Back to resultsENB in the Diagnosis of Peripheral Pulmonary Nodules
Primary Purpose
Peripheral Pulmonary Nodules
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ENB
EBUS-GS
Sponsored by
About this trial
This is an interventional diagnostic trial for Peripheral Pulmonary Nodules focused on measuring Electromagnetic navigation bronchoscopy(ENB), peripheral pulmonary nodules, diagnostic yield
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Shanghai Chest HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ENB-EBUS-GS group
EBUS-GS group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT03569306
First Posted
June 15, 2018
Last Updated
July 4, 2018
Sponsor
Shanghai Chest Hospital
Collaborators
Air Force Military Medical University, China, Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT03569306
Brief Title
ENB in the Diagnosis of Peripheral Pulmonary Nodules
Official Title
Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 4, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
Collaborators
Air Force Military Medical University, China, Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Pulmonary Nodules
Keywords
Electromagnetic navigation bronchoscopy(ENB), peripheral pulmonary nodules, diagnostic yield
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ENB-EBUS-GS group
Arm Type
Experimental
Arm Description
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.
Arm Title
EBUS-GS group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ENB
Intervention Description
ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.
Intervention Type
Device
Intervention Name(s)
EBUS-GS
Intervention Description
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).
Primary Outcome Measure Information:
Title
The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group
Description
Diagnostic yield is defined as proportion of true positive and true negative.
Time Frame
one year
Secondary Outcome Measure Information:
Title
The difference of operation time between ENB-EBUS-GS group and EBUS-GS group
Description
The operation time includes total operation time,total GS time and total EBUS time
Time Frame
one week
Title
The difference of complications between ENB-EBUS-GS group and EBUS-GS group
Description
Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayuan Sun, MD,PhD
Phone
86-21-22200000
Ext
1511
Email
jysun1976@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD,PhD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD,PhD
Phone
18017321598
Email
jysun1976@163.com
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
24401166
Citation
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.
Results Reference
background
PubMed Identifier
23649436
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.
Results Reference
background
PubMed Identifier
20435658
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.
Results Reference
background
PubMed Identifier
22391437
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.
Results Reference
background
PubMed Identifier
21980059
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.
Results Reference
background
PubMed Identifier
35679184
Citation
Zheng 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.
Results Reference
derived
Learn more about this trial
ENB in the Diagnosis of Peripheral Pulmonary Nodules
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