ENB for the Diagnosis of PPNs:a Real World Study

NCT03716284 | Completed DMC

• 1 other identifier: 2017YFC0112701-2
• Study Type: observational
• Target: 479
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Pulmonary Nodules

Keywords

electromagnetic navigation bronchoscopy(ENB); peripheral pulmonary nodules; diagnostic yield

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  One year

• Factors affecting diagnostic yield

  One year

• The difference of diagnostic yield among groups using different locatable guides

  One year

• Operation time

  One year

• Incidence of complications

  One year

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who meet inclusion/exclusion criteria will be enrolled in the study consecutively in each clinical center.

You may qualify if:

• Patients who are older than 18 year-old.
• 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.
• Patients who agree to undergo bronchoscopy without any contraindications.
• Patients who have good compliance and sign informed consent.

You may not qualify if:

• Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
• Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Air Force Military Medical University, China: collaborator
• Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (6)

• 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.

  PMID: 28399830 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.

  PMID: 26367186 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.

  PMID: 27113209 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.

  PMID: 24401166 BACKGROUND

• 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.

  PMID: 37734951 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.

  PMID: 33209616 DERIVED

Study Officials

• Jiayuan Sun, MD,PhD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Endoscopy

Study Record Dates

• First Submitted: October 20, 2018
• First Posted: October 23, 2018
• Study Start: March 20, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

CN (1)