Status:
WITHDRAWN
Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma
Lead Sponsor:
University of Minnesota
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chemoembolization of hepatocellular carcinoma lesions is an accepted and frequently used method for the palliative or curative treatment of these lesions. These attempts are being made to make these p...
Detailed Description
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 fac...
Eligibility Criteria
Inclusion
- Child-Pugh class A or B
- Biopsy proven HCC or hypervascular mass per European Association for the Study of the Liver (EASL) criteria
- Patient not a candidate for surgical resection or percutaneous ablation
- age \> 18 years old and able to consent
Exclusion
- Child-Pugh class C
- Model for End-Stage Liver Disease (MELD) score \>16
- Extrahepatic disease
- Bilateral or main portal vein thrombus
- Total bilirubin \> 2.2
- Serum albumin \< 2.6
- Life expectancy \< 2 months
- Uncorrected INR \> 2
- Eastern Cooperative Oncology Group (ECOG) status \> 2
- Tumor burden \> 50% liver volume
- Hepatofugal portal venous flow
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01489410
Start Date
October 1 2012
End Date
March 1 2014
Last Update
August 31 2017
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455