UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Surgery for colorectal liver metastases in the setting of extrahepatic disease in the era of multidisciplinary approaches
Title of the study (Brief title)	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	Akio Saiura
Organization	Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name	the Department of Gastroenterological Surgery
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	Akio Saiura
Organization	Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name	the Department of Gastroenterological Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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