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Study of Procedural Efficiency in EBUS With Dual Versus Single NEEDLEs: Evaluating the Value of a Second Needle in EBUS as it Pertains to Economic and Environmental Impact

Are Two Needles Really Better Than One? A Time, Economic, and Environmental Evaluation of EBUS-TBNA

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07218042
Acronym
SPEED NEEDLE
Enrollment
126
Registered
2025-10-17
Start date
2024-02-02
Completion date
2025-12-31
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mediastinal and Hilar Lymphadenopathy

Keywords

Bronchoscopy, EBUS

Brief summary

Currently, the EBUS bronchoscopy procedure uses either one or two needles to perform the biopsy of the lymph node based on physician preference. We want to determine the optimal number of needles to use for future EBUS bronchoscopy procedures like the one you are scheduled to have for your care and investigate the economic and environmental impact and time involved in using one versus two needles.

Detailed description

Endobronchial Ultrasound (EBUS) is a mainstay of diagnostic bronchoscopy, as it is performed for mediastinal and hilar lymph node sampling for cancer staging, diagnosis of sarcoidosis, lymphoma, infection, and other disease processes. It is a procedure that is commonplace in all bronchoscopy suites across the world. In our bronchoscopy suite, our current practice varies based on the bronchoscopist and number of lymph nodes requiring sampling in a procedure (can range from 1-5) as to whether one or two needles are utilized. The bronchoscopist may use two needles to save time when multiple lymph nodes must be biopsied or if an individual node needs to be biopsied several times to obtain more tissue for pathologic study. EBUS needles are single use and there is one randomized trial (n=20 patients) that showed a decreased time of procedure in patients where two needles were used versus one (Khan et al., 2013). However, no data exist evaluating the economic impact (cost of needle versus endoscopy dollars saved) or environmental impact of using one versus two needles. This study will examine these factors to determine the optimal way to perform this procedure in the future, considering the procedure and anesthesia time, economic costs, and environmental costs.

Interventions

DIAGNOSTIC_TESTWe randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.

We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.

Sponsors

Duke University
CollaboratorOTHER
University of California, Davis
CollaboratorOTHER
Christopher Kapp
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Undergoing a bronchoscopy with lymph node sampling

Exclusion criteria

* Unable to get a bronchoscopy procedure for various reasons * Other criteria per protocol uploaded

Design outcomes

Primary

MeasureTime frame
Time Under AnesthesiaDuring bronchoscopy procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026