UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052953 |
|---|---|
| Receipt number | R000060419 |
| Scientific Title | Questionnaire survey on functional evaluation before and after hepatobiliary and pancreatic disease treatment for elderly patients |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/11/30 13:50:31 |
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Basic information
Public title
Questionnaire survey on functional evaluation before and after hepatobiliary and pancreatic disease treatment for elderly patients
Acronym
Questionnaire survey before and after hepatobiliary and pancreatic disease treatment for elderly patients
Scientific Title
Questionnaire survey on functional evaluation before and after hepatobiliary and pancreatic disease treatment for elderly patients
Scientific Title:Acronym
Questionnaire survey before and after hepatobiliary and pancreatic disease treatment for elderly patients
Region
| Japan |
Condition
Condition
Hepatobiliary and pancreatic disease for elderly patients
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this questionnaire is to establish a method for assessing function prior to treatment and to identify risk factors for functional decline and the development of short- and long-term complications after treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire scores before and at 1, 3, 6, and 12 months after treatment
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
| 60 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hepatobiliary and pancreatic disease patients over 60 years of age
Key exclusion criteria
Survey nonrespondents are completely excluded from the study population and no medical record information is used.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Ueda |
Organization
Graduate School of Medicine, Tokyo Medical and Dental University.
Division name
Department of Hepatobiliary and Pancreatic Surgery.
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
TEL
0358035928
uedamsrg@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Ueda |
Organization
Graduate School of Medicine, Tokyo Medical and Dental University.
Division name
Department of Hepatobiliary and Pancreatic Surgery.
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan.
TEL
0358035928
Homepage URL
uedamsrg@tmd.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Tokyo Medical and Dental University.
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
Graduate School of Medicine, Tokyo Medical and Dental University.
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan.
Tel
0358035928
uedamsrg@tmd.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
| 2024 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a non-invasive observational study.
Management information
Registered date
| 2023 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060419
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
