Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent (MIRAII)

Jong Taek, Lee

Status: Terminated

Conditions: Biliary Stricture; Malignant Neoplasms

Treatments: Device: biliary stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01413386

MIRA-001

Details and patient eligibility

About

Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.

Full description

Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior to common covered metal biliary stent (Niti-S Biliary Stent_ComVi type)in their patency rate and safety at the 6 months after stenting.

Enrollment: 74 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient who submitted a written informed consent for the this trial, and 18 ~ 90 years old
• Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
• Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis
• Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly
• Patient who have life expectancy at least longer than 3 months (Karnofsky score >60%)

Exclusion criteria

• Patient who previously had surgical biliary drainage
• Patient who carrying bleeding disorder
• Patient who have combined Hilar and/or intra-hepatic duct cancer
• Patient who is improper to endoscopic treatment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Paclitaxel Eluting Covered Metal Stent

Experimental group

Treatment:

Device: biliary stent

Covered Metal Stent

Active Comparator group

Treatment:

Device: biliary stent