Clinical Trial: Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction
Brief Summary: The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.
Detailed Summary:
Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration.
The aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.
Sponsor: Samsung Medical Center
Current Primary Outcome: duration of stent patency [ Time Frame: From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- overall survival [ Time Frame: From the date of randomization until the date of death from any cause, assessed upto 12 months ]
- stent occlusion rate [ Time Frame: From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months ]
- stent related complication [ Time Frame: From the date of randomization until the date of first documented stent related complication, assessed up to 12 months ]
Original Secondary Outcome: Same as current
Information By: Samsung Medical Center
Dates:
Date Received: September 30, 2014
Date Started: October 2014
Date Completion: October 2016
Last Updated: February 10, 2015
Last Verified: September 2014
