UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027113
Receipt No. R000031069
Scientific Title Prospective study of short- and long-term outcomes of anatomic liver resection and local resection for hepatocellular carcinoma
Date of disclosure of the study information 2017/04/24
Last modified on 2017/04/24

* 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 Prospective study of short- and long-term outcomes of anatomic liver resection and local resection for hepatocellular carcinoma
Acronym anatomic liver resection and local resection for hepatocellular carcinoma
Scientific Title Prospective study of short- and long-term outcomes of anatomic liver resection and local resection for hepatocellular carcinoma
Scientific Title:Acronym anatomic liver resection and local resection for hepatocellular carcinoma
Region
Asia(except Japan)

Condition
Condition The patients of HCC.
Classification by specialty
Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 RCT study to compare the anatomic liver resection and local resection in the early and long-term prognosis of HCC, at the same time to compare the detection rate of MVI, and thus to provide the basis for the choice of surgical resection of HCC.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Long-term efficacy of patients after surgery
Key secondary outcomes Surgical safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Anatomic resection for HCC
Interventions/Control_2 Local resection for HCC
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1.All patients were HCC, diagnosis based on contrast-enhanced ultrasound and enhanced CT or MRI combined
2.Cases for the first diagnosis of HCC patients.
3.The lesion is a single nodule with a diameter of 2-5 cm
4.Liver function is Child A level
5.No other serious complications: such as coagulation dysfunction, severe ascites, peritonitis, biliary infection
6.The patient can be followed up continuously and the patient records are complete
Key exclusion criteria 1.Liver benign tumor or metastatic liver cancer
2.Hepatocellular carcinoma with portal vein or cholangiocarcinoma
3.Patients can not be followed up or the patient records are incomplete
4.Combined with major organ failure, such as combined heart function, renal failure, intractable large number of ascites, disturbance of consciousness, apparent cachexia, etc.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Cai Shou-Wang
Organization Chinese PLA General Hospital, Chinese PLA Postgraduate Medical School
Division name Hospital & Institute of Hepatobiliary Surgery
Zip code
Address No.28 Fuxing Road, Haidian District, Beijing, China
TEL 01066938030
Email caisw301@163.com

Public contact
Name of contact person
1st name
Middle name
Last name Chen JI-Ye
Organization Chinese PLA General Hospital, Chinese PLA Postgraduate Medical School
Division name Hospital & Institute of Hepatobiliary Surgery
Zip code
Address No.28 Fuxing Road, Haidian District, Beijing, China
TEL 010-66938032
Homepage URL
Email chensir338@126.com

Sponsor
Institute Chinese PLA General Hospital, Chinese PLA Postgraduate Medical School
Institute
Department

Funding Source
Organization Chinese PLA General Hospital, Chinese PLA Postgraduate Medical School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 Hospital & Institute of Hepatobiliary Surgery,Chinese PLA General Hospital, Chinese PLA Postgraduate Medical School,Beijing, China

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 24 Day

Related information
URL releasing protocol
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 Preinitiation
Date of protocol fixation
2017 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 24 Day
Last modified on
2017 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031069

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.