UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031911 |
|---|---|
| Receipt number | R000036422 |
| Scientific Title | The clarification of the immunosuppression mechanism of propofol, desflurane, and sevoflurane during lung cancer surgery and its effect on patients' outcome. |
| Date of disclosure of the study information | 2018/04/15 |
| Last modified on | 2024/04/02 15:27:43 |
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Basic information
Public title
The clarification of the immunosuppression mechanism of propofol, desflurane, and sevoflurane during lung cancer surgery and its effect on patients' outcome.
Acronym
The immunosuppression mechanism of intraoperative anesthetics during lung cancer surgery and its effect on the outcome.
Scientific Title
The clarification of the immunosuppression mechanism of propofol, desflurane, and sevoflurane during lung cancer surgery and its effect on patients' outcome.
Scientific Title:Acronym
The immunosuppression mechanism of intraoperative anesthetics during lung cancer surgery and its effect on the outcome.
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The differences of immunosuppression mechanism among propofol, desflurane, and sevoflurane, which may prevent the postoperative complication and the recurrence, should clarified and then it will contribute the improvement of prognosis in lung cancer patients.
Basic objectives2
Others
Basic objectives -Others
It is investigated relationship differences in degree of immunosuppression and patients outcome.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 The ratio of neutrophils, monocytes, and lymphocytes in the peripheral blood leukocyte
2 Evaluation of CD4/CD8 ratio, naive memory cell ratio, T cell exhaustion status.
3 Percentage of postoperative complications and recurrence
4 Duration of hospitalization, the mortality.
The above items are analyzed from the blood samples at the 6 points, which includes preoperative, intraoperative (beginning and end of surgery), postoperative (1,3,5 POD), and are compared among three anesthetics groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lung cancer patients who are enrolled the study are divided into the three group ,propofol, sevoflurane, and desflurane, as follow as randomized rule.
1 propofol group
Interventions/Control_2
Lung cancer patients who are enrolled the study are divided into the three group ,propofol, sevoflurane, and desflurane, as follow as randomized rule.
2 desflurane group
Interventions/Control_3
Lung cancer patients who are enrolled the study are divided into the three group ,propofol, sevoflurane, and desflurane, as follow as randomized rule.
3 sevoflurane group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient should be over 20 years old at agreement of research is obtained.
2 the Surgery is of one side.
3 A patient with primary and metastatic lung cancer
4 patient should paerticipate who agreed document consent by free will of the research subject after having sufficient explanation for participation in this research.
Key exclusion criteria
1 Patients taking immunosuppressants and steroids
2 Patients already had undergone chemoradiotherapy
3 Patients who is going to undergo lung surgery on both sides at the same time.
4 Patients with autoimmune diseases such as collagen disease
5 Patients who had been judged by the research director as inappropriate as the research subject .
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Kawagoe |
Organization
Juntendo University, Faculty of Medicine.
Division name
Department of Anesthesiology and Pain clinic
Zip code
113-8431
Address
2-1-1Hongo, Bunkyo-ku, Tokyo, Japan.
TEL
0338133111
ikawago@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Kawagoe |
Organization
Juntendo University
Division name
Department of Anesthesiology and Pain clinic
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo.
TEL
0338133111
Homepage URL
ikawago@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
No fundation
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
IRB of Juntendo University Hospital
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel
0338133111
kenkyu5858@juntendo.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
| 2018 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://tcr.amegroups.com/article/view/62230/html
Number of participants that the trial has enrolled
160
Results
Results: Eighty-two patients were enrolled; samples from 64 individuals (20 in group D, 22 in group S,
and 22 in group P) were analysed after exclusion. The number of CD8+ T cells was significantly lower after
the operation than before the operation in the group P (P<0.05). The proportion of regulatory T cells was
significantly increased after surgery, compared with before surgery in the group S (P<0.05). There was no
difference in PD-1 on CD4+ and CD8+ T cells after lung surgery among the three groups.
Results date posted
| 2024 | Year | 04 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent scheduled resection for primary
lung cancer at Juntendo University Hospital were enrolled
from June 13, 2018 to July 24, 2019. Exclusion criteria included a lack of informed consent, age
less than 20 years, immunological disease, pre-treatment
with chemoradiotherapy, taking immunosuppressive agents
or steroids, and simultaneous bilateral surgery.
Participant flow
This study was a
three-arm parallel study and allocation ratio was closed
to 1:1:1. The patients were randomly divided to three
groups regarding to general anaesthesia methods [volatile
desflurane (group D), volatile sevoflurane (group S),
and intravenous propofol (group P)]. On acquiring the
written informed consent from the participant on the day
before surgery, they were randomized into each group
by using permuted block randomization, in sequence of
registration. The permuted blocks including 25 for each
group had been made by Juntendo Clinical Research and
Trial Center in advance immediately after IRB approval.
Adverse events
None
Outcome measures
The primaryy endpoint is to measure the changes in the number of immune response cells.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036422
| 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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