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
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
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
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
