UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044253 |
|---|---|
| Receipt number | R000050545 |
| Scientific Title | A prospective observational study on the usefulness of chest dynamic digital radiography in the perioperative management of thoracic surgery |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2023/05/22 10:25:12 |
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Basic information
Public title
A prospective observational study on the usefulness of chest dynamic digital radiography in the perioperative management of thoracic surgery
Acronym
A prospective observational study on the usefulness of chest dynamic digital radiography in the perioperative management of thoracic surgery
Scientific Title
A prospective observational study on the usefulness of chest dynamic digital radiography in the perioperative management of thoracic surgery
Scientific Title:Acronym
A prospective observational study on the usefulness of chest dynamic digital radiography in the perioperative management of thoracic surgery
Region
| Japan |
Condition
Condition
Lung tumor, mediastinal tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the findings of dynamic digital radiography for evaluation of pulmonary function and the effectiveness of dynamic evaluation index in the perioperative thoracic surgery.
Basic objectives2
Others
Basic objectives -Others
To clarify the dynamic digital radiographic findings of tumor infiltration and adhesions of the pleura.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the correlation between findings from standard tests such as respiratory function tests, CT and nuclear medicine tests and findings obtained from digital dynamic radiography.
Key secondary outcomes
To evaluate the correlation between intraoperative findings of pleural adhesion and those obtained from dynamic digital radiography.
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
Patients scheduled for surgery for the lung or mediastinal tumor who understand the purpose of this study and have given written informed consent.
Key exclusion criteria
1) Patients for whom moving to the imaging room is physically burdened
2) Patients with pacemakers inserted
3) Patients who are pregnant or breastfeeding
4) Patients who require urgent treatment
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yukimi |
| Middle name | |
| Last name | Shibuya |
Organization
Kyorin University
Division name
Thoracic and Thyroid Surgery
Zip code
1810004
Address
6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL
+81422475511
yukimi@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukimi |
| Middle name | |
| Last name | Shibuya |
Organization
Kyorin University
Division name
Thoracic and Thyroid Surgery
Zip code
1810004
Address
6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL
+81422475511
Homepage URL
yukimi@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Konica Minolta
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University
Address
6-20-2 Shinkawa, Mitaka, Tokyo, Japan
Tel
+81422475511
rec@ks.kyorin-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
| 2021 | Year | 05 | Month | 31 | 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
| 2021 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the correlation between findings from standard tests such as respiratory function tests, CT and nuclear medicine tests and findings obtained from digital dynamic radiography.
To evaluate the correlation between intraoperative findings of pleural adhesion and those obtained from dynamic digital radiography.
Management information
Registered date
| 2021 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050545
