Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Diammonium glycyrrhizinate; Drug: Ulinastatin

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Eastern Hepatobiliary Surgery Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the overall survival rate of each group	3 years

Collaborators and Investigators

• Sponsor: Eastern Hepatobiliary Surgery Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (ESTIMATE): July 18, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 30, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Ulinastatin; Hepatic Failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Liver Failure; Hepatic Insufficiency; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Protease Inhibitors; Serine Proteinase Inhibitors; Trypsin Inhibitors; Urinastatin; Glycyrrhizic Acid
• Other Study ID Numbers: EHBH-RCT-2012-001