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
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Condition or disease |
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Primary Hepatocellular Carcinoma |
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 |
Estimated Enrollment : | 50 participants |
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 |
Study Start Date : | March 2012 |
Estimated Primary Completion Date : | September 2012 |
Estimated Study Completion Date : | September 2012 |

Group/Cohort |
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low-osmolar contrast media
Patients undergo TACE of low-osmolar contrast media on day 1.
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iso-osmolar contrast media
Patients undergo TACE of iso-osmolar contrast media on day 1.
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- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563484
China, Jiangsu | |
Zhongda Hospital, Southeast University | |
Nanjing, Jiangsu, China, 210009 |
Principal Investigator: | Gao-Jun Teng, MD | Medical School,Southeast University |
Responsible Party: | Li Chen, Zhongda Hospital, Southeast University Nanjing, Jiangsu, China, Southeast University, China |
ClinicalTrials.gov Identifier: | NCT01563484 |
Other Study ID Numbers: |
320982198703092517 |
First Posted: | March 27, 2012 Key Record Dates |
Last Update Posted: | April 2, 2012 |
Last Verified: | March 2012 |
Primary Hepatocellular Carcinoma(HCC) Transarterial chemoembolization (TACE) Liver function Renal function |
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 |