Study on the utility of ultrathin bronchoscopy in the diagnosis of non-tuberculous mycobacterial pulmonary disease

JRCT ID: jRCT1052240011

Registered date:17/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pulmonary nontuberculous mycobacterial disease
• Date of first enrollment: 26/02/2024
• Target sample size: 40
• Study type: Observational

Outcome(s)

• Primary Outcome: Positivity rate (number of culture-positive cases/number of cases in the analyzed population)

Secondary Outcome

True positive rate
number of culture-positive cases/(number of cases in the analyzed population - number of true negative cases).
The true positivity rate is defined as the ratio of the number of culture-positive cases to the number of true-negative cases (see below), which is subtracted from the number of cases in the analysis population defined as the positivity rate for the primary endpoint.
True negative cases: Cases that are culture-negative in various specimens and meet either of the following conditions: 1) or 2). In such cases, improvement or final diagnosis should also be noted in the report.
1) Patients who have been treated with no treatment or treatment other than pulmonary non-tuberculous mycobacteriosis, and the negative result of CT scan of the chest has improved after 6 months.
2) Cases in which a diagnosis other than pulmonary non-tuberculous Mycobacterium tuberculosis was made within 6 months.
The results of smear test of each specimen (aspirated sputum, brush specimen, transbronchial biopsy specimen, and bronchial lavage fluid) collected by ultrafine bronchoscopy.
Nucleic acid amplification test of each specimen collected by ultrafine bronchoscope (aspirated sputum, brush swab specimen, transbronchial biopsy specimen, and bronchial lavage fluid)
Sensitivity, specificity, positive predictive value, negative predictive value, and positive predictive value calculated from the test results of each specimen.
Results of tissue and cell diagnosis of bronchial biopsy
Total examination time
Amount of sedatives and analgesics used during the test
Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include criteria

1) Patients with clinically suspected pulmonary non-tuberculous mycobacterial infection such as nodular or cavernous shadows or other characteristic images on chest CT
2) Patients scheduled for bronchoscopy for 1
3) Patients who are 20 years of age or older at the time of the bronchoscopy
4) Patients who have given written consent to participate in the study.

Exclude criteria

1) Patients with sputum culture positive for Mycobacterium tuberculosis from two or more sputum samples.
2) Patients with a history of treatment for pulmonary non-tuberculous Mycobacterium tuberculosis in the past.
3) Patients with confirmed or clinically suspected pulmonary tuberculosis.
4) Patients with poorly controlled complications (unstable angina, acute myocardial infarction, severe bronchial asthma, active pulmonary infection, heart failure, bleeding tendency, cerebral infarction, etc.) or psychiatric disorders or psychiatric symptoms that interfere with daily life, which make participation in the study difficult.
5) Other cases that the investigator deems inappropriate for inclusion in the study.

Related Information

• Primary Sponsor: Tomoya Kawaguchi