Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma

University of Minnesota (UMN)

Status: Withdrawn

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Drug-Eluting Beads (DEB) with Doxorubicin; Drug: Lipiodol Ethanol Mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT01489410

2011LS117

Details and patient eligibility

About

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.

Full 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 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Drug-Eluting Beads with Doxorubicin

Active Comparator group

Description:

Drug-Eluting Beads (DEB) with Doxorubicin is administered via beads that release it to the liver through a groin puncture site and delivered via catheter through the vessels that feed the liver.

Treatment:

Drug: Drug-Eluting Beads (DEB) with Doxorubicin

Lipiodol Ethanol Mixture (LEM)

Active Comparator group

Description:

Lipiodol Ethanol Mixture (LEM) is administered to the liver through a groin puncture site and delivered via catheter through the vessels that feed the liver.

Treatment:

Drug: Lipiodol Ethanol Mixture