Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent

PARTIALLY COVERED NITINOL "ComVi" STENT FOR PALLIATION OF MALIGNANT NON HILAR BILIARY OBSTRUCTION

NCT01457105•Catholic University of the Sacred Heart

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Catholic University

Rome, RM, Italy

Key Dates

Start Date

November 1, 2006

Primary Completion Date

June 1, 2009

Completion Date

June 1, 2009

Last Updated

October 21, 2011

Enrollment

ACTUAL participants

Conditions

Malignant Biliary Strictures

Interventions

Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)

DEVICE