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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
operation;TACE plus PEI
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring small hepatocellular carcinoma, partial hepatectomy, TACE plus PEI

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Eastern Hepatobiliary Surgery Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

survival rate

Arm Description

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

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Full Information

First Posted
January 15, 2009
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00825474
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: via clinical diagnosis and confirm it is primary liver cancer, and not accept any anticancer treatment. age: 18-70 years. early hepatocyte cancer,which is single focus of infection diameter ≤ 3 cm. estimate tumor can gain treatment of curing operation or TACE plus PEI. 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: ensemble life span.To compare 1、2 and 3 year overall survival rate in hepatectomy and TACE plus PEI for small hepatocellular carcinoma intraliver recurrence rate; distant metastasis rate; non-tumor life span; band tumor life span Telephone call at any time

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
small hepatocellular carcinoma, partial hepatectomy, TACE plus PEI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
survival rate
Arm Type
Experimental
Arm Description
therapeutic effect of partial hepatectomy or TACE plus PEI for small hepatocellular carcinoma
Intervention Type
Other
Intervention Name(s)
operation;TACE plus PEI
Other Intervention Name(s)
surgical resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: via clinical diagnosis and confirm it is primary liver cancer, and not accept any anticancer treatment. age:18-70years early hepatocyte cancer,which is single focus of infection diameter ≤3cm. estimate tumor can gain treatment of curing operation or micro-create treatment combineation better liver function (Child-Pugh,class A or B) Exclusion Criteria: reject to attend; impossible to come to our hospital for physical examination regularly. cancer epitome、seed focus、lymph node or distant metastasis Blood clotting function hindrance; serious heart、lung、kidney disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shen feng, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

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

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