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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01489410
• Other study ID #: 2011LS117
• Status: Withdrawn
• Phase: N/A
• First received: December 6, 2011
• Last updated: August 30, 2017
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: August 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 patients a better candidate for liver transplant or to provide palliation for their condition.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Drug-Eluting Beads (DEB) with Doxorubicin
One treatment of Drug-Eluting Beads (DEB) with Doxorubicin administered to the liver through a groin puncture site and delivered through the vessels that feed the liver (per standard of care).
• Lipiodol Ethanol Mixture
One treatment of Lipiodol Ethanol Mixture (LEM) is administered to the liver through a groin puncture site and delivered through the vessels that feed the liver (per standard of care).

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Patients with Encephalopathy After Embolization	Count of patients who had encephalopathy after embolization.	Week 6 Post Intervention
Secondary	Changes in Quality of Life	Changes (noted as a score of 0 [not at all] to 4 [very much]; total score ranges from 1-180) in the different aspects of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) quality of life questionnaire (a 45-item self-report instrument designed to measure health-related quality of life in patients with hepatobiliary cancers).	Baseline and Week 6 After Intervention
Secondary	Comparison of Liver Function Tests Results	List of results for alpha-fetoprotein (AFP), albumin (Alb), alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), blood urea nitrogen (BUN), creatinine (Cr), glomerular filtration rate (GFR), Bilirubin (T, D), platelets (Plt), international normalized ratio (INR - prothrombin time), Child-Pugh score.	Day 0 and Week 6 Post Intervention
Secondary	Imaging Response	Determined by European Association for the Study of the Liver (EASL) criteria a set of non-invasive criteria for HCC in cirrhotic patients. The diagnosis is established if two imaging modalities (US, CT, magnetic resonance imaging (MRI)) show a coincidental nodule with arterial hypervascularization regardless of AFP levels, or if a single modality shows a lesion when the AFP levels are more than 400 ng/ml. Histologic diagnosis is required if the patient is non-cirrhotic or if the lesions are smaller than 2 cm.	Week 6 Post Intervention
Secondary	Number of Patients with Successful Liver Transplant		Week 6 After Intervention
Secondary	Overall Survival	Determined by date of death or date censored.	Week 6 After Intervention