Safety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin

University of Minnesota (UMN)

Status and phase: Completed; Phase 1

Conditions: Bilirubinemia; Hepatocellular Carcinoma

Treatments: Combination Product: Transarterial chemoembolization

Study type: Interventional

Funder types: Other

Identifiers

NCT03259581

2016LS137

Details and patient eligibility

About

The aim of this study is to evaluate the safety of selective transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but relatively normal direct bilirubin.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hepatocellular carcinoma (HCC)
• Direct or conjugated bilirubin < 3 mg/dl
• Total bilirubin > 3 mg/dl
• Willing and able to provide informed consent
• >18 years of age

Exclusion criteria

• Currently pregnant
• Patients who are surgical or ablation candidates as determined by multidisciplinary hepatobiliary tumor conference.
• Arterial anatomy which would preclude selective transarterial chemoembolization
• Patients who have a INR or platelet count which are not correctable to <1.8 and >35,000 respectively
• Patients with extrahepatic metastases
• Patients with portal vein invasion

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Transarterial chemoembolization

Experimental group

Description:

Transarterial chemoembolization

Treatment:

Combination Product: Transarterial chemoembolization