UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048616 |
|---|---|
| Receipt number | R000053486 |
| Scientific Title | Time course change of the insulin requirements during the perioperative period in hepatectomy and pancreatectomy by using an artificial pancreas STG-55. |
| Date of disclosure of the study information | 2022/08/07 |
| Last modified on | 2024/08/08 23:25:47 |
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Basic information
Public title
Effectiveness of artificial pancreas in perioperative glycemic control
Acronym
Effectiveness of artificial pancreas in perioperative glycemic control
Scientific Title
Time course change of the insulin requirements during the perioperative period in hepatectomy and pancreatectomy by using an artificial pancreas STG-55.
Scientific Title:Acronym
Time course change of the insulin requirements during the perioperative period in hepatectomy and pancreatectomy by using an artificial pancreas STG-55.
Region
| Japan |
Condition
Condition
Diabetes mellitus, Hepatocellular carcinoma, Pancreatic cancer
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We compare changes in insulin requirements over time by organ and surgical procedure in hepatectomy and pancreatectomy in which blood glucose was controlled with an artificial pancreas during the perioperative period.We also investigate factors influencing perioperative insulin dosage.This study is a retrospective observational study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Clinical findings (age, gender, height, weight, medical history, medicine, bleeding volume, pringle time, surgical time, length of hospital stay)
2) Blood findings (blood glucose level, HbA1c, C-peptide)
3) Artificial pancreas (IA value, IB value, insulin injection rate, glucose injection rate, total insulin dose, blood glucose level)
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent hepatectomy or pancreatectomy using an artificial pancreas at the Department of Surgery,Okayama saiseikai hospital between February 2016 and April 2020.
Key exclusion criteria
(1) Patients who the researcher deems unsuitable as a research subject.
(2) Patients who have been offered to not participate in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sanae |
| Middle name | |
| Last name | Teshigawara |
Organization
Okayama Saiseikai General Hospital
Division name
Internal Medicine / Diabetes Center
Zip code
700-8511
Address
2-25 Kokutaicho, Kita-ku, Okayama, Japan
TEL
086-252-2211
sanaea@nifty.com
Public contact
Name of contact person
| 1st name | Sanae |
| Middle name | |
| Last name | Teshigawara |
Organization
Okayama Saiseikai General Hospital
Division name
Internal Medicine / Diabetes Center
Zip code
700-8511
Address
2-25 Kokutaicho, Kita-ku, Okayama, Japan
TEL
086-252-2211
Homepage URL
sanaea@nifty.com
Sponsor or person
Institute
Okayama Saiseikai General Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama Saiseikai General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Saiseikai General Hospital
Address
2-25 Kokutaicho, Kita-ku, Okayama, Japan
Tel
086-252-2211
chiken-hp@okayamasaiseikai.or.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
| 2022 | Year | 08 | Month | 07 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s13340-023-00623-3
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1007/s13340-023-00623-3
Number of participants that the trial has enrolled
56
Results
The mean intraoperative blood glucose level and total insulin doses were higher in the hepatectomy group than in
the pancreatectomy group. The dose of insulin infusion increased in hepatectomy, especially early in surgery, compared to
pancreatectomy. In the hepatectomy group, there was a significant correlation between the total intraoperative insulin dose
and Pringle time, and in all cases, there was a correlation with surgical time, bleeding volume, preoperative CPR, preoperative
TDD, and weight.
Results date posted
| 2024 | Year | 08 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
It included 22 hepatectomies and 34 pancreatectomies performed at Okayama Saiseikai General Hospital from February 2016 to April 2020 and in which perioperative blood glucose was managed using the closed-loop bedside artificial pancreas STG-55 (NIKKISO, Tokyo) for approximately 24 h from the induction of anesthesia to the morning following surgery.
Participant flow
With the STG-55 system, a small amount of blood is continuously collected (2 ml/h)from a 20G catheter placed in a peripheral vein, and blood glucose levels are measured every 0.1 s using the glucose oxidase method. The optimal glucose and insulin infusion rates are calculated every minute to achieve a target blood glucose level, and both are automatically infused intravenously.The algorithm employed is expressed by the following equation. Insulin infusion rate = Proportional coefficient (IA) x (Blood glucose level-target blood glucose level)/100 + Differential coefficient (IB) x Rate of change in blood glucose level/100 + 0.225 (Regular injection amount), Glucose infusion rate = Proportional coefficient (GA) x (Target blood glucose level-blood glucose level) + Differential coefficient (GB) x Rate of change in blood glucose level + 0 (Regular injection amount)
Adverse events
none
Outcome measures
We evaluated 24-h blood glucose and insulin infusion rate profiles, mean blood glucose levels, and the total intraoperative and 24-h insulin and glucose doses for each surgical procedure. We also performed a correlation analysis of the total intraoperative and 24-h insulin doses with Pringle time, surgical time, bleeding volume, preoperative fasting C-peptide immune reactivity (CPR), HbA1c, total daily dose of insulin (TDD), and body weight.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2022 | Year | 08 | Month | 07 | Day |
Last modified on
| 2024 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053486
