UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037497 |
|---|---|
| Receipt number | R000042744 |
| Scientific Title | Study of the pancreatic endocrine and exocrine insufficiency after pancreatic resection |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2023/10/02 18:56:14 |
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Basic information
Public title
Study of the pancreatic endocrine and exocrine insufficiency after pancreatic resection
Acronym
Study of the pancreatic endocrine and exocrine insufficiency after pancreatic resection
Scientific Title
Study of the pancreatic endocrine and exocrine insufficiency after pancreatic resection
Scientific Title:Acronym
Study of the pancreatic endocrine and exocrine insufficiency after pancreatic resection
Region
| Japan |
Condition
Condition
Pancreatic endocrine and exocrine insufficiency after pancreatic resection
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the pancreatic endocrine and exocrine insufficiency after pancreatic resection.
Basic objectives2
Others
Basic objectives -Others
To clarify the changes of body density and body composition after pancreatic resection.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of pancreatic endocrine and exocrine insufficiency after pancreatic resection
Key secondary outcomes
The changes of body density and body composition after pancreatic resection
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have received pancreatic resection in the past
Key exclusion criteria
1.Patients who have recurrence of the primary tumor.
2.patients with liver cirrhosis or active hepatitis
3.Patients with chronic renal failure requiring dialysis
4.Patients with other malignant disease
5.Patients who are diagnosed to be ineligible by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Saiura |
Organization
Juntendo University School of Medicine
Division name
Department of Hepatobiliary-Pancreatic Surgery
Zip code
113-8421
Address
2-1-1,hongo,bunnkyouku,tokyo,japan
TEL
03-3813-3111
a-saiura@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Ichida |
Organization
Juntendo University School of Medicine
Division name
Department of Hepatobiliary-Pancreatic Surgery
Zip code
113-8421
Address
2-1-1,hongo,bunnkyouku,tokyo,japan
TEL
03-3813-3111
Homepage URL
hichida@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
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
Juntendo University School of Medicine
Address
2-1-1,hongo,bunnkyouku,tokyo,japan
Tel
03-3813-3111
hichida@juntendo.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
| 2019 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is to clarify the pancreatic endocrine and exocrine insufficiency after pancreatic resection by 1.questionnaire, 2.blood exam test, 3.PFD test, 4.bone mineral quantitative inspection, 5.InBody (body composition).
Management information
Registered date
| 2019 | Year | 07 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042744
| Research Plan | |
|---|---|
| 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 |
