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

Not Applicable

Withdrawn

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Lipiodol Ethanol Mixture; Drug: Drug-Eluting Beads (DEB) with Doxorubicin

• Registration Number: NCT01489410
• Lead Sponsor: University of Minnesota

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

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-07
• Study First Posted: 2011-12-09
• Study Start: 2012-10
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lipiodol Ethanol Mixture (LEM)	Lipiodol Ethanol Mixture	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.
Drug-Eluting Beads with Doxorubicin	Drug-Eluting Beads (DEB) with Doxorubicin	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients with Post-Embolization Syndrome	Week 6 Post Intervention	Count of patients with post-embolizaation syndrome reported which includes fatigue, anorexia, nausea, fever.

Secondary Outcome Measures

Name	Time	Method
Changes in Quality of Life	Baseline and Week 6 After Intervention	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).
Patients with Encephalopathy After Embolization	Week 6 Post Intervention	Count of patients who had encephalopathy after embolization.
Imaging Response	Week 6 Post Intervention	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.
Overall Survival	Week 6 After Intervention	Determined by date of death or date censored.
Comparison of Liver Function Tests Results	Day 0 and Week 6 Post Intervention	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.
Number of Patients with Successful Liver Transplant	Week 6 After Intervention

Trial Locations

Locations (1)

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States