Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent
Not Applicable
Completed
- Conditions
- Malignant Biliary Strictures
- Interventions
- Device: Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)
- Registration Number
- NCT01457105
- Lead Sponsor
- Catholic University of the Sacred Heart
- 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 axial force than other stents.
Patients with middle-distal malignant biliary stricture and with symptoms as jaundice, itching and pain.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ComVi biliary stent Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent) -
- Primary Outcome Measures
Name Time Method patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures two years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Catholic University
🇮🇹Rome, RM, Italy