Additional fine needle aspiration for peripheral pulmonary lesions accompanied with interstitial lung disease

JRCT ID: jRCT1042230076

Registered date:05/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Peripheral pulmonary lesions accompanied with interstitial lung disease
• Date of first enrollment: 05/09/2023
• Target sample size: 48
• Study type: Interventional
• Intervention(s): We perform transbronchial needle aspiration in addition to transbronchial biopsy using endobronchial ultrasonography with a guide sheath (EBUS-GS) to diagnose peripheral pulmonary lesions in patients with interstitial lung disease.

Outcome(s)

• Primary Outcome: The diagnostic yield based on histological or cytological findings via transbronchial biopsy or fine needle aspiration

Secondary Outcome

1. The improvement rate of Radial EBUS images
We classify the positional relation of the R-EBUS probe with the lesion into three groups as follows: a) within, when the probe is located inside the lesion; b) adjacent to, when the probe is located at the periphery of the lesion; c) outside, when the probe is located outside the lesion.

We set the improvement of the EBUS images as follows: when the EBUS image of 'adjacent to' changed to 'within' or the image of 'invisible' changed to 'adjacent to' or 'within', the EBUS imaging is considered to have improved.

2. The examination time

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with a peripheral pulmonary lesion who need to undergo diagnostic bronchoscopy
2. 18 years old or older
3. The presence of interstitial lung disease on chest computed tomography
4. The informed consent

Exclude criteria

1. Lesion located within the inner third ellipse from the hilum on chest computed tomography
2. Patients needing to undergo diagnotic bronchoscopy for non-target lesion in the same setting
3. Women who are pregnant or may become pregnant
4. Patients who are unable to temporarily discontinue antiplatelet or anticoagulant medications for this study
5. Severe bleeding tendency
6. Other clinical difficulties in this trial

Related Information

• Primary Sponsor: Ishii Makoto
• Source(s) of Monetary Support: The Japanese Foundation for Research and Promotion of Endoscopy Grant