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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Southeast University, China.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Li Chen, Southeast University, China
ClinicalTrials.gov Identifier:
NCT01563484
First received: March 20, 2012
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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.


Condition Phase
Primary Hepatocellular Carcinoma
Phase 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Liver and Renal Function After TACE for PHC With Iso-osmolar and Low-osmolar Contrast Media

Resource links provided by NLM:


Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • Change from Baseline in serum creatinine, blood urea nitrogen, direct bilirubin, indirect bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase, cholinesterase. [ Time Frame: Follow-up on the 2th and 5th days after TACE ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
low-osmolar contrast media
Patients undergo TACE of low-osmolar contrast media on day 1.
iso-osmolar contrast media
Patients undergo TACE of iso-osmolar contrast media on day 1.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This test chooses the patients with unresectable PHC. Then divide them into two groups.In one group,patients underwent a transarterial infusion of ioversol injection(a kind of low-osmolar contrast media).In the other group,patients underwent a transarterial infusion of iodixanol injection(a kind of iso-osmolar contrast media).

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563484

Locations
China, Jiangsu
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Li Chen
Investigators
Principal Investigator: Gao-Jun Teng, MD Medical School,Southeast University
  More Information

No publications provided

Responsible Party: Li Chen, Zhongda Hospital, Southeast University Nanjing, Jiangsu, China, Southeast University, China
ClinicalTrials.gov Identifier: NCT01563484     History of Changes
Other Study ID Numbers: 320982198703092517
Study First Received: March 20, 2012
Last Updated: March 30, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Southeast University, China:
Primary Hepatocellular Carcinoma(HCC)
Transarterial chemoembolization (TACE)
Liver function
Renal function

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 17, 2014