Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma
| Status: | Withdrawn |
|---|---|
| Conditions: | Liver Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/1/2017 |
| Start Date: | October 2012 |
| End Date: | March 2014 |
Prospective Study Comparing Lipiodol Plus Ethanol Solution Compared With Drug-Eluting Beads for Trans-arterial Chemoembolization of Liver in Treatment of Hepatocellular Carcinoma
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 patients a better candidate for liver transplant or to provide palliation
for their condition.
method for the palliative or curative treatment of these lesions. These attempts are being
made to make these patients a better candidate for liver transplant or to provide palliation
for their condition.
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.
(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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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