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Completed

NCT Number: NCT01643447

Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)

The purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that Ulinastatin can improve survival in HCC patients or not.

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Key information

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

About this study

Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad, still shows a rising trend. Postoperative hepatic failure remains a major reason of liver resection's failure.

  • As broad spectrum of enzyme inhibitors, Ulinastatin has the valid therapeutical effect of hepatic failure and hepatic ischemia-reperfusion injury in animal experiment. And it restrain inflammatory mediator to release. But it's lack of clinical evidence that Ulinastatin reduce the incidence of postoperative hepatic failure in HCC patients The purpose of the study is to assess the effort for comparing Ulinastatin's drug protection in patients with hepatocellular carcinoma (HCC) for postoperative hepatic failure and to evaluate that Ulinastatin can improve survival in HCC patients or not.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients > 35 years and <=55 years of age.
  • confirmed case (patients with HCC)
  • Tumors can be radical removed and resection volume was 50% to 70%.
  • Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
  • No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³.
  • Karnofsky Performance Score performance over 60.
  • Patients who can understand this trial and have signed information consent.

Exclusion criteria

  • Patients who have undergone previous treatment by Ulinastatin.
  • Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.
  • Patients with other diseases which may affect the treatment mentioned here.
  • Patients with medical history of other malignant tumors.
  • Subjects participating in other clinical trials.
  • Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.
  • Patients would not sign the consent to the trial.

Treatment and study plan

Ulinastatin

Drug

Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)

Diammonium glycyrrhizinate

Drug

Primary outcomes

  1. the overall survival rate of each group

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study title

A Prospective Randomized Trial Comparing Ulinastatin's Drug Protection in Hepatocellular Carcinoma(HCC)Patients'Postoperative Hepatic Failure

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 18, 2012
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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