ENB in the Diagnosis of Peripheral Pulmonary Nodules

• Sponsor: Shanghai Chest Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03569306
• Collaborator: Air Force Military Medical University, China (Other), Xiangya Hospital of Central South University (Other)
• Enrollment: 400
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.9
• Patients Per Site Per Month: 22.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Pulmonary Nodules	Device: ENB; Device: EBUS-GS	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules
• Actual Study Start Date: Jul 4, 2018
• Anticipated Primary Completion Date: Dec 30, 2019
• Anticipated Study Completion Date: Dec 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ENB-EBUS-GS group ENB is used in this group.EBUS and GS are inserted into bronchi in the assistance of ENB. The EBUS probe and GS are confirmed to reach the lesion by EBUS images.	Device: ENB; ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.; Device: 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).
Active Comparator: EBUS-GS group ENB isn't used in this group.EBUS and GS are inserted into bronchi according to the chest CT that judged by the doctor. The EBUS probe and GS are confirmed to reach the lesion by EBUS images.	Device: 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).

Outcome Measures

Primary Outcome Measures

1. The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group [one year]

   Diagnostic yield is defined as proportion of true positive and true negative.

Secondary Outcome Measures

1. The difference of operation time between ENB-EBUS-GS group and EBUS-GS group [one week]

   The operation time includes total operation time,total GS time and total EBUS time

2. The difference of complications between ENB-EBUS-GS group and EBUS-GS group [three months]

   Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Chest Hospital	Shanghai		China	200030

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Jiayuan Sun, MD,PhD, Shanghai Chest Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Jiayuan Sun, Director, Department of Endoscopy, Shanghai Chest Hospital
• ClinicalTrials.gov Identifier: NCT03569306
• Other Study ID Numbers: 2017YFC0112701-1
• First Posted: Jun 26, 2018
• Last Update Posted: Jul 6, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jiayuan Sun, Director, Department of Endoscopy, Shanghai Chest Hospital: Electromagnetic navigation bronchoscopy(ENB); peripheral pulmonary nodules; diagnostic yield
• Additional relevant MeSH terms: Multiple Pulmonary Nodules

Study Results

No Results Posted as of Jul 6, 2018