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| Name | Class |
|---|---|
| Air Force Military Medical University, China | OTHER |
| Xiangya Hospital of Central South University | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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Patients who meet inclusion/exclusion criteria will be enrolled in the study consecutively in each clinical center.
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| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun, MD,PhD | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28399830 | Background | 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. | |
| 26367186 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 21, 2023 | |
| Reset | Mar 29, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 21, 2023 | Mar 29, 2024 |
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| Factors affecting diagnostic yield |
Factors affecting diagnostic yield including lesion size,bronchus sign, location and so on will be analyzed. |
| 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. | One year |
| Operation time | Operation time includes total operation time,total GS time and total EBUS time. | One year |
| Incidence of complications | Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation. | One year |
| Background |
| 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. |
| 27113209 | Background | 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. |
| 24401166 | Background | 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. |
| 37734951 | Derived | Li Y, Chen W, Xie F, Huang R, Liu X, Xiao Y, Cao L, Hu Y, Ke M, Wu S, Sun J. Novel electromagnetic navigation bronchoscopy system for the diagnosis of peripheral pulmonary nodules: a prospective, multicentre study. Thorax. 2023 Dec;78(12):1197-1205. doi: 10.1136/thorax-2022-219664. Epub 2023 Sep 21. |
| 33209616 | Derived | 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. |