ENB in the Diagnosis of Peripheral Pulmonary Nodules

Shanghai Jiao Tong University

Status: Unknown

Conditions: Peripheral Pulmonary Nodules

Treatments: Device: EBUS-GS; Device: ENB

Study type: Interventional

Funder types: Other

Identifiers

NCT03569306

2017YFC0112701-1

Details and patient eligibility

About

The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.

Full description

The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.

Enrollment: 400 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 peripheral pulmonary nodule (8mm<longest diameter≤30mm) suspected to be malignant that need to be confirmed by pathology. The nodule 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. Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
2. Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

ENB-EBUS-GS group

Experimental group

Description:

ENB is used in this group.EBUS and GS are inserted into bronchi in the assistance of ENB. The EBUS probe and GS are confirmed to reach the lesion by EBUS images.

Treatment:

Device: ENB

Device: EBUS-GS

EBUS-GS group

Active Comparator group

Description:

ENB isn't used in this group.EBUS and GS are inserted into bronchi according to the chest CT that judged by the doctor. The EBUS probe and GS are confirmed to reach the lesion by EBUS images.

Treatment:

Device: EBUS-GS