UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037932 |
|---|---|
| Receipt number | R000043238 |
| Scientific Title | Oncological outcomes of repeat metastasectomy for recurrence after hepatectomy for colorectal liver metastases. |
| Date of disclosure of the study information | 2019/09/04 |
| Last modified on | 2020/05/07 13:57:55 |
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Basic information
Public title
Oncological outcomes of repeat metastasectomy for recurrence after hepatectomy for colorectal liver metastases.
Acronym
Repeat metastasectomy for colorectal metastases.
Scientific Title
Oncological outcomes of repeat metastasectomy for recurrence after hepatectomy for colorectal liver metastases.
Scientific Title:Acronym
Repeat metastasectomy for colorectal metastases.
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Surgery in general |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the oncological outcomes of repeat metastasectomy for recurrence to various organs after hepatectomy for colorectal liver metastases and to determine the prognostic factors after repeat surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oncological outcomes of repeat metastasectomy for recurrence to various organs after hepatectomy for colorectal liver metastases.
Key secondary outcomes
To determine the prognostic factors after repeat 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
| 21 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Recurrence after hepatectomy for colorectal liver metastases.
Key exclusion criteria
R0 resection is not possible.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Maeda |
Organization
Hokkaido Cancer Center
Division name
Dept. of Surgery
Zip code
003-0804
Address
4-2-3-54 Kikusui, Shiroishi, Sapporo, 003-0804 JAPAN
TEL
011-811-9111
maeda19671101@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Maeda |
Organization
Hokkaido Cancer Center
Division name
Det. of Curgery
Zip code
003-0804
Address
4-2-3-54 Kikusui, Shiroishi, Sapporo, 003-0804 JAPAN
TEL
0118119111
Homepage URL
maeda19671101@yahoo.co.jp
Sponsor or person
Institute
Hokkaido Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Cencer Center
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido Cancer Center
Address
4-2-3-54 Kikusui, Shiroishi, Sapporo, 003-0804 JAPAN
Tel
0118119111
maeda19671101@yahoo.co.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
| 2019 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
130
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
| 2019 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 09 | Month | 04 | Day |
Last modified on
| 2020 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043238
