Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)

Sponsor

Eastern Hepatobiliary Surgery Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01643447

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Ulinastatin Drug: Diammonium glycyrrhizinate	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Diammonium glycyrrhizinate Conventional drugs protect liver	Drug: Diammonium glycyrrhizinate
Experimental: Ulinastatin Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)	Drug: Ulinastatin Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)

Arm

Intervention/Treatment

Active Comparator: Diammonium glycyrrhizinate

Conventional drugs protect liver

Drug: Diammonium glycyrrhizinate

Experimental: Ulinastatin

Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)

Drug: Ulinastatin

Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)

Outcome Measures

Primary Outcome Measures

the overall survival rate of each group [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.