ENB in the Diagnosis of Peripheral Pulmonary Nodules
Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedStudy Start
First participant enrolled
July 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedJuly 6, 2018
July 1, 2018
1.5 years
June 15, 2018
July 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
The difference of operation time between ENB-EBUS-GS group and EBUS-GS group
one week
The difference of complications between ENB-EBUS-GS group and EBUS-GS group
three months
Study Arms (2)
ENB-EBUS-GS group
EXPERIMENTALENB 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.
EBUS-GS group
ACTIVE COMPARATORENB 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.
Interventions
ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.
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).
Eligibility Criteria
You may qualify if:
- Patients who are older than 18 year-old.
- 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.
- Patients who agree to undergo bronchoscopy without any contraindications.
- Patients who have good compliance and sign informed consent.
You may not qualify if:
- Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
- Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
- Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Chest Hospitallead
- Air Force Military Medical University, Chinacollaborator
- Xiangya Hospital of Central South Universitycollaborator
Study Sites (1)
Shanghai Chest Hospital
Shanghai, 200030, China
Related Publications (6)
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: 24401166BACKGROUNDRivera 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.
PMID: 23649436BACKGROUNDSeijo 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.
PMID: 20435658BACKGROUNDLamprecht 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.
PMID: 22391437BACKGROUNDWang 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.
PMID: 21980059BACKGROUNDZheng X, Cao L, Zhang Y, Xie F, Yang H, Liu J, Qu S, Zhang J, Sun J. A Novel Electromagnetic Navigation Bronchoscopy System for the Diagnosis of Peripheral Pulmonary Nodules: A Randomized Clinical Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1730-1739. doi: 10.1513/AnnalsATS.202109-1071OC.
PMID: 35679184DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jiayuan Sun, MD,PhD
Shanghai Chest Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Endoscopy
Study Record Dates
First Submitted
June 15, 2018
First Posted
June 26, 2018
Study Start
July 4, 2018
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
July 6, 2018
Record last verified: 2018-07