UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018763 |
|---|---|
| Receipt number | R000021709 |
| Scientific Title | Prospective multicenter observational study for patients who underwent total pancreatectomy |
| Date of disclosure of the study information | 2015/08/22 |
| Last modified on | 2015/08/22 15:22:18 |
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Basic information
Public title
Prospective multicenter observational study for patients who underwent total pancreatectomy
Acronym
Prospective observational study for total pancreatectomy
Scientific Title
Prospective multicenter observational study for patients who underwent total pancreatectomy
Scientific Title:Acronym
Prospective observational study for total pancreatectomy
Region
| Japan |
Condition
Condition
patients with planned total pancreatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate QOL of the patients, glucose control, frequency of fatty liver after total pancreatectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of QOL one year after total pancreatectomy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with planned total pancreatectomy
Key exclusion criteria
double cancer
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Takeyama |
Organization
Kinki University Faculty of medicine
Division name
department of surgery
Zip code
Address
377-2 ohnohigashi osakasayama city OSAKA
TEL
072-366-0221
takeyama@surg.med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Kamei |
Organization
Kinki University Faculty of medicine
Division name
department of surgery
Zip code
Address
377-2 ohnohigashi osakasayama city OSAKA
TEL
072-366-0221
Homepage URL
keiko-kamei@surg.med.kindai.ac.jp
Sponsor or person
Institute
Kinki University Faculty 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
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
| 2015 | Year | 08 | Month | 22 | 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
| 2015 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate QOL of the patients, glucose control, frequency of fatty liver on labo data and CT after total pancreatectomy
Management information
Registered date
| 2015 | Year | 08 | Month | 22 | Day |
Last modified on
| 2015 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021709
