A Prospective Randomized Trial Comparing Partial Hepatectomy and TACE Plus PEI for Small Hepatocellular Carcinoma

Naval Military Medical University (Second Military Medical University)

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Other: operation;TACE plus PEI

Study type: Interventional

Funder types: Other

Identifiers

NCT00825474

EHBH-RCT-2008-003

Details and patient eligibility

About

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.

Full 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

Telephone call at any time

Enrollment: 160 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

survival rate

Experimental group

Description:

therapeutic effect of partial hepatectomy or TACE plus PEI for small hepatocellular carcinoma

Treatment:

Other: operation;TACE plus PEI