Malignant Biliary Strictures
Conditions
Keywords
Malignant strictures of the main biliary duct
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.
Interventions
DEVICEEndoscopic retrograde cholangiography (ERC) (ComVi biliary stent)
Metal stents placement in the main biliary duct during ERC
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures | two years |
Countries
Italy
Outcome results
None listed