UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004644 |
|---|---|
| Receipt number | R000005138 |
| Scientific Title | An observation study of pancreatic endocrine secretion after glucagon infusion on the patients that were operated with a subtotal pancreatectomy |
| Date of disclosure of the study information | 2010/12/02 |
| Last modified on | 2019/07/09 12:49:19 |
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Basic information
Public title
An observation study of pancreatic endocrine secretion after glucagon infusion on the patients that were operated with a subtotal pancreatectomy
Acronym
An observation study of pancreatic endocrine secretion on the patients after tumor removal by subtotal pancreatectomy
Scientific Title
An observation study of pancreatic endocrine secretion after glucagon infusion on the patients that were operated with a subtotal pancreatectomy
Scientific Title:Acronym
An observation study of pancreatic endocrine secretion on the patients after tumor removal by subtotal pancreatectomy
Region
| Japan |
Condition
Condition
Pancreatic biliary tract disease including malignant disorders is planned a subtotal pancreatectomy
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
An observation study of endocrine pancreatic endocrine secretion after glucagon injection on the patients, have pancreatic biliary disease including malignant disorders, were operated with a subtotal pancreatectomy
Basic objectives2
Others
Basic objectives -Others
Labolatory parameter
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Delta C-peptide in glucagon injection.
(delta C-peptide = max C-peptide - base C-peptide)
Observation of the mean of delta C-peptide from before to the end of study.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(a) Patients were underwent subtotal pancreatectomy.
(b) Patients are outpatients or inpatients
(c) Patients need anti-diabetic agents after subtotal pancreatectomy.
(d) Patients with a therapy of diabetes mellitus before subtotal pancreatectomy.
Key exclusion criteria
(a) Patients with a history of total pancreatectomy.
(b) Patients with insulin-dependent diabetes mellitus.(Fatigue serum C-peptide under 0.5 ng/ml or 24hr C-peptide under 20 microg/day)
(c) Patients with a history of severe cardiovascular or cerebrovascular disease or renal failure.
(d) Patients have contraindication of glucagon.
(e) Patients with severe liver damage.
(f) Patients are pregnant or patients breast-feeding, potentially pregnant.
(g) Patients who are diagnosed to be ineligible by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuhei Nakanishi |
Organization
Hiroshima University Hospital
Division name
Department of Endocrinology and Diabetes mellitus
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL
082-257-5198
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuguka Shiwa |
Organization
Hiroshima University Hospital
Division name
Department of Endocrinology and Diabetes mellitus
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL
082-257-5198
Homepage URL
tsuguka@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Department of Endocrinology and Diabetes mellitus
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2010 | Year | 12 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study about the pancreatic endocrine secretion in a patient after subtotal pancreatectomy
Management information
Registered date
| 2010 | Year | 12 | Month | 01 | Day |
Last modified on
| 2019 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005138
