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

NCT ID: NCT01457105

Last Updated: 2011-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-06-30

Brief Summary

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self-expandable metal stents for palliation of malignant biliary strictures

Detailed Description

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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.

Conditions

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Malignant Biliary Strictures

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ComVi biliary stent

Group Type EXPERIMENTAL

Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)

Intervention Type DEVICE

Metal stents placement in the main biliary duct during ERC

Interventions

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Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)

Metal stents placement in the main biliary duct during ERC

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Professor Guido Costamagna

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic University

Rome, RM, Italy

Site Status

Countries

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Italy

Other Identifiers

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A/1531/05

Identifier Type: -

Identifier Source: org_study_id