Clinical trial NCT00825474: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: small hepatocellular carcinoma
partial hepatectomy
TACE plus PEI
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: overall survival
timeFrame: 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital
name: shen feng, MD
role: STUDY_CHAIR
References: