ENB in the Diagnosis of Peripheral Pulmonary Nodules

Peripheral Pulmonary Nodules Clinical Trial

Official title:

Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03569306
• Other study ID #: 2017YFC0112701-1
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: July 2018
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun, MD,PhD
• Phone: 86-21-22200000
• Email: jysun1976[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.

Description:

The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• 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) suspected to be malignant that need to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible in 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. Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.

2. Presence of concomitant endobronchial lesion during the brochoscopy procerdure.

3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Peripheral Pulmonary Nodules

Intervention

Device:
• ENB
ENB is carried out by a ENB system(LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.
• EBUS-GS
EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	Fourth Military Medical University, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (5)

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

Lamprecht B, Porsch P, Wegleitner B, Strasser G, Kaiser B, Studnicka M. Electromagnetic navigation bronchoscopy (ENB): Increasing diagnostic yield. Respir Med. 2012 May;106(5):710-5. doi: 10.1016/j.rmed.2012.02.002. Epub 2012 Mar 3. — View Citation

Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e142S-e165S. doi: 10.1378/chest.12-2353. — View Citation

Seijo LM, de Torres JP, Lozano MD, Bastarrika G, Alcaide AB, Lacunza MM, Zulueta JJ. Diagnostic yield of electromagnetic navigation bronchoscopy is highly dependent on the presence of a Bronchus sign on CT imaging: results from a prospective study. Chest. 2010 Dec;138(6):1316-21. doi: 10.1378/chest.09-2708. Epub 2010 Apr 30. — View Citation

Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group	Diagnostic yield is defined as proportion of true positive and true negative.	one year
Secondary	The difference of operation time between ENB-EBUS-GS group and EBUS-GS group	The operation time includes total operation time,total GS time and total EBUS time	one week
Secondary	The difference of complications between ENB-EBUS-GS group and EBUS-GS group	Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation	three months