UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041800 |
|---|---|
| Receipt number | R000045932 |
| Scientific Title | Quantitative and qualitative evaluation in residual lung after lung resection surgery |
| Date of disclosure of the study information | 2020/09/17 |
| Last modified on | 2021/09/16 11:50:01 |
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Basic information
Public title
Quantitative and qualitative evaluation in residual lung after lung resection surgery
Acronym
Quantitative and qualitative evaluation in residual lung after lung resection surgery
Scientific Title
Quantitative and qualitative evaluation in residual lung after lung resection surgery
Scientific Title:Acronym
Quantitative and qualitative evaluation in residual lung after lung resection surgery
Region
| Japan |
Condition
Condition
The patients who will undergo lung resection
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to detect the increase in the residual lung after lung resection, with using a reconstruction application on CT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The volume of the residual lung after lung resection and the size and the number in the empysematous lung
Key secondary outcomes
Results of spirometory
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who will undergo lung resection.
Key exclusion criteria
The patients who had undergone lung resection and the patients who had and will have surgery for pneumothorax, lung abscess and thoracoplasty.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Nakahira |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Anesthesiology
Zip code
569-8686
Address
3-5-7
TEL
09098748678
junko.nakahira@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | Nakahira |
| Last name | Nakahira |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Anesthesiology
Zip code
569-8686
Address
2-7 DAIGAKU-MACHI
TEL
0726831221
Homepage URL
junko.nakahira@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research <KAKENHI>
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Osaka Medical and Pharmaceutical University
Address
2-7 DAIGAKU-MACHI
Tel
+81726831221
rinri@osaka-med.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
大阪医科薬科大学病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
This is a prospective observational study. We need to get informed consent from all the patients who join in this study.
Management information
Registered date
| 2020 | Year | 09 | Month | 15 | Day |
Last modified on
| 2021 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045932
| Research Plan | |
|---|---|
| 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 |
