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

Primary Purpose

Malignant Biliary Strictures

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Biliary Strictures focused on measuring Malignant strictures of the main biliary duct

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Catholic University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ComVi biliary stent

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 19, 2011
Last Updated
October 20, 2011
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT01457105
Brief Title
Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent
Official Title
PARTIALLY COVERED NITINOL "ComVi" STENT FOR PALLIATION OF MALIGNANT NON HILAR BILIARY OBSTRUCTION
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Biliary Strictures
Keywords
Malignant strictures of the main biliary duct

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ComVi biliary stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)
Intervention Description
Metal stents placement in the main biliary duct during ERC
Primary Outcome Measure Information:
Title
patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Catholic University
City
Rome
State/Province
RM
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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