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 (SPEED NEEDLE)

Christopher Kapp

Status: Active, not recruiting

Conditions: Mediastinal and Hilar Lymphadenopathy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07218042

STU00220729

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups

One EBUS Needle

Active Comparator group

Description:

Patients underwent a standard of care EBUS with one needle utilized in the procedure.

Treatment:

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

Two EBUS Needle

Experimental group

Description:

Patients underwent standard of care EBUS with two needles used.

Treatment:

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