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

NCT ID: NCT07218042

Last Updated: 2025-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-02

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Mediastinal and Hilar Lymphadenopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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One EBUS Needle

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Patients underwent standard of care EBUS with two needles used.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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We 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role collaborator

Christopher Kapp

OTHER

Sponsor Role lead

Responsible Party

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Christopher Kapp

Assistant Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of California, Davis

Sacramento, California, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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STU00220729

Identifier Type: -

Identifier Source: org_study_id

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