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Trial registered on ANZCTR


Registration number
ACTRN12611000770965
Ethics application status
Approved
Date submitted
25/05/2011
Date registered
22/07/2011
Date last updated
16/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized clinical trial of operation and non-operation for small liver cancer
Scientific title
A randomized clinical trial to compare overall survival and disease-free survival in small liver cancer patients treated with surgery versus transcatheter arterial chemoembolization plus radiofrequency ablation
Secondary ID [1] 1571 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
treatment for small liver cancer 257089 0
Condition category
Condition code
Cancer 257243 257243 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Liver resection was carried out under general anesthesia through a right subcostal incision. The surgery was performed to resect the tumor with a resection margin of at least 1 cm to tumor margin. Pringle’s maneuver was routinely used with a clamp/unclamp time of 15 minutes/5 minutes.
Intervention code [1] 256257 0
Treatment: Surgery
Intervention code [2] 267024 0
Treatment: Other
Comparator / control treatment
Transcatheter arterial chemoembolization plus percutaneous radiofrequency ablative therapy: In this non-operation group,we give the patient transcatheter arterial chemoembolization treatment(injecting lipiodol 5-10 ml, amycin 40 mg, fluorouracil 1000 mg through femoral artery) first, then one week later we give radiofrequence ablation treatment guided by ultrasound.he whole procedure of percutaneous radiofrequency ablative therapy was as follows: Firstly the patient received general anesthesia and then check the location of tumor with ultrasound. The electrode was inserted into the tumor under the ultrasound guidance. Then the system was switched to the impedance mode. The output power was increased from 80W to 200W, lasted 3-10 minutes depending on the size and location of tumors. The patient received enhanced spiral CT or MRI in the second day and one month after RFA to evaluate the effect of RFA. If there was any tumor remaining active, RFA should be repeated until the tumor was complete necrosis.
Control group
Active

Outcomes
Primary outcome [1] 258148 0
the prognosis of small liver cancer treated by operation and non-operation defined by overall survival(OS) and disease free survival(DFS)
Timepoint [1] 258148 0
AFP,Ultrasound monthly and MRI or CT half a year for first 2 years post-surgery, then AFP,Ultrasound every 2 months and MRI or CT half a year up to 5 years post-surgery
Secondary outcome [1] 263786 0
Rate of loco-regional and systemic recurrence on operation and non-operational treatment.
Timepoint [1] 263786 0
AFP,Ultrasound monthly and MRI or CT half a year for first 2 years post-surgery, then AFP,Ultrasound every 2 months and MRI or CT half a year up to 5 years post-surgery

Eligibility
Key inclusion criteria
1.clinically diagnose as primary liver cancer
2.no anticancer treatment
3.single tumor with diametre<=5cm,or multiple focus with diametre<=3cm and number<=3
4.the tumor can be cured by surgery or non-operational treatment(TACE+RFA,OR TACE+PEIT)
5.liver function is Child A or B
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.blood vessel or adjacent organs invasion
2.lymphatic or systemic metastasis
3.coagulation dysfunction

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We collect the proper patients who accord with the key inclusin criteria and then patients are allocated to each group according to the sequence generated by computer. This allocation is leaded by a resercher who is not involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence is generated by computer randomly.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2566 0
China
State/province [1] 2566 0
Shanghai City

Funding & Sponsors
Funding source category [1] 256844 0
Self funded/Unfunded
Name [1] 256844 0
Eastern hepatobiliary hospital
Address [1] 256844 0
Num. 225, Changhai Road, Yangpu District, Shanghai City, China?post code:200438
Country [1] 256844 0
China
Primary sponsor type
Hospital
Name
Eastern hepatobiliary hospital
Address
Num. 225, Changhai Road, Yangpu District, Shanghai City, China, post code:200438
Country
China
Secondary sponsor category [1] 256040 0
University
Name [1] 256040 0
Second military medical university
Address [1] 256040 0
NO. 800, Xiangyin Road, Yangpu District, Shanghai City, China, post code:200433
Country [1] 256040 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258774 0
ethics committee of eastern hepatobiliary surgical hospital
Ethics committee address [1] 258774 0
Ethics committee country [1] 258774 0
China
Date submitted for ethics approval [1] 258774 0
05/01/2006
Approval date [1] 258774 0
25/04/2006
Ethics approval number [1] 258774 0
ZD2006002-P2

Summary
Brief summary
The purpose of our study is to compare the preferences of transcatheter arterial chemoembolization (TACE) plus percutaneous radiofrequency ablative therapy (RFA) and liver resection in the treatment of early small HCC. We suppose that TACE plus RFA can have equal or better effect.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31014 0
Address 31014 0
Country 31014 0
Phone 31014 0
Fax 31014 0
Email 31014 0
Contact person for public queries
Name 14261 0
Weiping Zhou
Address 14261 0
NO.225, Changhai Road, Yangpu District, Shanghai City, China, post code:200438
Country 14261 0
China
Phone 14261 0
0086-021-81875521
Fax 14261 0
Email 14261 0
ehphwp@126.com
Contact person for scientific queries
Name 5189 0
Hui Liu
Address 5189 0
NO.225, Changhai Road, Yangpu District, Shanghai City, China, post code:200438
Country 5189 0
China
Phone 5189 0
0086-021-81875523
Fax 5189 0
Email 5189 0
liuhuigg@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary