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

NCT ID: NCT03259581

Last Updated: 2022-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2022-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma Bilirubinemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transarterial chemoembolization

Transarterial chemoembolization

Group Type EXPERIMENTAL

Transarterial chemoembolization

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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2016LS137

Identifier Type: -

Identifier Source: org_study_id

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