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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000500
Receipt No. R000000605
Scientific Title Availability of percutaneous needle washing for the diagnosis of pulmonary thin-walled cavitary lesions filled with air.
Date of disclosure of the study information 2006/10/10
Last modified on 2007/08/12

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Basic information
Public title Availability of percutaneous needle washing for the diagnosis of pulmonary thin-walled cavitary lesions filled with air.
Acronym Availability of percutaneous needle washing for the diagnosis of pulmonary thin-walled cavitary lesions filled with air.
Scientific Title Availability of percutaneous needle washing for the diagnosis of pulmonary thin-walled cavitary lesions filled with air.
Scientific Title:Acronym Availability of percutaneous needle washing for the diagnosis of pulmonary thin-walled cavitary lesions filled with air.
Region
Japan

Condition
Condition Pulmonary thin-walled cavitary lesions filled with air
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Sputum examination and the bronchoscopic technique may be performed in an attempt to diagnose pulmonary thin-walled cavitary lesions. However, in our experience, a diagnosis cannot always be established in these lesions by sputum examination or the bronchoscopic technique, and surgical biopsy is occasionally needed, which is a highly invasive method. Millard and Westcott reported a method of percutaneous needle washing for the diagnosis of cavitary lesions of the lung, in which normal saline is injected into the cavity and then aspirated (Radiology 1974;111:474). We aim to ascertain the diagnostic significance and the safety of percutaneous needle washing method in the diagnosis of pulmonary thin-walled cavitary lesions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The specimen obtained by percutaneous needle washing method is analyzed by cytological and microbiological examinations. Sensitivity and specificity of this method in the diagnosis of pulmonary thin-walled cavitary lesions is observed. The final diagnosis of each patient is confirmed by either surgery or clinical follow-up of more than one year.
Key secondary outcomes The clinical observation of more than one year after the procedure for each patient is required to monitor the potential complications of percutaneous needle washing method; short-term complications (pneumothorax, hemoptysis, cough, air embolism, etc.) and long-term complications (invasion of the cancer, spread of the infection, etc.).

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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 Percutaneous needle washing is performed for pulmonary thin-walled cavitary lesions whose diagnosis can not be established by sputum examination or bronchoscopic procedures.
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 with pulmonary thin-walled cavitary lesions whose diagnosis can not be established by sputum examination or bronchoscopic procedures.
Key exclusion criteria Patients with bleeding tendency or allergy to local anesthetics. Patients who do not give informed consent to participate in the study.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuharu Nakahara
Organization National Hospital Organization, Himeji Medical Center
Division name Respiratory Medicine
Zip code
Address Honmachi 68, Himeji-city 670-8520 Japan
TEL 079-225-3211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuharu Nakahara
Organization National Hospital Organization, Himeji Medical Center
Division name Respiratory Medicine
Zip code
Address Honmachi 68, Himeji-city 670-8520 Japan
TEL 079-225-3211
Homepage URL
Email nakahary@hmj-net.hosp.go.jp

Sponsor
Institute Department of Respiratory Medicine, National Hospital Organization, Himeji Medical Center
Institute
Department

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
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
2006 Year 10 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Published in Intern Med. 2007;46(14):1089-94
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
2000 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2000 Year 09 Month 01 Day
Last follow-up date
2006 Year 09 Month 01 Day
Date of closure to data entry
2006 Year 10 Month 01 Day
Date trial data considered complete
2006 Year 10 Month 01 Day
Date analysis concluded
2006 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 10 Month 09 Day
Last modified on
2007 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000605

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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