UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045514 |
|---|---|
| Receipt number | R000051964 |
| Scientific Title | Influence of Gustatory Changes and Anxiety/Depression on Prolonged Malnutrition after Major HBP Surgery |
| Date of disclosure of the study information | 2021/09/18 |
| Last modified on | 2021/09/18 14:00:40 |
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Basic information
Public title
Influence of Gustatory Changes and Anxiety/Depression on Prolonged Malnutrition after Major HBP Surgery
Acronym
GustAD study
Scientific Title
Influence of Gustatory Changes and Anxiety/Depression on Prolonged Malnutrition after Major HBP Surgery
Scientific Title:Acronym
GustAD study
Region
| Japan |
Condition
Condition
patients who are undergoing maror hepatectomy or pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of perioperative malnutrition using gustatory and anxious assessment questionnaires
Basic objectives2
Others
Basic objectives -Others
Evaluation of perioperative malnutrition using gustatory and anxious assessment questionnaires
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between questionaries outcome and malnutrition
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are undergoing major hepatectomy or pancreaticoduodenectomy
Key exclusion criteria
patients who did not agree with the study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Takamoto |
Organization
National Cancer Center Hospital
Division name
Division of hepatobiliary pancreatic surgery
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
takamoto@nifty.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | Takamoto |
| Last name | Takamoto |
Organization
National Cancer Center Hospital
Division name
Hepatibilliary Pancreatic Surgery
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
takamoto@nifty.com
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
National Cancer Center Hospital
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
takamoto@nifty.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-261
Org. issuing International ID_1
2020-261
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 09 | Month | 18 | Day |
Last modified on
| 2021 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051964
