated: October 19, 2016
Last Verified: October 2016
