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

Malignant Biliary Strictures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457105
• Other study ID #: A/1531/05
• Status: Completed
• Phase: N/A
• First received: October 19, 2011
• Last updated: October 20, 2011
• Start date: November 2006
• Est. completion date: June 2009

Study information

• Verified date: October 2011
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

self-expandable metal stents for palliation of malignant biliary strictures

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis
• Constriction, Pathologic
• Malignant Biliary Strictures

Intervention

Device:
• Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)
Metal stents placement in the main biliary duct during ERC

Locations

Country	Name	City	State
Italy	Catholic University	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures		two years	No