UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016451 |
|---|---|
| Receipt number | R000019108 |
| Scientific Title | Confirmatory clinical trial about safeness of perioperative blood glucose management using artificial pancreas in division of hepato-pancreato-biliary surgery |
| Date of disclosure of the study information | 2015/02/09 |
| Last modified on | 2018/03/20 14:30:12 |
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Basic information
Public title
Confirmatory clinical trial about safeness of perioperative blood glucose management using artificial pancreas in division of hepato-pancreato-biliary surgery
Acronym
Clinical trial about safeness of perioperative blood glucose management using artificial pancreas in hepato-pancreato-biliary surgery
Scientific Title
Confirmatory clinical trial about safeness of perioperative blood glucose management using artificial pancreas in division of hepato-pancreato-biliary surgery
Scientific Title:Acronym
Clinical trial about safeness of perioperative blood glucose management using artificial pancreas in hepato-pancreato-biliary surgery
Region
| Japan |
Condition
Condition
1) Hepatectomy above 2 sectors
2) Pansreatoduodenectomy
3) Liver transplantation
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm safeness of erioperative blood glucose management using artificial pancreas after hepato-pancreato-biliary surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of hypoglycemia under 60mg/dL
Key secondary outcomes
1) Incidence of postoperative infectious complications during hospitalization
2) Stability of blood glucose level (target level: 80~110mg/dL)
3) Compalison of blood glucose accuracy between artificial pancreas and conventional method
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Blood glucose management using artificial pancreas (24 hours)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients received high invasive surgery.
a) Hepatectomy above 2 sectors
b) Pancreatoduodenectomy
c) Liver transplantation
2) ECOG Performance Status Scale: 0~2.
3) Without active infection before surgery.
4) Age between 20y.o. to 80y.o.
5) Clean to clean-contaminated wound.
Key exclusion criteria
1) Case of other organ excision.
2) Case of pregnant, breast-feeding and possible pregnant woman.
3) ASA score over 4.
4) Other inadequate case judged by study participated doctor.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Takamura |
Organization
Kanazawa University Hospital
Division name
Department of Hepato-Pancreato-Biliary and Transplant Surgery
Zip code
Address
13-1, Takara-machi, Kanazawa
TEL
076-265-2362
takamuh@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironori Hayashi |
Organization
Kanazawa University Hospital
Division name
Department of Hepato-Pancreato-Biliary and Transplant Surgery
Zip code
Address
13-1, Takara-machi, Kanazawa
TEL
076-265-2362
Homepage URL
pwrofdrms2000@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterologic Surgery, Division of Cancer Medicine, Graduate School of Medical Science, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterologic Surgery, Division of Cancer Medicine, Graduate School of Medical Science, Kanazawa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 05 | Day |
Last modified on
| 2018 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019108
| 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 |
