UMIN-CTR Clinical Trial

Basic information
Public title	Availability of nutritional evaluation using CT and time-dependent changes of nutritional status in patients treated with gastrectomy
Acronym	Availability of nutritional evaluation using CT and time-dependent changes of nutritional status in patients treated with gastrectomy
Scientific Title	Availability of nutritional evaluation using CT and time-dependent changes of nutritional status in patients treated with gastrectomy
Scientific Title:Acronym	Availability of nutritional evaluation using CT and time-dependent changes of nutritional status in patients treated with gastrectomy
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study is intended for patients with gastrectomy. We investigate the availability in nutritional evaluation of skeletal muscle, subcutaneous adipose tissue, and visceral adipose tissue area using the CT. We analyze the time-dependent changes in nutritional status of each surgical procedures for gastric cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skeletal muscle, subcutaneous adipose tissue, and visceral adipose tissue area using the CT.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who diagnosed as having gastric cancer and intended to undergo gastrectomy. Patients who signed informed consent to participate in the study.
Key exclusion criteria	Patients who cannot get the CT exam. Patients who cannot undergo one-stage gastrectomy. Additionally, patients who are regarded as unsuitable for this study by the investigators.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Okada Genya
Organization	Prefectural University of Hiroshima
Division name	Department of Health Science
Zip code
Address	1-1-71 Ujina-Higashi, Minami-ku, Hiroshima
TEL	+81-8-2251-9841
Email	g-okada@pu-hiroshima.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Okada Genya
Organization	Prefectural University of Hiroshima
Division name	Department of Health Science
Zip code
Address	1-1-71 Ujina-Higashi, Minami-ku, Hiroshima
TEL	+81-8-2251-9841
Homepage URL
Email	g-okada@pu-hiroshima.ac.jp

Sponsor
Institute	Prefectural University of Hiroshima
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Fukuyama city Hospital
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	福山市民病院（広島県）/Fukuyama city Hospital(Hiroshima)

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 25 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 09 Month 29 Day
Date of IRB	2016 Year 09 Month 29 Day
Anticipated trial start date	2017 Year 01 Month 25 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	This study is intended for patients with gastrectomy. We investigate the availability in nutritional evaluation of skeletal muscle, subcutaneous adipose tissue, and visceral adipose tissue area using the CT. We analyze the time-dependent changes in nutritional status of each surgical procedures for gastric cancer.

Management information
Registered date	2017 Year 01 Month 24 Day
Last modified on	2020 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029697