UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053087 |
|---|---|
| Receipt number | R000060570 |
| Scientific Title | Association with time in range, a new index for glycemic control, and organ/space SSI after pancreatectomy: Multicenter retrospective observational study |
| Date of disclosure of the study information | 2023/12/20 |
| Last modified on | 2023/12/19 15:50:45 |
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Basic information
Public title
Association with time in range, a new index for glycemic control, and organ/space SSI after pancreatectomy: Multicenter retrospective observational study
Acronym
Association with time in range, a new index for glycemic control, and organ/space SSI after pancreatectomy: Multicenter retrospective observational study
Scientific Title
Association with time in range, a new index for glycemic control, and organ/space SSI after pancreatectomy: Multicenter retrospective observational study
Scientific Title:Acronym
Association with time in range, a new index for glycemic control, and organ/space SSI after pancreatectomy: Multicenter retrospective observational study
Region
| Japan |
Condition
Condition
Diseases requiring pancreatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the relationship between time in range, a new glycemic control index, and infectious complications after pancreatectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Development of infectious complications after 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A case of 4 blood glucose tests per day for 1 week after pancreatectomy
Key exclusion criteria
A cases of peritonitis diagnosed preoperatively
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Sho |
Organization
Nara medical university
Division name
Department of surgery
Zip code
6348521
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744223051
m-sho@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Kohara |
Organization
Nara medical university
Division name
Department of surgery
Zip code
6348521
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744223051
Homepage URL
kohara@naramed-u.ac.jp
Sponsor or person
Institute
Nara medical university
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
Nara medical university
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744223051
ino_rinri@naramed-u.ac.jp
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
| 2023 | Year | 12 | Month | 20 | 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
| 2023 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will retrospectively collect the following medical information from electronic medical records of patients who underwent pancreatectomy at Nara Medical University and Wakayama Medical University from January 2017 to December 2022.
Clinical findings: age (at surgery), gender, height (at surgery), weight (at surgery), body mass index (at surgery), use of insulin, history of diabetes, last diagnosis, preoperative yellowing treatment
Blood findings: lymphocyte count, serum albumin level, eGFR, HbA1c level, blood glucose level
Surgical findings: surgical procedure, complications, operation time, blood loss, blood transfusion
Perioperative information: length of hospital stay after surgery, postoperative complications (Clavien-Dindo classification), pancreatic fluid leak (ISGPF), postoperative infection complications, and death in hospital.
Based on this information, we will evaluate blood glucose trends after pancreatectomy by TIR and examine the relationship with infectious complications.
Management information
Registered date
| 2023 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060570
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
