Status:
COMPLETED
Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Malignant Biliary Strictures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
self-expandable metal stents for palliation of malignant biliary strictures
Detailed Description
The ComVi biliary stent (Taewoong Medical Inc., Seoul, Korea), is a covered metallic stent with a expanded polytetrafluoroethylene (e-PTFE) membrane sandwiched between two wire layers and has a weaker...
Eligibility Criteria
Inclusion
- Patients with malignant stenosis at the middle or lower third of the common bile duct inoperable and/or unresectable.
- Patients without liver metastases and 6 months life expectancy
- Patients at the first attempt of endoscopic biliary drainage.
- Negative history for biliary tract surgery.
Exclusion
- Patients with ampullary cancer.
- Patients with hilar and/or intra-hepatic ducts malignancy.
- Patients with haemobilia.
- Patients with acute cholangitis at the time of stenting.
- Patients with previous percutaneous, endoscopic or surgical biliary drainage.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01457105
Start Date
November 1 2006
End Date
June 1 2009
Last Update
October 21 2011
Active Locations (1)
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1
Catholic University
Rome, RM, Italy, 00168