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Comparison of Liver and Renal Function After TACE for PHC With Iso-osmolar and Low-osmolar Contrast Media


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Primary Hepatocellular Carcinoma

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Trial Information

Comparison of Liver and Renal Function After TACE for PHC With Iso-osmolar and Low-osmolar Contrast Media


This was a prospective, randomized, single centre, single-blind study. Patients were
randomized (1:1) to use Low-osmolar contrast media or iso-osmolar contrast media for TACE.

On the morning of 2th and 5th days after TACE, a hematologic check was performed, the
hematologic check including serum creatinine, blood urea nitrogen, direct bilirubin,
indirect bilirubin, alanine aminotransferase, aspartate aminotransferase,
γ-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase, cholinesterase. Then,
comparing them with the data before TACE.


Inclusion Criteria:



- 18-75 years;

- PHC that could not be treated with surgery;

- Patients with clear consciousness，Cooperation;

- Informed consent: authorization and signature.

Exclusion Criteria:

- Preexisting dialysis;

- Known hypersensitivity to the contrast media;

- Complete portal vein thrombosis (main trunk or both branches);

- With severe cardiovascular or renal disease;

- Extensive arteriovenous shunting;

- Insufficient function of the remaining liver (Child-Pugh class C).

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Change from Baseline in serum creatinine, blood urea nitrogen, direct bilirubin, indirect bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase, cholinesterase.

Outcome Time Frame:

Follow-up on the 2th and 5th days after TACE

Safety Issue:

Yes

Principal Investigator

Gao-Jun Teng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical School,Southeast University

Authority:

China: Food and Drug Administration

Study ID:

320982198703092517

NCT ID:

NCT01563484

Start Date:

March 2012

Completion Date:

September 2012

Related Keywords:

  • Primary Hepatocellular Carcinoma
  • Primary Hepatocellular Carcinoma(HCC)
  • Transarterial chemoembolization (TACE)
  • Liver function
  • Renal function
  • Carcinoma
  • Carcinoma, Hepatocellular

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