Availability of percutaneous needle washing for the diagnosis of pulmonary thin-walled cavitary lesions filled with air.

UMIN ID: UMIN000000500

Registered date:10/10/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Pulmonary thin-walled cavitary lesions filled with air
• Date of first enrollment: 2000/09/01
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Percutaneous needle washing is performed for pulmonary thin-walled cavitary lesions whose diagnosis can not be established by sputum examination or bronchoscopic procedures.

Outcome(s)

• Primary Outcome: 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.
• Secondary Outcome: 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.).

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients with bleeding tendency or allergy to local anesthetics. Patients who do not give informed consent to participate in the study.

Related Information

• Primary Sponsor: Department of Respiratory Medicine, National Hospital Organization, Himeji Medical Center
• Source(s) of Monetary Support: none