Clinical trial NCT03716284: ENB for the Diagnosis of PPNs:a Real World Study
Official title: Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules: a Real World Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Pulmonary Nodules
Keywords: electromagnetic navigation bronchoscopy(ENB)
peripheral pulmonary nodules
diagnostic yield
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
name: Xiangya Hospital of Central South University
First posted: 2018-10-23
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who meet inclusion/exclusion criteria will be enrolled in the study consecutively in each clinical center.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic yield
timeFrame: One year
Secondary outcomes:
measure: The difference of diagnostic yield among groups of different methods of using ENB
timeFrame: One year
measure: Factors affecting diagnostic yield
timeFrame: One year
measure: The difference of diagnostic yield among groups using different locatable guides
timeFrame: One year
measure: Operation time
timeFrame: One year
measure: Incidence of complications
timeFrame: One year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
citation: Jiang S, Liu X, Chen J, Ma H, Xie F, Sun J. A pilot study of the ultrathin cryoprobe in the diagnosis of peripheral pulmonary ground-glass opacity lesions. Transl Lung Cancer Res. 2020 Oct;9(5):1963-1973. doi: 10.21037/tlcr-20-957.