UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053401 |
|---|---|
| Receipt number | R000060945 |
| Scientific Title | Evaluation of two-stage hepatectomy using portal vein embolization for colorectal liver metastasis: a retrospective nationwide cohort survey in Japan |
| Date of disclosure of the study information | 2024/01/21 |
| Last modified on | 2024/01/21 00:24:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of two-stage hepatectomy using portal vein embolization for colorectal liver metastasis: a retrospective nationwide cohort survey in Japan
Acronym
Two-stage hepatectomy for colorectal liver metastasis: a nationwide survey
Scientific Title
Evaluation of two-stage hepatectomy using portal vein embolization for colorectal liver metastasis: a retrospective nationwide cohort survey in Japan
Scientific Title:Acronym
Two-stage hepatectomy for colorectal liver metastasis: a nationwide survey
Region
| Japan |
Condition
Condition
Colorectal liver metastasis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this retrospective study was to evaluate the outcome of two-stage hepatectomy in Japanese patients with CRLM.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Survival
Key secondary outcomes
Progression-free Survival
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent two-stage hepatectomy using portal vein embolization for colorectal liver metastasis
Key exclusion criteria
Patient who did not undergo TSH and Patients who underwent hepatectomy twice for CRLM diagnosed at different times
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Aoki |
Organization
Dokkyo Medical University
Division name
Department of Hepato-Biliary-Pancreatic Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi, Japan
TEL
0282-87-2158
aoki-2su@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Shimizu |
Organization
Dokkyo Medical University
Division name
Department of Hepato-Biliary-Pancreatic Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi,, Japan
TEL
0282-87-2158
Homepage URL
stratstrat1213@yahoo.co.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Dokkyo Medical University Bioethics Committee
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi, Japan
Tel
0282-87-2474
sh-saito@dokkyomed.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
| 2024 | Year | 01 | Month | 21 | 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
53
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conduct a retrospective cohort study using the nationwide database of patients with colorectal liver metastasis. Of this entire cohort, we idetify patients undergoing two-stage hepatectomy. The primary outcome is overall survival. The second outcome measure is progression-free survival.
Management information
Registered date
| 2024 | Year | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060945
