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

NCT ID: NCT00825474

Last Updated: 2016-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-08-31

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

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Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

survival rate

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

Group Type: EXPERIMENTAL

operation;TACE plus PEI

Intervention Type: OTHER

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.

Interventions

operation;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.

Intervention Type: OTHER

Other Intervention Names

surgical resection

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: lead

Responsible Party

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospotal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

shen feng, MD

Role: STUDY_CHAIR

Eastern Hepatobiliary Surgery Hospital

Locations

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

EHBH-RCT-2008-003

Identifier Type: -

Identifier Source: org_study_id