UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005530
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Toho University Omori Medical Center
Institute
Department

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
URL(English) https://upload.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


Contact us.