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ENB for the Diagnosis of PPNs:a Real World Study

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ClinicalTrials.gov Identifier: NCT03716284
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
Fourth Military Medical University
Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Jiayuan Sun, Shanghai Chest Hospital

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.

Condition or disease Intervention/treatment
Peripheral Pulmonary Nodules Procedure: Electromagnetic navigation bronchoscopy (ENB)

Detailed Description:
The study will be conducted at no less than 5 clinical centers. Patients with peripheral pulmonary nodules suspicious for malignancy will be enrolled in the study. ENB will be performed with/without other guided bronchoscopy techniques and/or ROSE. Different biopsy methods will be recorded as well. The primary endpoint is the diagnostic yield of ENB. The secondary endpoints include factors affecting diagnostic yield, operation time, complications, safety and so on.

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules: a Real World Study
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Intervention Details:
  • Procedure: Electromagnetic navigation bronchoscopy (ENB)
    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.


Primary Outcome Measures :
  1. Diagnostic yield [ Time Frame: One year ]
    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.


Secondary Outcome Measures :
  1. The difference of diagnostic yield among groups of different methods of using ENB [ Time Frame: One year ]
    ENB will be performed with/without other guided bronchoscopy techniques and/or ROSE. Different biopsy methods will be recorded as well.The difference of diagnostic yield among groups of different methods of using ENB will be analyzed.

  2. Factors affecting diagnostic yield [ Time Frame: One year ]
    Factors affecting diagnostic yield including lesion size,bronchus sign, location and so on will be analyzed.

  3. The difference of diagnostic yield among groups using different locatable guides [ Time Frame: One year ]
    There are three kinds of locatable guides with different outer diameters. The difference of diagnostic yield among groups using different locatable guides will be analyzed.

  4. Operation time [ Time Frame: One year ]
    Operation time includes total operation time,total GS time and total EBUS time.

  5. Incidence of complications [ Time Frame: One year ]
    Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who meet inclusion/exclusion criteria will be enrolled in the study consecutively in each clinical center.
Criteria

Inclusion Criteria:

  1. Patients who are older than 18 year-old.
  2. 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.
  3. Patients who agree to undergo bronchoscopy without any contraindications.
  4. Patients who have good compliance and sign informed consent.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716284


Contacts
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Contact: Jiayuan Sun, MD,PhD 86-21-22200000 ext 1511 jysun1976@163.com

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Jiayuan Sun, PhD    86-021-22200000 ext 1511    jysun1976@163.com   
Sponsors and Collaborators
Shanghai Chest Hospital
Fourth Military Medical University
Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Jiayuan Sun, MD,PhD Shanghai Chest Hospital

Publications:
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Responsible Party: Jiayuan Sun, Director, Department of Endoscopy, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT03716284    
Other Study ID Numbers: 2017YFC0112701-2
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiayuan Sun, Shanghai Chest Hospital:
electromagnetic navigation bronchoscopy(ENB)
peripheral pulmonary nodules
diagnostic yield
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases