Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent (MIRA-cover)

Taewoong Medical

Status: Completed

Conditions: Biliary Stricture; Malignant Neoplasms

Treatments: Device: Biliary stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01512563

MIRA-cover

Details and patient eligibility

About

Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.

Full description

Paclitaxel covered metal biliary stent(Mira-Cover Biliary Stent) extents their patency rate comparing to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent.

Enrollment: 106 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient who is inoperable and/or unresectable cases of pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
• Among patient of a.,Patient who previously had surgical biliary drainage of plastic stent have eligibility

Exclusion criteria

• Patient who have life expectancy under 3 months
• Patient who have severe metastasis of Liver or whole body
• Patient who previously had surgical biliary drainage

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

106 participants in 2 patient groups

Paclitaxel ElutingCovered Metal Stent

Experimental group

Treatment:

Device: Biliary stent

Covered Metal Stent

Active Comparator group

Treatment:

Device: Biliary stent