UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027113 |
|---|---|
| Receipt number | 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 18:47:40 |
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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
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
chensir338@126.com
Sponsor or person
Institute
Chinese PLA General Hospital, Chinese PLA Postgraduate Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031069
