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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00825474

Enrollment

160

Registered

2009-01-21

Start date

2008-08-31

Completion date

2010-08-31

Last updated

2016-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

small hepatocellular carcinoma, partial hepatectomy, TACE plus PEI

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: 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

Interventions

OTHERoperation;TACE plus PEI

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
overall survival	2010

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026