UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041288 |
|---|---|
| Receipt number | 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 13:18:28 |
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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
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
ktaura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047142
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
