ENB for the Diagnosis of PPNs:a Real World Study

Shanghai Chest Hospital479 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

479

Conditions

Peripheral Pulmonary Nodules

Interventions

Electromagnetic navigation bronchoscopy (ENB)PROCEDURE

ENB is carried out by a ENB system（LungCare, China) with/without other guided bronchoscopy techniques and/or ROSE, which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: 1. Presence of concomitant endobronchial lesion during the brochoscopy procerdure. 2. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Diagnostic yield

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.

Time frame: One year

Secondary Outcomes

The difference of diagnostic yield among groups of different methods of using ENB

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.

Time frame: One year

Factors affecting diagnostic yield

Factors affecting diagnostic yield including lesion size,bronchus sign, location and so on will be analyzed.

Time frame: One year

The difference of diagnostic yield among groups using different locatable guides

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.

Time frame: One year

Operation time

Operation time includes total operation time,total GS time and total EBUS time.

Time frame: One year

Incidence of complications

Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation.

Time frame: One year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.