UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055755 |
|---|---|
| Receipt number | R000063721 |
| Scientific Title | Safety and efficacy of CT-guided lung biopsy and drainage for the management of intrathoracic infections |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/04/06 10:09:12 |
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Basic information
Public title
Safety and efficacy of CT-guided lung biopsy and drainage for the management of intrathoracic infections
Acronym
CT-guided lung biopsy and drainage for the management of intrathoracic infections
Scientific Title
Safety and efficacy of CT-guided lung biopsy and drainage for the management of intrathoracic infections
Scientific Title:Acronym
CT-guided lung biopsy and drainage for the management of intrathoracic infections
Region
| Japan |
Condition
Condition
Respiratory Infections
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate CT-guided lung biopsies and drainage performed for respiratory tract infections and to determine their efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic rates of CT-guided lung biopsy and treatment success rates of CT-guided drainage.
Key secondary outcomes
Safety of CT-guided lung biopsy and drainage.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone CT-guided lung biopsy or CT-guided drainage in our hospital.
Patients whose medical information and progress can be checked in the electronic medical record.
Key exclusion criteria
Patients who have been offered refusal to participate in research.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Fujita |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
612-8555
Address
1-1, Fukakusa-Mukaihata Fushimi, Kyoto
TEL
0756419161
kfujita.acd@gmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Fujita |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
6128555
Address
1-1, Fukakusa-Mukaihata, Fushimi, Kyoto
TEL
0756419161
Homepage URL
kfujita.acd@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
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
National Hospital Organization Kyoto Medical Center
Address
1-1, Fukakusa-Mukaihata, Fushimi, Kyoto
Tel
0756419161
kfujita.acd@gmail.com
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
| 2024 | Year | 11 | Month | 01 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | 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
As this is a retrospective study, a medical record review will be conducted from the study start date to extract medical information.
Management information
Registered date
| 2024 | Year | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063721
