NCT03004586

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2020

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 22, 2022

Completed
Last Updated

June 22, 2022

Status Verified

May 1, 2022

Enrollment Period

3.5 years

First QC Date

December 19, 2016

Results QC Date

June 22, 2021

Last Update Submit

May 25, 2022

Conditions

Malignant Neoplasm of Respiratory and Intrathoracic Organ CarcinomaLung Cancer

Keywords

Malignant Neoplasm of Respiratory and Intrathoracic Organ CarcinomaLung cancerUltrasound-guided transbronchial needle aspirationEBUS-TBNA25-gauge needle22-gauge needle

Outcome Measures

Primary Outcomes (1)

  • Percentage of Lymph Nodes With Adequate Samples

    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.

    One to two hours.

Secondary Outcomes (2)

  • Concordance With the Final Diagnosis

    One to two hours

  • Usability of the Needle

    1-2 hours (Intra procedurally)

Study Arms (2)

EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle

EXPERIMENTAL

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle.

Device: 25-Gauge NeedleDevice: 22-Gauge NeedleProcedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)

EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle

EXPERIMENTAL

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle.

Device: 25-Gauge NeedleDevice: 22-Gauge NeedleProcedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)

Interventions

25-Gauge NeedleDEVICE

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

EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge NeedleEBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle
22-Gauge NeedleDEVICE

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

EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge NeedleEBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle
Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)PROCEDURE

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

Also known as: EBUS-TBNA
EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge NeedleEBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
George Eapen,MD/ Professor, Pulmonary Medicine
Organization
UT MD Anderson Cancer Center
geapen@mdanderson.org
(713) 563-4256

Study Officials

  • George A. Eapen, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 29, 2016

Study Start

December 16, 2016

Primary Completion

June 25, 2020

Study Completion

June 25, 2020

Last Updated

June 22, 2022

Results First Posted

June 22, 2022

Record last verified: 2022-05

Locations

US(1)