UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005530
Receipt number R000005900
Scientific Title The Anthropometry with Bioelectrical Inpedance Analysis(BIA) and Dual Energy X-Ray Absoptiometry(DEXA)in perioperative management for gastric and esophageal cancer patients
Date of disclosure of the study information 2011/05/01
Last modified on 2014/12/20 10:05:53

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Basic information

Public title

The Anthropometry with Bioelectrical Inpedance Analysis(BIA) and Dual Energy X-Ray Absoptiometry(DEXA)in perioperative management for gastric and esophageal cancer patients

Acronym

Anthropometry with BIA and DEXA in perioperative management

Scientific Title

The Anthropometry with Bioelectrical Inpedance Analysis(BIA) and Dual Energy X-Ray Absoptiometry(DEXA)in perioperative management for gastric and esophageal cancer patients

Scientific Title:Acronym

Anthropometry with BIA and DEXA in perioperative management

Region

Japan


Condition

Condition

perioperative cases of gastric and esophageal cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To make methods of estimate the lean body mass as perioperative nutritional state.

Basic objectives2

Others

Basic objectives -Others

To investigate which part of body compornent change with the change of body weight.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the perioperative change of data by bioelectorical impedance analysis, dual energy X-Ray absoptiometry

Key secondary outcomes

the differencistes of data in bioelectorical impedance analysis, dual energy X-Ray absoptiometry in each gastrointestinal reconstruction.


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

the over twenty years old patients of gastric and esophageal cancer who will be planed to undergo the operation with their adequate recognition.

Key exclusion criteria

(1)the patient who is consciousless,not understnd the explanation, and is not able to make a appropriate judgement.
(2)The patients who are unmeasurable their height or weight.
(3)The patients who are dicided against suitablity for this study by the reseacher in charge.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Washizawa Naohiro

Organization

Toho University Omori Medical Center

Division name

Nutirion Therapy Center

Zip code


Address

6-11-1, Omori-nishi Ota-ku, Tokyo, Japan

TEL

03-3762-4151

Email

washi@med.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Washizawa Naohiro

Organization

Toho University Omori Medical Center

Division name

Nutirion Therapy Center

Zip code


Address

6-11-1, Omori-nishi, Ota-ku, Tokyo, Japan

TEL

03-3762-4151

Homepage URL


Email

washi@med.toho-u.ac.jp


Sponsor or person

Institute

Toho University Omori Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2011 Year 05 Month 01 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

Enrolling by invitation

Date of protocol fixation

2010 Year 02 Month 08 Day

Date of IRB


Anticipated trial start date

2011 Year 04 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

a


Management information

Registered date

2011 Year 04 Month 29 Day

Last modified on

2014 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005900


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name