A Prospective Randomized Trial Comparing Partial Hepatectomy and TACE Plus PEI for Small Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
operation;TACE plus PEI
Sponsored by

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring small hepatocellular carcinoma, partial hepatectomy, TACE plus PEI
Eligibility Criteria
Inclusion Criteria:
- via clinical diagnosis and confirm it is primary liver cancer, and not accept any anticancer treatment.
- age:18-70years
- early hepatocyte cancer,which is single focus of infection diameter ≤3cm.
- estimate tumor can gain treatment of curing operation or micro-create treatment combineation
- better liver function (Child-Pugh,class A or B)
Exclusion Criteria:
- reject to attend;
- impossible to come to our hospital for physical examination regularly.
- cancer epitome、seed focus、lymph node or distant metastasis
- Blood clotting function hindrance;
- serious heart、lung、kidney disease.
Sites / Locations
- Eastern Hepatobiliary Surgery Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
survival rate
Arm Description
therapeutic effect of partial hepatectomy or TACE plus PEI for small hepatocellular carcinoma
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00825474
First Posted
January 15, 2009
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00825474
Brief Title
A Prospective Randomized Trial Comparing Partial Hepatectomy and TACE Plus PEI for Small Hepatocellular Carcinoma
Official Title
A Prospective Randomized Trial Comparing Partial Hepatectomy and TACE Plus PEI for Small Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2010 (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
Presently,the diagnostic method of small hepatocellular carcinoma has been greatly elevated in China.The treatment is being from simplification to diversification,from entirety to individualization.Confronting small hepatocellular carcinoma,we not select simple operation treatment but select a treatment that have more predominance and more fitting with patients in various kinds of treatment methods;including operation ,TACE,PEI,et al.which is better ? There are many arguments.
Detailed Description
randomly put in group standard:
via clinical diagnosis and confirm it is primary liver cancer, and not accept any anticancer treatment.
age: 18-70 years.
early hepatocyte cancer,which is single focus of infection diameter ≤ 3 cm.
estimate tumor can gain treatment of curing operation or TACE plus PEI.
better liver function (Child-Pugh,class A or B).
Case loads: 160 residents with small hepatocellular carcinoma in China
Therapeutic regimen: under normal rules, the operation group open abdomen to perform operation through subtotal incision while the patient has been general anesthesia with trachea cannula. The operation range on hepatic tissue of un-tumor tissue around tumor should maintain at least 1cm. As for the micro-create treatment combination group, taking TACE all through arteria cruralies super-elect arteria hepatica and injecting MITO、FUDR、iodipin. By B transonogram guiding to nyxis liver biopsy,and perform per cutem absolute alcohol injection treatment.
Research end-point:
ensemble life span.To compare 1、2 and 3 year overall survival rate in hepatectomy and TACE plus PEI for small hepatocellular carcinoma
intraliver recurrence rate; distant metastasis rate; non-tumor life span; band tumor life span
Telephone call at any time
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
small hepatocellular carcinoma, partial hepatectomy, TACE plus PEI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
survival rate
Arm Type
Experimental
Arm Description
therapeutic effect of partial hepatectomy or TACE plus PEI for small hepatocellular carcinoma
Intervention Type
Other
Intervention Name(s)
operation;TACE plus PEI
Other Intervention Name(s)
surgical resection
Intervention Description
Under normal rules, the operation group open abdomen to perform operation through subtotal incision while the patient has been general anesthesia with trachea cannula. The operation range on hepatic tissue of un-tumor tissue around tumor should maintain at least 1cm. As for the micro-create treatment combination group, taking TACE all through arteria cruralies super-elect arteria hepatica and injecting MITO、FUDR、iodipin. By B transonogram guiding to nyxis liver biopsy,and perform per cutem absolute alcohol injection treatment.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
via clinical diagnosis and confirm it is primary liver cancer, and not accept any anticancer treatment.
age:18-70years
early hepatocyte cancer,which is single focus of infection diameter ≤3cm.
estimate tumor can gain treatment of curing operation or micro-create treatment combineation
better liver function (Child-Pugh,class A or B)
Exclusion Criteria:
reject to attend;
impossible to come to our hospital for physical examination regularly.
cancer epitome、seed focus、lymph node or distant metastasis
Blood clotting function hindrance;
serious heart、lung、kidney disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shen feng, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
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
A Prospective Randomized Trial Comparing Partial Hepatectomy and TACE Plus PEI for Small Hepatocellular Carcinoma
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