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

Not Applicable

Completed

• Conditions: Pancreatic Neoplasms; Biliary Obstruction; Biliary Neoplasms
• Interventions: Device: Paclitaxel-eluting metal Stent; Device: Covered Metal Stent

• Registration Number: NCT02460432
• Lead Sponsor: Taewoong Medical Co., Ltd.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-02
• Primary Completion: 2016-12-26
• Study Completion: 2016-12-26
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel-eluting metal Stent	Paclitaxel-eluting metal Stent	Niti-S Mira-Cover III Biliary Stent (TaeWoong Medical Co., Ltd. Korea)
Covered Metal Stent	Covered Metal Stent	ComVi Biliary Covered Stent (TaeWoong Medical Co., Ltd. Korea)

Primary Outcome Measures

Name	Time	Method
Cumulative stent patency during 6months after stent placement	6 month	Stent patency is defined as absence of stent obstruction and confirmed by computed tomography (CT) or ERCP.

Secondary Outcome Measures

Name	Time	Method
Stent migration	6 month	Stent migration is defined as an obvious dislodgement from the intended and original implant position and confirmed by radiography, CT, or ERCP.
Secondary stent insertion due to recurrent biliary obstruction	6 month
Mean survival	6 month
Adverse events	6 month

Trial Locations

Locations (5)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Bokji-ro Busanjin-gu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Haehak-ro Jongno-gu, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Irwon-Dong, Gangnam-Gu, Korea, Republic of

In Ha University Hospital; 🇰🇷 Incheon, Inhang-ro Jung-gu, Korea, Republic of