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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460432
• Other study ID #: MIRA-003
• Status: Completed
• Phase: N/A
• First received: May 26, 2015
• Last updated: April 7, 2017
• Start date: May 2015
• Est. completion date: December 26, 2016

Study information

• Verified date: April 2017
• Source: Taewoong Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 26, 2016
• Est. primary completion date: December 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Neoplasms
• Biliary Obstruction
• Biliary Tract Neoplasms
• Neoplasms
• Pancreatic Neoplasms

Intervention

Device:
• Paclitaxel-eluting metal Stent
Insertion of Niti-S Mira-Cover III Biliary Stent using ERCP
• Covered Metal Stent
Insertion of ComVi Biliary Covered Stent using ERCP

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital	Busan	Bokji-ro Busanjin-gu
Korea, Republic of	In Ha University Hospital	Incheon	Inhang-ro Jung-gu
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul	Irwon-Dong, Gangnam-Gu
Korea, Republic of	Seoul National University Hospital	Seoul	Haehak-ro Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Taewoong Medical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative stent patency during 6months after stent placement	Stent patency is defined as absence of stent obstruction and confirmed by computed tomography (CT) or ERCP.	6 month
Secondary	Stent migration	Stent migration is defined as an obvious dislodgement from the intended and original implant position and confirmed by radiography, CT, or ERCP.	6 month
Secondary	Secondary stent insertion due to recurrent biliary obstruction		6 month
Secondary	Mean survival		6 month
Secondary	Adverse events		6 month