Prospective Study Comparing Lipiodol Plus Ethanol Solution Compared With Drug-Eluting Beads for Trans-arterial Chemoembolization of Liver in Treatment of Hepatocellular Carcinoma
This is a randomized prospective study with two arms, Drug-Eluting Beads with doxorubicin
(DEB) and lipiodol ethanol mixture (LEM), with the goal to show non-inferiority of LEM,
which if true will facilitate a simple alternative to DEBs. Patients will be randomized to
one arm of the study and will remain in that arm if they need to have more embolization in
the future. Both of the mentioned methods (DEB and LEM) fall within the standard of care.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Post-Embolization Syndrome
Count of patients with post-embolizaation syndrome reported which includes fatigue, anorexia, nausea, fever.
Week 6 Post Intervention
Yes
Erik Cressman, M.D.
Principal Investigator
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
2011LS117
NCT01489410
January 2012
December 2016
Name | Location |
---|---|
Masonic Cancer Center, University of Minnesota | Minneapolis, Minnesota 55455 |