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Trial record 19 of 1425 for:    bilirubin AND alanine

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

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ClinicalTrials.gov Identifier: NCT01563484
Recruitment Status : Unknown
Verified March 2012 by Li Chen, Southeast University, China.
Recruitment status was:  Active, not recruiting
First Posted : March 27, 2012
Last Update Posted : April 2, 2012
Sponsor:
Information provided by (Responsible Party):
Li Chen, Southeast University, China

Tracking Information
First Submitted Date March 20, 2012
First Posted Date March 27, 2012
Last Update Posted Date April 2, 2012
Study Start Date March 2012
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2012)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01563484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Liver and Renal Function After Transarterial Chemoembolization for Primary Hepatocellular Carcinoma With Iso-osmolar Contrast Media and Low Osmolar Contrast Media
Official Title Comparison of Liver and Renal Function After TACE for PHC With Iso-osmolar and Low-osmolar Contrast Media
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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Primary Hepatocellular Carcinoma
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 26, 2012)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2012
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01563484
Other Study ID Numbers 320982198703092517
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Li Chen, Southeast University, China
Study Sponsor Li Chen
Collaborators Not Provided
Investigators
Principal Investigator: Gao-Jun Teng, MD Medical School,Southeast University
PRS Account Southeast University, China
Verification Date March 2012