UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014598
Receipt number R000016984
Scientific Title Study on glucose and amino acid level included in the infusion at the perioperative period of the gastrectomy
Date of disclosure of the study information 2014/07/22
Last modified on 2019/07/30 15:55:38

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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 or person

Institute

Department of Surgery, School of Medicine, Keio University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016984


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name