Back to resultsUlinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ulinastatin
Diammonium glycyrrhizinate
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Ulinastatin, Hepatic Failure
Eligibility Criteria
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.
Sites / Locations
- Eastern Hepatobiliary Surgery Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Diammonium glycyrrhizinate
Ulinastatin
Arm Description
Conventional drugs protect liver
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)
Outcomes
Primary Outcome Measures
the overall survival rate of each group
Secondary Outcome Measures
Full Information
NCT ID
NCT01643447
First Posted
July 16, 2012
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01643447
Brief Title
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)
Official Title
A Prospective Randomized Trial Comparing Ulinastatin's Drug Protection in Hepatocellular Carcinoma(HCC)Patients'Postoperative Hepatic Failure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Ulinastatin, Hepatic Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diammonium glycyrrhizinate
Arm Type
Active Comparator
Arm Description
Conventional drugs protect liver
Arm Title
Ulinastatin
Arm Type
Experimental
Arm Description
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)
Intervention Type
Drug
Intervention Name(s)
Ulinastatin
Intervention Description
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)
Intervention Type
Drug
Intervention Name(s)
Diammonium glycyrrhizinate
Primary Outcome Measure Information:
Title
the overall survival rate of each group
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Aijun, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)
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