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

NCT01563484 | Unknown DMC

• 1 other identifier: 320982198703092517
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Hepatocellular Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• years;
• PHC that could not be treated with surgery;
• Patients with clear consciousness，Cooperation;
• Informed consent: authorization and signature.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Li Chen: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Gao-Jun Teng, MD

  Medical School,Southeast University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Zhongda Hospital, Southeast University Nanjing, Jiangsu, China

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 27, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 2, 2012

Record last verified: 2012-03

Locations

CN (1)