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Prospective Study Comparing Lipiodol Plus Ethanol Solution Compared With Drug-Eluting Beads for Trans-arterial Chemoembolization of Liver in Treatment of Hepatocellular Carcinoma


N/A
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Post-Embolization Syndrome

Outcome Description:

Count of patients with post-embolizaation syndrome reported which includes fatigue, anorexia, nausea, fever.

Outcome Time Frame:

Week 6 Post Intervention

Safety Issue:

Yes

Principal Investigator

Erik Cressman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2011LS117

NCT ID:

NCT01489410

Start Date:

January 2012

Completion Date:

December 2016

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota  55455