UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023460 |
|---|---|
| Receipt number | R000027033 |
| Scientific Title | The efficacy and safety of perioperative blood glucose management using artificial pancreas in patients with hepato-pancreato-biliary surgery |
| Date of disclosure of the study information | 2016/08/05 |
| Last modified on | 2019/03/05 10:07:09 |
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Basic information
Public title
The efficacy and safety of perioperative blood glucose management using artificial pancreas in patients with hepato-pancreato-biliary surgery
Acronym
The efficacy and safety of perioperative blood glucose management using artificial pancreas
Scientific Title
The efficacy and safety of perioperative blood glucose management using artificial pancreas in patients with hepato-pancreato-biliary surgery
Scientific Title:Acronym
The efficacy and safety of perioperative blood glucose management using artificial pancreas
Region
| Japan |
Condition
Condition
Hepatectomy above 1 sector
Pancreatoduodenectomy
Distal pancreatectomy
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety (hypoglycemic attack) and efficacy (postoperative complications and hospital days)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of postoperative complications
Key secondary outcomes
1) Perioperative blood glucose values, glycemic variability
2) Postoperative hospital days
3) inflammation-related factors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Treatment Group (Target blood glucose range is from 80 to 110 mg/dl)
Interventions/Control_2
Control Group (Target blood glucose range is from 80 to 180 mg/dl)
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients received following surgery
a) Hepatectomy above 1 sector
b) Pancreatoduodenectomy
c) Distal pancreatectomy
2) ECOG Performance Status Scale: 0-1
3) Patients with impaired glucose tolerance
4) Age between 20 y.o. to 85 y.o.
Key exclusion criteria
1)Patients with severe respiratory disease
2)Dialysis patients with chronic renal failure
3)Other inadequate case judged by study participated doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroya Akabori |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2238
hakabori@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroya Akabori |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2238
Homepage URL
hakabori@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
NIKKISO CO,.LTD
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 08 | Month | 05 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 03 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027033
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
