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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041288
Receipt No. R000047142
Scientific Title Study on the usefulness of laparoscopic liver resection for hepatocellular carcinoma
Date of disclosure of the study information 2020/08/03
Last modified on 2020/08/03

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Basic information
Public title Study on the usefulness of laparoscopic liver resection for hepatocellular carcinoma
Acronym Study on the usefulness of laparoscopic liver resection for hepatocellular carcinoma
Scientific Title Study on the usefulness of laparoscopic liver resection for hepatocellular carcinoma
Scientific Title:Acronym Study on the usefulness of laparoscopic liver resection for hepatocellular carcinoma
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the usefulness of laparoscopic liver resection by comparing the perioperative outcomes of laparoscopic and open liver resection for hepatectomy in hepatocellular carcinoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of posthepatectomy liver failure
Key secondary outcomes Postoperative blood tests on 1, 2, 3, 5, and 7 days after hepatectomy. Platelet counts, international normalized ratio of prothrombin time, total bilirubin, and alanine aminotransferase.
operation time, blood loss, perioperative complication rate, perioperative mortality, length of hospital stay after surgery

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

Not applicable
Gender Male and Female
Key inclusion criteria A case of liver resection for hepatocellular carcinoma in kyoto university hospital from January 2011 to December 2019
Key exclusion criteria Patients who did not consent to this study
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Kojiro
Middle name
Last name Taura
Organization Graduate School of Medicine, Kyoto University
Division name Hepato Biliary Pancreatic Surgery and Transplantation
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3242
Email ktaura@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Kojiro
Middle name
Last name Taura
Organization Graduate School of Medicine, Kyoto University
Division name Hepato Biliary Pancreatic Surgery and Transplantation
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3242
Homepage URL
Email ktaura@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel 0757534680
Email ethcom@kuhp.kyoto-u.ac.jp

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
2020 Year 08 Month 03 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 344
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 Completed
Date of protocol fixation
2018 Year 05 Month 14 Day
Date of IRB
2018 Year 06 Month 20 Day
Anticipated trial start date
2018 Year 06 Month 20 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 06 Month 19 Day

Other
Other related information Retrospective cohort study
All patients who underwent surgery for hepatocellular carcinoma at Kyoto University Hospital from January 2011 to December 2019 and met the selection criteria

Management information
Registered date
2020 Year 08 Month 03 Day
Last modified on
2020 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047142

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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