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

• ClinicalTrials.gov Identifier: NCT01563484
• Recruitment Status: Unknown
• First Posted: March 27, 2012
• Last Update Posted: April 2, 2012
• Sponsor: Li Chen
• 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
• 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

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

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