EBUS Image Features in the Diagnosis of PPLs

Shanghai Jiao Tong University

Status: Unknown

Conditions: Endobronchial Ultrasound

Treatments: Device: EBUS

Study type: Interventional

Funder types: Other

Identifiers

NCT03575715

Chest007

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who are older than 18 year-old.
2. 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.
3. Patients who agree to undergo bronchoscopy without any contraindications.
4. Patients who have good compliance and sign informed consent.

Exclusion criteria

1. Absence of bronchus leading to or adjacent to the lesion from CT scan.
2. Refusal of participation.
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
4. Presence of concomitant endobronchial lesion during the bronchoscopy procedure

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

EBUS group

Experimental group

Description:

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.

Treatment:

Device: EBUS