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Comparison of Liver and Renal Function After Transarterial Chemoembolization for Primary Hepatocellular Carcinoma With Iso-osmolar Contrast Media and Low Osmolar Contrast Media

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01563484
Enrollment
50
Registered
2012-03-27
Start date
2012-03-31
Completion date
2012-09-30
Last updated
2012-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hepatocellular Carcinoma

Keywords

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

Brief summary

Primary Hepatocellular Carcinoma (PHC) is one of the most common malignant tumors in the world. In men is the fifth most frequently diagnosed cancer worldwide but the second most frequent cause of cancer death. In women, it is the seventh most commonly diagnosed cancer and the sixth leading cause of cancer death. An estimated 748,300 new liver cancer cases and 695,900 cancer deaths occurred worldwide in 2008. Half of these cases and deaths were estimated to occur in China. Surgical resection and liver transplantation can be curative treatment options, but less than 20% of PHC patients are candidates for surgery. The prognosis of patients with unresectable PHC is poor; if left untreated, the median survival is less than 6 months. Since transarterial chemoembolization (TACE) was introduced as a palliative treatment in patients with unresectable HCC, it has become one of the most common forms of interventional therapy. However, the possibility of treatment-related complication may offset the survival benefit, especially by the worsening of liver functions.TACE increases several parameters of hepatic cytolysis and decreases the metabolic activity of the liver. Such a deterioration of liver function due to ischemia following TACE may result in liver failure, or even death. TACE also may have an adverse effect on the kidney. Radiographic contrast medium is used to obtain the hepatogram before TACE. It has been shown that the use of contrast medium increases the risk of renal failure, especially the low-osmolar contrast media. The aim of this trials was to compare the change of liver and renal function after TACE for HCC of iso-osmolar contrast media with that of low-osmolar contrast media.

Detailed description

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.

Interventions

None listed

Sponsors

Li Chen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Change from Baseline in serum creatinine, blood urea nitrogen, direct bilirubin, indirect bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase, cholinesterase.Follow-up on the 2th and 5th days after TACE

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026