ENB for the Diagnosis of PPNs:a Real World Study

Completed

• Conditions: Peripheral Pulmonary Nodules

• Registration Number: NCT03716284
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

The study is designed as a multi-center prospective trial of ENB for the diagnosis of peripheral pulmonary nodules in the real world. The purpose of the study is to identify the optimal method of using ENB.

Detailed Description

The study will be conducted at no less than 5 clinical centers. Patients with peripheral pulmonary nodules suspicious for malignancy will be enrolled in the study. ENB will be performed with/without other guided bronchoscopy techniques and/or ROSE. Different biopsy methods will be recorded as well. The primary endpoint is the diagnostic yield of ENB. The secondary endpoints include factors affecting diagnostic yield, operation time, complications, safety and so on.

Study Timeline

• Study First Submitted: 2018-10-20
• Study First Submitted QC: 2018-10-20
• Study First Posted: 2018-10-23
• Study Start: 2019-03-20
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 479

Inclusion Criteria

1. Patients who are older than 18 year-old.
2. Chest CT shows peripheral pulmonary nodule (8mm<longest diameter≤30mm) suspicious for malignant that needs to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible with 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. Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
2. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	One year	Diagnostic yield is defined as proportion of true positive and true negative. The primary endpoint is diagnostic yield of ENB with/without other guided bronchoscopy techniques or ROSE.

Secondary Outcome Measures

Name	Time	Method
The difference of diagnostic yield among groups of different methods of using ENB	One year	ENB will be performed with/without other guided bronchoscopy techniques and/or ROSE. Different biopsy methods will be recorded as well.The difference of diagnostic yield among groups of different methods of using ENB will be analyzed.
Incidence of complications	One year	Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation.
Factors affecting diagnostic yield	One year	Factors affecting diagnostic yield including lesion size,bronchus sign, location and so on will be analyzed.
The difference of diagnostic yield among groups using different locatable guides	One year	There are three kinds of locatable guides with different outer diameters. The difference of diagnostic yield among groups using different locatable guides will be analyzed.
Operation time	One year	Operation time includes total operation time,total GS time and total EBUS time.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China