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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825474
• Other study ID #: EHBH-RCT-2008-003
• Status: Completed
• Phase: N/A
• First received: January 15, 2009
• Last updated: March 30, 2016
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		2010	No