Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643447
• Other study ID #: EHBH-RCT-2012-001
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: March 30, 2016
• Start date: May 2012
• Est. completion date: April 2015

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Male or female patients > 35 years and <=55 years of age.

2. confirmed case (patients with HCC)

3. Tumors can be radical removed and resection volume was 50% to 70%.

4. 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.

5. 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.

6. Karnofsky Performance Score performance over 60.

7. Patients who can understand this trial and have signed information consent.

Exclusion Criteria:

1. Patients who have undergone previous treatment by Ulinastatin.

2. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.

3. Patients with other diseases which may affect the treatment mentioned here.

4. Patients with medical history of other malignant tumors.

5. Subjects participating in other clinical trials.

6. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.

7. Patients would not sign the consent to the trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Failure

Intervention

Drug:
• Ulinastatin
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)
• Diammonium glycyrrhizinate

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the overall survival rate of each group		3 years	No