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Completed

NCT Number: NCT01741571

Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) techniques have not been well studied. The investigators will conduct a randomized study comparing the diagnostic yield and specimen quality of EBUS-FNA performed with and without suction applied.

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Key information

Conditions

Lung Cancer 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

American University of Beirut

Beirut, Lebanon

About this study

Consecutive patients with suspected malignant peribronchial masses or lymph nodes undergoing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) will be enrolled. All participants will have 4 needle aspirations of each targeted peribronchial lesion. Two needle aspirations will be performed while applying suction and 2 needle aspirations will be performed without applying suction in random order. The investigators will compare the diagnostic yield and the quality of the specimens obtained using the two techniques.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult undergoing EBUS at AUBMC for suspected malignancy

Exclusion criteria

  • Coagulopathy
  • The lesion cannot be sampled because of intervening tumor or blood vessels.

Treatment and study plan

EBUS guided FNA with and without suction

Device

Device/procedure: lymph node tissue collection using needle with and without suction applied.

Four fine needle aspirations will be taken from each lymph node. Two with suction and two without suction applied.

Primary outcomes

  1. Sensitivity of each needle aspiration technique for diagnosis of malignancy

    Time frame: Diagnosis of malignancy will be ascertained after 6 month clinical follow up

    A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells.

    The sensitivity for diagnosing malignancy will be calculated and compared for the two needle aspiration technique.

  2. Diagnostic accuracy of each needle aspiration technique for diagnosis of malignancy

    Time frame: Diagnosis of malignancy will be ascertained after 6 month clinical follow up

    A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells.

    The diagnostic accuracy for diagnosing malignancy will be assessed and compared for the two needle aspiration technique.

Secondary outcomes

  1. Adequacy of the needle aspiration sample

    Time frame: Adequacy will be assessed within 1 week from procedure

    A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for adequacy (presence of malignant cells, granuloma or lymphocytes) The number of adequate samples will be compared for the two techniques.

  2. Negative predicted value of each needle aspiration technique for diagnosis of malignancy

    Time frame: Diagnosis of malignancy will be ascertained after 6 month of clinical follow up

    A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells.

    The negative predictive value for lack of malignant cells will be calculated and compared for the two needle aspiration techniques.

  3. Specificity of each needle aspiration technique for diagnosis of malignancy

    Time frame: Diagnosis of malignancy will be ascertained after 6 month clinical follow up

    A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells.

    The specificity for diagnosing malignant cells will be calculated and compared for the two needle aspiration techniques.

  4. Positive predicted value of each needle aspiration technique for diagnosis of malignancy

    Time frame: Diagnosis of Malignancy will be ascertained after 6 month of clinical follow up

    A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells.

    The positive predictive value for presence of malignant cells will be calculated and compared for the two needle aspiration techniques.

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Dec 5, 2012
Registry last updated
Sep 21, 2020

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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