Safety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin
NCT03259581 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2022-03-21
Summary
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.
Conditions
- Hepatocellular Carcinoma
- Bilirubinemia
Interventions
- COMBINATION_PRODUCT
-
Transarterial chemoembolization
Delivery of lipiodol, chemotherapy (Deoxyrubicin), and particles (embosphere particles) to the arteries feeding hepatocellular carcinoma. While both chemotherapy and particles are delivered this is a single procedure in which the chemotherapy is delivered followed immediately by particles.
Sponsors & Collaborators
- lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-02
- Primary Completion
- 2021-12-31
- Completion
- 2022-02-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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