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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03259581
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Bilirubinemia Device: Transarterial chemoembolization Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

Arm Intervention/treatment
Experimental: Transarterial chemoembolization
Transarterial chemoembolization
Device: 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.




Primary Outcome Measures :
  1. Procedure related adverse events [ Time Frame: 1 month ]
    Percentage of adverse events following TACE


Secondary Outcome Measures :
  1. Radiologic Response [ Time Frame: 1 month ]
    mRECIST response after TACE

  2. Progression free survival [ Time Frame: 1, 3, 6, 12, 18, and 24 months ]
    Liver PFS and overall PFS

  3. Overall survival [ Time Frame: 24 months ]
    Overall survival

  4. Change in Model for end stage liver disease (MELD) [ Time Frame: 7 and 30 days ]
    Change in MELD (MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43) score at 7 and 30 days post TACE

  5. Change in Child Pugh score [ Time Frame: 7 and 30 days ]
    Change in Child Pugh score at 7 and 30 days post TACE



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259581


Contacts
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Contact: Shamar J Young, MD 612-626-5388 youn1862@umn.edu
Contact: Mary Schooley, RN 612-624-8518 mschoole10@umphysicians.umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Nichole Kent    612-624-6904    simme033@umn.edu   
Principal Investigator: Shamar Young, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03259581     History of Changes
Other Study ID Numbers: STUDY00000554
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
transarterial chemoembolization

Additional relevant MeSH terms:
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Bilirubin
Carcinoma, Hepatocellular
Hyperbilirubinemia
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pathologic Processes
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs