UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046357 |
|---|---|
| Receipt number | R000052893 |
| Scientific Title | Survival impact of anatomical and nonanatomical liver resection for colorectal liver metastases patients: a prospective multicenter cohort study |
| Date of disclosure of the study information | 2021/12/12 |
| Last modified on | 2023/06/18 21:22:37 |
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Basic information
Public title
Survival impact of anatomical and nonanatomical liver resection for colorectal liver metastases patients: a prospective multicenter cohort study
Acronym
SAMURAI-Liver Study
Scientific Title
Survival impact of anatomical and nonanatomical liver resection for colorectal liver metastases patients: a prospective multicenter cohort study
Scientific Title:Acronym
SAMURAI-Liver Study
Region
| Japan |
Condition
Condition
Colorectal liver metastases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of the present study is to investigate the relationships between type of liver resection and postoperative survival in colorectal liver metastases patients stratified by the mutational status of RAS and BRAF gene.
Basic objectives2
Others
Basic objectives -Others
Recurrence free and overall survival after the liver resection are evaluated according to the mutational status of RAS and BRAF gene.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence free survival
Key secondary outcomes
Intrahepatic recurrence free survival, extrahepatic recurrence free survival, overall survival, and short term outcome of liver resection.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a) Patients with histologically confirmed colorectal cancer.
b) Patients who are examined the mutational status of RAS and BRAF gene.
c) Patients who have resectable liver metastases and are scheduled for primary liver resection.
d) Patients who are scheduled for anatomical or nonanatomical liver resection.
e) Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
f) Patients who are expected to survive more than 3 months.
g) Patients in whom documented agreement was obtained.
Key exclusion criteria
a) Patients with unresectable primary colorectal cancer or extrahepatic metastases.
b) Patients who are performed second and subsequent liver resection.
c) Patients who are performed anatomical resection with concomitant nonanatomical resection.
d) Patients who are required to perform combination of radiofrequency ablation.
e) Patients in whom a doctor judges inappropriate for this study population.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takamichi |
| Middle name | |
| Last name | Ishii |
Organization
Kyoto University Hospital
Division name
Surgery
Zip code
606-8507
Address
54, Sakyo-ku, Shogoin, Kawahara-cho, Kyoto, Japan
TEL
0757513242
taishii@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kawai |
Organization
Medical Research Institute, Kitano Hospital
Division name
Secretariat of SAMURAI-Liver Study
Zip code
530-8480
Address
2-4-20, Ohgimachi, Kita-ku,Osaka, JAPAN
TEL
06-6312-1221
Homepage URL
u12323@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 606-8501, JAPAN
Tel
075-753-4680
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
大阪赤十字病院（大阪府）
大津赤十字病院（滋賀県）
京都医療センター（京都府）
京都桂病院（京都府）
京都大学医学部附属病院（京都府）
倉敷中央病院（岡山県）
神戸市立医療センター中央市民病院（兵庫県）
滋賀県立成人病センター（滋賀県）
小倉記念病院（福岡県）
神鋼記念病院（兵庫県）
田附興風会北野病院（大阪府）
天理よろづ相談所病院（奈良県）
日本赤十字社和歌山医療センター（和歌山県）
兵庫県立尼崎医療センター（兵庫県）
神戸市立西神戸医療センター（兵庫県）
新東京病院（千葉県）
福井赤十字病院（福井県）
公立豊岡病院（兵庫県）
京都市立病院（京都府）
福岡大学病院（福岡県）
静岡市立静岡病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2021 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052893
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| Registered date | File name |
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