ENB in the Diagnosis of Peripheral Pulmonary Nodules

Not Applicable

• Conditions: Peripheral Pulmonary Nodules
• Interventions: Device: ENB; Device: EBUS-GS

• Registration Number: NCT03569306
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-26
• Status Verified: 2018-07
• Study Start: 2018-07-04
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-07-06
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ENB-EBUS-GS group	ENB	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.
ENB-EBUS-GS group	EBUS-GS	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.
EBUS-GS group	EBUS-GS	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.

Primary Outcome Measures

Name	Time	Method
The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group	one year	Diagnostic yield is defined as proportion of true positive and true negative.

Secondary Outcome Measures

Name	Time	Method
The difference of operation time between ENB-EBUS-GS group and EBUS-GS group	one week	The operation time includes total operation time,total GS time and total EBUS time
The difference of complications between ENB-EBUS-GS group and EBUS-GS group	three months	Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China