Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)

Taewoong Medical

Status

Completed

Conditions

Biliary Obstruction

Biliary Neoplasms

Pancreatic Neoplasms

Treatments

Device: Paclitaxel-eluting metal Stent

Device: Covered Metal Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT02460432

MIRA-003

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction.

Full description

In patients with malignant biliary obstruction, endoscopic placement of biliary stents offers similar technical success rates. Endoscopic retrograde cholangiography (ERCP)-guided stent placement has become the preferred approach to palliate malignant biliary obstruction. The major mechanisms of self-expandable metallic stent (SEMS) occlusion are tumor ingrowth, tumor overgrowth, and epithelial hyperplasia. These mechanisms provide the rationale for developing a drug-eluting stent in order to improve stent patency. Limited data exist regarding outcomes of paclitaxel-eluting stents in malignant biliary obstruction. This study is to prospectively compare the effectiveness and safety of paclitaxel-eluting covered metal stent and covered metal stent for the treatment of malignant biliary obstruction.

Enrollment

106 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age greater than or equal to 19 years of age
Malignant mid or distal biliary obstruction
Unresectable cancer
Estimated survival greater than or equal to 3 months (Karnofsky score ≥ 60)
Patient willing to provide written informed consent and comply with follow-up requirements

Exclusion criteria

Patients who had undergone surgical biliary drainage
Severe bleeding disorder (e.g. coagulopathy)
Polypoid lesion or intra-abdominal abscess
Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.