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

Catholic University of the Sacred Heart

Status: Completed

Conditions: Malignant Biliary Strictures

Treatments: Device: Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)

Study type: Interventional

Funder types: Other

Identifiers

NCT01457105

A/1531/05

Details and patient eligibility

About

self-expandable metal stents for palliation of malignant biliary strictures

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

ComVi biliary stent

Experimental group

Treatment:

Device: Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)