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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
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.
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
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