UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of short- and long-term outcomes of anatomic liver resection and local resection for hepatocellular carcinoma
Title of the study (Brief title)	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	Cai Shou-Wang
Organization	Chinese PLA General Hospital, Chinese PLA Postgraduate Medical School
Division name	Hospital & Institute of Hepatobiliary Surgery
Address	No.28 Fuxing Road, Haidian District, Beijing, China
TEL	01066938030
Email	caisw301@163.com

Public contact
Name of contact person	Chen JI-Ye
Organization	Chinese PLA General Hospital, Chinese PLA Postgraduate Medical School
Division name	Hospital & Institute of Hepatobiliary Surgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 04 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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