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Completed

NCT Number: NCT03716284

ENB for the Diagnosis of PPNs:a Real World Study

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.

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Key information

Conditions

Peripheral Pulmonary Nodules

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Electromagnetic navigation bronchoscopy (ENB)

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Collaborators

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

Registry information

Official study title

Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules: a Real World Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2018
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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