UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037081 |
|---|---|
| Receipt number | R000042252 |
| Scientific Title | Various Size Distribution of Multiple Colorectal Liver Metastases is a Risk Factor for Remnant Liver Recurrence after Liver Resection |
| Date of disclosure of the study information | 2019/06/16 |
| Last modified on | 2019/06/16 11:56:04 |
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Basic information
Public title
Various Size Distribution of Multiple Colorectal Liver Metastases
is a Risk Factor for Remnant Liver Recurrence after Liver Resection
Acronym
Various Size Distribution of Multiple Colorectal Liver Metastases
is a Risk Factor for Remnant Liver Recurrence after Liver Resection
Scientific Title
Various Size Distribution of Multiple Colorectal Liver Metastases
is a Risk Factor for Remnant Liver Recurrence after Liver Resection
Scientific Title:Acronym
Various Size Distribution of Multiple Colorectal Liver Metastases
is a Risk Factor for Remnant Liver Recurrence after Liver Resection
Region
| Japan |
Condition
Condition
Multiple Colorectal Liver Metastases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to compare the long-term outcomes and recurrence patterns after liver resection in patients with VSD versus No-VSD of MCLM
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
remnant liver recurrence
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
303 consecutive patients treated by curative liver resection for CLM between January 2000 and December 2016
Key exclusion criteria
Repeated liver resection, single CLM, preoperative chemotherapy, and large metastases of 50 mm or more
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Fukami |
Organization
Ogaki Municipal Hospital
Division name
Surgery
Zip code
503-8502
Address
4-86 Minaminokawa-cho, Ogaki, Gifu 503-8502, Japan
TEL
0584-81-3341
yasuyuki490225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Fukami |
Organization
Ogaki Municipal Hospital
Division name
Surgery
Zip code
503-8502
Address
4-86 Minaminokawa-cho, Ogaki, Gifu 503-8502, Japan
TEL
0584-81-3341
Homepage URL
yasuyuki490225@yahoo.co.jp
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Ogaki Municipal Hospital
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
Ogaki Municipal Hospital
Address
4-86 Minaminokawa-cho, Ogaki, Gifu 503-8502, Japan
Tel
0584-81-3341
yasuyuki490225@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 | 06 | Month | 16 | 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
80
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 | 12 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Between January 2000 and December 2016, 303 consecutive patients with CLM underwent liver resection at our institution, defined as the complete removal of tumors detected by preoperative imaging or intraoperative inspection using ultrasonography. After review by a multidisciplinary board, all MCLM were assessed for resectability by hepatobiliary surgeons. Cases of repeat liver resection, a single CLM, and those given preoperative chemotherapy were excluded from the present study. Furthermore, large metastases of 50 mm or more were also excluded because large metastases of > 50 mm are independently associated with overall survival after surgery. All patients provided signed informed consent before undergoing therapy. This study was approved by the Institutional Review Board of our institution (No. 20181277-8). Clinicopathological prognostic factors for survival were analyzed using a prospectively maintained database.
Management information
Registered date
| 2019 | Year | 06 | Month | 16 | Day |
Last modified on
| 2019 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042252
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
