UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001796
Receipt No. R000002166
Scientific Title Efficacy of surgery vs. radiofrequency ablation on primary hepatocellular carcinoma: a prospective cohort study
Date of disclosure of the study information 2009/04/01
Last modified on 2016/09/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of surgery vs. radiofrequency ablation on primary hepatocellular carcinoma: a prospective cohort study
Acronym Surgery vs. RFA for hepatocellular carcinoma: a prospective cohort study (SURF-cohort)
Scientific Title Efficacy of surgery vs. radiofrequency ablation on primary hepatocellular carcinoma: a prospective cohort study
Scientific Title:Acronym Surgery vs. RFA for hepatocellular carcinoma: a prospective cohort study (SURF-cohort)
Region
Japan

Condition
Condition A case without informed consent for SURF-RCT among primary hepatocellular carcinoma cases with tumor foci numbering less than 3, each measuring 3 cm or less, Child-Pugh score of 7 or less, ages between 20 and 79 year, and indications for either surgical resection or radiofrequency ablation for the treatment
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of surgical resection and radiofrequency ablation on primary hepatocellular carcinoma with tumor foci numbering less than 3, each measuring 3 cm or less, and Child-Pugh score of 7 or less.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival
Recurrence-free survival
Key secondary outcomes Types of recurrence
Therapeutic choice for primary recurrence

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1) no preceded treatment
2) tumor foci numbering less than 3 and each measuring 3 cm or less exhibiting typical findings on dynamic CT
3) no extrahepatic lesion or vascular invasion
4) Child-Pugh score of 7 or less
5) tumors which can be curatively treated with both surgery and radiofrequency ablation
6) performance status 0-2
7) bone marrow function and hepatic/renal functions are well maintained
a)White blood cell count: 2000-10000/mm3
b)Platelet count of 50000/mm3 or more
c)Hemoglobin of 8.0g/dL or more
d)Serum total bilirubin of 2.0mg/dL or less
e)Prothronbin time of 50% or more
f)Serum creatinine of 1.5mg/dL or less
g)Blood urea nitrogen of 35mg/dL or less
Key exclusion criteria 1) Double cancer or history of other malignancy within 5 years after diagnosis
2) History of myocardial infarction or unstable angina within 6 months prior to registration
3) Patient with interstitial pneumonia, pneumofibrosis, or severe lung emphysema
4) Patient who cannot undergo enhanced CT scan due to some reason such as allergy for iodized contrast media or renal dysfunction
5) Patient with psychiatric disorder or symptom
6) Pregnant patient or patient with possibility to be pregnant
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Kokudo
Organization Tokyo University Hospital
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411(33321)
Email KOKUDO-2SU@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoshi Hasegawa
Organization Tokyo Univesrsity Hospital
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411(33321)
Homepage URL http://www.surftrial.jp
Email kihase-tky@umin.ac.jp

Sponsor
Institute Surgery vs. RFA (SURF) trial group
Institute
Department

Funding Source
Organization A grant-in-aid for Scientific Research from the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) Japanese Foundation for Multidisciplinary Treatment of Cancer

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 04 Month 01 Day

Related information
URL releasing protocol http://www.surftrial.jp
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2009 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective non-randomized cohort study.
Either liver resection or RFA will be done for hepatocellular carcinoma in an eligible patient. The long-term outcomes will be evaluated.

Management information
Registered date
2009 Year 03 Month 25 Day
Last modified on
2016 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002166

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.