EBUS Image Features in the Diagnosis of PPLs

Study Overview
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Brief Summary
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The study is aimed to evaluate the sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate of endobronchial ultrasound (EBUS) image features in diagnosing peripheral pulmonary lesions (PPLs).

Detailed Description
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The study is designed as a single center prospective trial. The participating center is Department of Ultrasound, Shanghai chest Hospital, Shanghai Jiao Tong University, China. The study is expected to enroll 200 patients. The investigator evaluates the sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate of EBUS image features in diagnosing PPLs. EBUS is performed using an endoscope ultrasound system, which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm.

Official Title
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Endobronchial Ultrasound Image Features in the Diagnosis of Peripheral Pulmonary Lesions

Conditions
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Endobronchial Ultrasound

Intervention / Treatment
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* Device: EBUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are older than 18 year-old. Chest CT shows PPLs suspected to be malignant that need to be confirmed by pathology. The lesion is surrounded by lung parenchyma and invisible in standard bronchoscopy. Patients who agree to undergo bronchoscopy without any contraindications. Patients who have good compliance and sign informed consent. Exclusion Criteria: Absence of bronchus leading to or adjacent to the lesion from CT scan. Refusal of participation. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy. Presence of concomitant endobronchial lesion during the bronchoscopy procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBUS group<br>EBUS and guide sheath (GS) are inserted into bronchi in the assistance of navigation bronchoscopy. The EBUS probe and GS are confirmed to reach the lesion by EBUS images, cytologic and pathologic specimens are obtained with or without fluoroscopic guidance. | Device: EBUS<br>* EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic value of EBUS image features | The diagnostic value includes sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EBUS image features of adenocarcinoma | Making invasive EBUS image features of adenocarcinoma and non-invasive adenocarcinoma | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endobronchial ultrasound, peripheral pulmonary lesions, image features