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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029660
Receipt No. 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

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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
Email 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
Email saiura-tky@umin.ac.jp.

Sponsor
Institute Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033890

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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