ENB for the Diagnosis of PPNs:a Real World Study

Peripheral Pulmonary Nodules Clinical Trial

Official title:

Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules: a Real World Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716284
• Other study ID #: 2017YFC0112701-2
• Status: Completed
• Start date: March 20, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Peripheral Pulmonary Nodules

Intervention

Procedure:
• Electromagnetic navigation bronchoscopy (ENB)
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.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	Air Force Military Medical University, China, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (4)

Folch EE, Bowling MR, Gildea TR, Hood KL, Murgu SD, Toloza EM, Wahidi MM, Williams T, Khandhar SJ. Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy. BMC Pulm Med. 2016 Apr 26;16(1):60. doi: 10.1186/s12890-016-0228-y. Review. — View Citation

Gex G, Pralong JA, Combescure C, Seijo L, Rochat T, Soccal PM. Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis. Respiration. 2014;87(2):165-76. doi: 10.1159/000355710. Epub 2014 Jan 3. Review. — View Citation

Khandhar SJ, Bowling MR, Flandes J, Gildea TR, Hood KL, Krimsky WS, Minnich DJ, Murgu SD, Pritchett M, Toloza EM, Wahidi MM, Wolvers JJ, Folch EE; NAVIGATE Study Investigators. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med. 2017 Apr 11;17(1):59. doi: 10.1186/s12890-017-0403-9. — View Citation

Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J, Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D, Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR, Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry. Am J Respir Crit Care Med. 2016 Jan 1;193(1):68-77. doi: 10.1164/rccm.201507-1332OC. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year
Secondary	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.	One year
Secondary	Factors affecting diagnostic yield	Factors affecting diagnostic yield including lesion size,bronchus sign, location and so on will be analyzed.	One year
Secondary	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.	One year
Secondary	Operation time	Operation time includes total operation time,total GS time and total EBUS time.	One year
Secondary	Incidence of complications	Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation.	One year