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NCT Number: NCT03004586

Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle

The goal of this clinical research study is to compare the effectiveness of a smaller, 25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) instead of a standard 22-gauge needle.

The safety of the needles will also be studied.

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Key information

Conditions

Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma 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

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

As a part of participant's standard-of-care, participant will have a bronchoscopy of lesions on participant's lung nodules and/or lymph nodes before the EBUS-TBNA. Participant will sign a separate consent for the bronchoscopy.

If participant agrees to take part in this study, before participant's bronchoscopy, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

  • If participant is in Group 1, participant will have the EBUS-TBNA performed by first using a 25-gauge needle, followed by a 22-gauge needle.
  • If participant is in Group 2, participant will have the EBUS-TBNA performed by first using a 22-gauge needle, followed by a 25-gauge needle.

To perform an EBUS-TBNA, a needle is inserted into the affected area using ultrasound imaging to collect tissue from the lungs and lymph nodes. The doctor will use the imaging to guide the needle into the area.

Length of Study:

Participation on the study will be over after the bronchoscopy and EBUS-TBNA.

This is an investigational study. The 22-gauge and 25-gauge needles are FDA approved for use in EBUS-TBNAs. The comparison of the 2 needles for this procedure is investigational. The study doctor can explain how the needles are designed to work.

Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • Indication for EBUS-guided needle biopsy based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes.

Exclusion criteria

  • Patients who are pregnant or lactating
  • Inability to give informed consent
  • Patients in which only one lymph node station is expected to be sampled by the performing clinician.

Treatment and study plan

25-Gauge Needle

Device

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.

22-Gauge Needle

Device

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.

Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)

Procedure

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed.

Other names: EBUS-TBNA

Primary outcomes

  1. Percentage of Lymph Nodes With Adequate Samples

    Time frame: One to two hours.

    The primary outcome was the proportion of concordance between the 22-gauge and 25-gauge needles in sample adequacy after two passes. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. Sample adequacy was assessed after 2 passes using each needle in all participants and recorded.

Secondary outcomes

  1. Concordance With the Final Diagnosis

    Time frame: One to two hours

    The difference in the diagnostic yield between the 22-gauge and 25-gauge needles in terms of degree of concordance with the final diagnosis. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The percentage of concordance was calculated by comparing the 2 passes from each needle to the final diagnosis.

  2. Usability of the Needle

    Time frame: 1-2 hours (Intra procedurally)

    The difference in usability between the 22-gauge and 25-gauge needles. All participant's lymph nodes were sampled by two 25-gauge needles and two 22-gauge needles for a total of 4 needles per person. Measured by a Likert scale 1-5 with 1 being the lowest and 5 being the maximum score. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The participants are reported per intervention.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle; A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 29, 2016
Registry last updated
Jun 22, 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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