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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007586
Receipt No. R000008882
Scientific Title Clinical efficacy of pleural blood patching to reduce the need for chest tube placement for pneumothorax associated with CT-guided percutaneous lung biopsy
Date of disclosure of the study information 2012/03/27
Last modified on 2015/02/10

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Basic information
Public title Clinical efficacy of pleural blood patching to reduce the need for chest tube placement for pneumothorax associated with CT-guided percutaneous lung biopsy
Acronym Clinical efficacy of pleural blood patching to reduce the need for chest tube placement for pneumothorax associated with CT-guided percutaneous lung biopsy
Scientific Title Clinical efficacy of pleural blood patching to reduce the need for chest tube placement for pneumothorax associated with CT-guided percutaneous lung biopsy
Scientific Title:Acronym Clinical efficacy of pleural blood patching to reduce the need for chest tube placement for pneumothorax associated with CT-guided percutaneous lung biopsy
Region
Japan

Condition
Condition Patients who receive CT-guided lung biopsies
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of pleural
blood pleural for reducing the need for chest tube placement for pneumothorax associated with CT-guided percutaneous lung biopsy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of chest tube placement for pneumothorax associated with CT-guided percutaneous lung biopsy
Key secondary outcomes 1.Rate of pneumothorax associated with CT-guided percutaneous lung biopsy
2.Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Pleural blood patching
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 1.Patients aged 20 years and more.
2.Patients who receive CT-guided lung biopsies.
3.Written informed consent.
Key exclusion criteria 1.Patients who are unable to drawn
blood for this study.
2.Patients who are suspected of having active lung infectious diseases.
3.Inappropriate patients for this study judged by the physicians.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuma Kishi
Organization Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
Division name Department of Respiratory Medicine, Respiratory Center
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JAPAN
TEL 03-3588-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
Division name Department of Respiratory Medicine, Respiratory Center
Zip code
Address
TEL 03-3588-1111
Homepage URL
Email

Sponsor
Institute Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
Institute
Department

Funding Source
Organization Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
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
Address
Tel
Email

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
2012 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2014.189.1_MeetingAbstracts.A4411
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 Completed
Date of protocol fixation
2012 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 27 Day
Last modified on
2015 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008882

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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