UMIN-CTR Clinical Trial

Basic information
Public title	Study on glucose and amino acid level included in the infusion at the perioperative period of the gastrectomy
Acronym	Study on glucose and amino acid level included in the infusion at the perioperative period of the gastrectomy
Scientific Title	Study on glucose and amino acid level included in the infusion at the perioperative period of the gastrectomy
Scientific Title:Acronym	Study on glucose and amino acid level included in the infusion at the perioperative period of the gastrectomy
Region	Japan

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

Objectives
Narrative objectives1	A purpose of this study is to clarify the influence that the vein nourishment management with glucose and the amino acid after the gastrectomy gives for patient recovery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	urinary 3-methylhistidine as protein metabolism valuation.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Amino acid free arm (NPC/N ratio = 0)
Interventions/Control_2	Amino acid and glucose arm (NPC/N ratio = about 150)
Interventions/Control_3	Animo acid (NPC/N ratio = about 64)
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	25 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Planned gastrectomy patient 2.The patient that an agreement was provided in a document from the person before registration 3.Weight:45-70kg 4.ASAPS 1or2
Key exclusion criteria	1.Patient with the past of a coronary heart disease, the cerebrovascular disorde 2.Patient with a renal function disorder 3.Patient with the electrolyte abnormality 4.Patient with a Diabetic Miatus 5.Patient receiving the diuretic 6.Patient receiving the steroid 7.The patient who does central veins nourishment 8.Highly obese patient(BMI 35 over) 9.Thin patient(BMI 17.5 under) 10.the pregnant 11.Patient with the remote metastasis 12.The patient who enforces medical treatment in preoperation 13.Patient with weight losses more than 10% of in preoperation within six months 14.Patient considered to be inappropriate as an object of this study by the judgment of the doctor
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hiroya Middle name Last name Takeuchi
Organization	School of Medicine, Keio University
Division name	Department of Surgery
Zip code	160-8582
Address	Tokyo to sinnjuku ku sinanomachi 35
TEL	03-3353-1211
Email	htakeuch@sc.itc.keio.ac.jp

Public contact
Name of contact person	1st name Kazumasa Middle name Last name Fukuda
Organization	School of Medicine, Keio University
Division name	Department of Surgery
Zip code	160-8582
Address	Tokyo to sinnjuku ku sinanomachi 35
TEL	03-3353-1211
Homepage URL
Email	fukudak@z6.keio.jp

Sponsor
Institute	Department of Surgery, School of Medicine, Keio University
Institute
Department

Funding Source
Organization	Department of Surgery, School of Medicine, Keio University
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	Keio University School of Medicine, Ethics Committee
Address	Tokyo to sinnjuku ku sinanomachi 35
Tel	03-5363-3503
Email	med-rinri-jimu@adst.keio.ac.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	2014 Year 07 Month 22 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2011 Year 07 Month 29 Day
Date of IRB	2011 Year 07 Month 29 Day
Anticipated trial start date	2011 Year 10 Month 30 Day
Last follow-up date	2017 Year 03 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 07 Month 20 Day
Last modified on	2019 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016984