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Completed

NCT Number: NCT01863836

Study on the Influence of Fluoroscopy in the Diagnosis of Peripheral Lung Lesions With Endobronchial Ultrasound Guidance

The purpose of this study is to determine whether the use of fluoroscopy improves the diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial ultrasound (with the use of a guide sheath).

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Key information

Conditions

Peripheral Pulmonary Lesions Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval

Québec, Quebec, G1V 4G5, Canada

About this study

See above

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Consecutive patients referred for the bronchoscopic diagnosis of peripheral pulmonary lesions at the Institut Universitaire de Cardiologie et de Pneumologie de Québec(not visible endobronchially)
  • Adults over the age of 18

Exclusion criteria

  • Therapeutic anticoagulation
  • Antiplatelet therapy other than aspirin
  • Known hemorrhagic diathesis
  • Acute respiratory failure
  • Pregnancy
  • Inability to provide informed consent

Treatment and study plan

Fluoroscopy

Procedure

Radial EBUS-guided biopsy

Procedure

Primary outcomes

  1. Diagnostic yield

    Time frame: Upon production of pathology results, usually within 2 weeks after the test

    Diagnostic yield of radial endobronchial ultrasound-guided biopsy for peripheral lung lesions defined as the proportion of patients in whom a specific diagnosis is established by radial endobronchial ultrasound-guided biopsy. The analysis will be stratified by lesion size, location, the presence of the bronchus sign, type of echographic image obtained (central/peripheral), physician involved, resident involvement.

  2. Sensitivity and specificity

    Time frame: Upon completion of ancillary or confirmatory tests, usually within 2 months after the test

    Sensitivity and specificity are determined separately for malignancy and benign etiologies. Case records will be reviewed for patients with non-diagnostic specimen and results from other diagnostic procedures (TTNA, surgical biopsy) will be reviewed. For patients without further diagnostic tests, stability or progression of the lesion over time will be used for etiology attribution.

Secondary outcomes

  1. Lesion localization

    Time frame: Immediate (during the test)

    Proportion of patients in whom the peripheral pulmonary lesion was localized using the radial endobronchial ultrasound.

  2. Procedure duration

    Time frame: During the test

    Total duration of the bronchoscopic test.

  3. Complications

    Time frame: Immediately during the test and up to 4 hours after the test

    occurrence of pneumothorax (and its management), bleeding more than 50ml, sustained desaturation below 90%, cardiac dysrhythmias, or any other adverse events occuring during or after the procedure.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Randomized Trial of Fluoroscopy Use for Radial Endobronchial Ultrasound-guided Biopsy of Peripheral Lung Lesions

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 29, 2013
Registry last updated
Sep 20, 2016

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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