UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000500 |
|---|---|
| Receipt number | 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 20:30:33 |
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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
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
nakahary@hmj-net.hosp.go.jp
Sponsor or person
Institute
Department of Respiratory Medicine, National Hospital Organization, Himeji 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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000605
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| Registered date | File name |
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