A Prospective Randomized Trial Comparing Partial Hepatectomy and TACE Plus PEI for Small Hepatocellular Carcinoma
18 Years
70 Years
Both
Hepatocellular Carcinoma
Trial Information
A Prospective Randomized Trial Comparing Partial Hepatectomy and TACE Plus PEI for Small Hepatocellular Carcinoma
randomly put in group standard:
1. via clinical diagnosis and confirm it is primary liver cancer, and not accept any
anticancer treatment.
2. age: 18-70 years.
3. early hepatocyte cancer，which is single focus of infection diameter ≤ 3 cm.
4. estimate tumor can gain treatment of curing operation or TACE plus PEI.
5. 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:
1. ensemble life span.To compare 1、2 and 3 year overall survival rate in hepatectomy and
TACE plus PEI for small hepatocellular carcinoma
2. intraliver recurrence rate; distant metastasis rate; non-tumor life span; band tumor
life span
Telephone call at any time
Inclusion Criteria:
1. via clinical diagnosis and confirm it is primary liver cancer, and not accept any
anticancer treatment.
2. age:18-70years
3. early hepatocyte cancer，which is single focus of infection diameter ≤3cm.
4. estimate tumor can gain treatment of curing operation or micro-create treatment
combineation
5. better liver function (Child-Pugh，class A or B)
Exclusion Criteria:
1. reject to attend；
2. impossible to come to our hospital for physical examination regularly.
3. cancer epitome、seed focus、lymph node or distant metastasis
4. Blood clotting function hindrance;
5. serious heart、lung、kidney disease.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall survival
Outcome Time Frame:
2010
Safety Issue:
No
Principal Investigator
shen feng, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Eastern Hepatobiliary Surgery Hospital
Authority:
China: Ministry of Health
Study ID:
EHBH-RCT-2008-003
NCT ID:
NCT00825474
Start Date:
August 2008
Completion Date:
August 2010
Related Keywords:
- Hepatocellular Carcinoma
- small hepatocellular carcinoma
- partial hepatectomy
- TACE plus PEI
- Carcinoma
- Carcinoma, Hepatocellular
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