UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008122 |
|---|---|
| Receipt number | R000009558 |
| Scientific Title | Prospective study on the effect of pancreatectomy in postoperative pancreatic endocrine function |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2018/12/12 18:27:00 |
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Basic information
Public title
Prospective study on the effect of pancreatectomy in postoperative pancreatic endocrine function
Acronym
Prospective study of postoperative pancreatic endocrine function
Scientific Title
Prospective study on the effect of pancreatectomy in postoperative pancreatic endocrine function
Scientific Title:Acronym
Prospective study of postoperative pancreatic endocrine function
Region
| Japan |
Condition
Condition
Pancreatic diseases requiring pancreatectomy
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify the risk factors for endocrine insufficiency following pancreatectomy with the evaluation of details of changes in endocrine and exocrine function and nutritional states.
Basic objectives2
Others
Basic objectives -Others
epidemiology
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
New-onset diabetes in preoperatively non-diabetic patients and the progression of diabetes in preoperatively diabetic patients within 12 months after surgery
Key secondary outcomes
Oral glucose tolerance tests in before and 1, 3, and 12 months after surgery
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with pancreatic disease requiring pancreatectomy
2. Performance status (ECOG Eastern Cooperative Oncology Group) 0-1
3. Age is 18 years old or older
4. No metabolic or endocrine disease except type 2 diabetes
5. No advanced malignant disease except pancreatic disease
6. With one's own consent for this study
Key exclusion criteria
Patients whom the principal investigator judges as not eligible
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirochika Toyama |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6302
toyama@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirochika Toyama |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6302
Homepage URL
toyama@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
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
神戸大学医学部付属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2012 | 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
| 2012 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 01 | Day |
Other
Other related information
Following data are obtained in before and after surgery: oral glucose tolerance test, serum HbA1c, serum albumin, and body weight.
Management information
Registered date
| 2012 | Year | 06 | Month | 07 | Day |
Last modified on
| 2018 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009558
