NCT01041612

Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Taewoong Medical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer of Bile Duct
• Pancreatic Cancer

Interventions

Type	Name	Description
DEVICE	PTFE Covered ComVi [full covered] Biliary Stent	The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.
DEVICE	PTFE Covered ComVi [full covered] Biliary Stent	The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-01-01
• Last updated: 2016-10-21

Locations

13 sites across 2 countries: Japan, South Korea