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Spots Global Cancer Trial Database for Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)

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Trial Identification

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

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

Study ID: NCT02460432

Study Description

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.

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

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

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

Gangnam Severance Hospital, Seoul, , Korea, Republic of

Contact Details

Name: Dong Ki Lee, Ph.D MD

Affiliation: Gangnam Severance Hospital

Role: STUDY_CHAIR

Name: Kyu Taek Lee, Ph.D MD

Affiliation: Samsung Medical Center

Role: PRINCIPAL_INVESTIGATOR

Name: Sang Hyub Lee, Ph.D MD

Affiliation: Seoul National University Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Don Haeng Lee, Ph.D MD

Affiliation: In Ha University Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Jung Sik Choi, Ph.D MD

Affiliation: Inje University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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