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OpenTrials
Completed

NCT Number: NCT01457105

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

self-expandable metal stents for palliation of malignant biliary strictures

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Key information

Conditions

Malignant Biliary Strictures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University

Rome, RM, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)

Device

Metal stents placement in the main biliary duct during ERC

Primary outcomes

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

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 21, 2011
Registry last updated
Oct 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.