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

Catholic University of the Sacred Heart70 enrolled

Overview

self-expandable metal stents for palliation of malignant biliary strictures

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Biliary Strictures

Interventions

Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)DEVICE

Metal stents placement in the main biliary duct during ERC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures

Time frame: two years

Data from ClinicalTrials.gov

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