A Prospective Randomized Trial Comparing Partial Hepatectomy and TACE Plus PEI for Small Hepatocellular Carcinoma
Conditions
Hepatocellular Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Hepatocellular
Conditions: Keywords
small hepatocellular carcinoma, partial hepatectomy, TACE plus PEI
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: operation;TACE plus PEI
Type: Other
Overall Status
Recruiting
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:

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

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Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai, China
Status: Recruiting
Contact: zhou weiping, MD - weiping.zhou@hotmail.com
Start Date
August 2008
Completion Date
August 2010
Sponsors
Eastern Hepatobiliary Surgery Hospital
Source
Eastern Hepatobiliary Surgery Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page