UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029660 |
|---|---|
| Receipt number | R000033890 |
| Scientific Title | Surgery for colorectal liver metastases in the setting of extrahepatic disease in the era of multidisciplinary approaches |
| Date of disclosure of the study information | 2017/10/23 |
| Last modified on | 2017/10/22 22:08:48 |
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Basic information
Public title
Surgery for colorectal liver metastases in the setting of extrahepatic disease in the era of multidisciplinary approaches
Acronym
Surgery for CLM in the setting of EHD
Scientific Title
Surgery for colorectal liver metastases in the setting of extrahepatic disease in the era of multidisciplinary approaches
Scientific Title:Acronym
Surgery for CLM in the setting of EHD
Region
| Japan |
Condition
Condition
Extrahepatic disease from colorectal cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Concomitant extrahepatic disease has been accepted as a poor prognostic factor of surgery for colorectal liver metastases (CLM). However, recent advances in multidisciplinary approach have dramatically changed the treatment strategy and outcomes in patients with CLM. Clinical implication of aggressive surgery for CLM in the setting of extrahepatic disease needs to be reviewed in the modern era because the impact of recent advances in multidisciplinary approaches has not been considered in previous series.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year overall survival of patients with extrahepatic in the recent period (2005-2012 year) compared to the previous period (1999-2004 year)
Key secondary outcomes
Comparison among 5-year overall survival of patients with extra hepatic disease undergoing hepatectomy.
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
We reviewed the prospectively maintained database of 581 patients who underwent initial liver resection for CLM between January 1999 and December 2012. 11 patients who did not undergo curative surgery were excluded from the analysis. Among the remaining 570 patients, 78 patients (13.6%) had concomitant EHD at the time of preoperative investigation or surgery, and EHD was surgically treated during or metachronously after hepatectomy.
Key exclusion criteria
1 patients who did not undergo curative surgery were excluded from the analysis.
Target sample size
581
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Saiura |
Organization
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name
the Department of Gastroenterological Surgery
Zip code
Address
3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL
+81-3-3520-0111
saiura-tky@umin.ac.jp.
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Saiura |
Organization
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name
the Department of Gastroenterological Surgery
Zip code
Address
3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL
+81-3-3520-0111
Homepage URL
saiura-tky@umin.ac.jp.
Sponsor or person
Institute
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
None declared.
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
Address
Tel
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
| 2017 | Year | 10 | Month | 23 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None declared.
Management information
Registered date
| 2017 | Year | 10 | Month | 22 | Day |
Last modified on
| 2017 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033890
