Survival According to the Feeding Artery Obliteration by Chemoembolization for Unresectable Hepatocellular Carcinoma

Hallym University

Status: Unknown

Conditions: Transarterial Chemoembolization; Hepatocellular Carcinoma

Treatments: Procedure: Complete embolization; Procedure: Intermediate embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT01677468

2011-12-122

Details and patient eligibility

About

The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.

Full description

Subjective angiographic chemoembolization endpoints (SACE) levels were developed to standardize the embolic endpoints of transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). It determined the antegrade arterial flow and residual tumor blush as follows: I, normal-normal; II, reduced-reduced; III, reduced-none; IV, none-none. SACE level II and III indicates intermediate-levels of embolization, whereas IV indicates overembolization. The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.

Enrollment: 250 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 18
• ECOG performance status 0-2
• Hepatocellular carcinoma diagnosed histologically or clinically
• Tumor numbers of 5 or less
• No history of treatment for hepatocellular carcinoma
• Patients with informed consent

Exclusion criteria

• Extrahepatic metastasis
• Rupture of hepatocellular carcinoma
• Infiltrative hepatocellular carcinoma
• Malignancy other than hepatocellular carcinoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Intermediate embolization

Experimental group

Description:

TACE with substatsis using gelfoam

Treatment:

Procedure: Intermediate embolization

Complete embolization

Active Comparator group

Description:

TACE with complete embolization using gelfoam

Treatment:

Procedure: Complete embolization