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

A Prospective, Randomized, Single Blind Study to Evaluate the Effectiveness and Safety Comparing Niti-S Mira-Cover III Biliary Stent With ComVi Biliary Covered Stent in Patients With Malignant Biliary Obstruction

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.

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.

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.