Evaluation of Endobronchial Ultrasound Needle Cleaning Techniques and Their Impact on Specimen Contamination

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Mississippi Medical Center

About this trial

Endobronchial ultrasound (EBUS) bronchoscopy is commonly used to sample lymph nodes in patients with suspected or known lung cancer to determine the stage of the disease. Accurate staging is essential as it directly impacts treatment decisions and prognosis. During EBUS procedures, needles are often reused across multiple lymph node stations and are typically flushed with saline between samples. This raises the concern that residual tumor cells may contaminate the samples and could potentially incorrectly upstage disease.

This prospective study will evaluate the current technique used during EBUS procedures to determine if more intensive cleaning leads to reduced cellular contamination without affecting diagnostics. Patients undergoing an EBUS procedure for diagnosis with a large mass and a high probability of malignancy will be selected for the study. Rapid On-Site Examination (ROSE) will be used at the bedside to determine the presence of abnormal cells. Following the final pass, before moving to the next station, the needle will be flushed with saline as normal and then flushed again into another container to evaluate the presence of residual cells. The outcome may help EBUS needle handling practices and improve lung cancer staging accuracy.

No additional invasive procedures are performed as part of this study; all analyses utilize material obtained during routine EBUS needle flushing, with no added needle sticks or alteration of clinical care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older

Patients undergoing standard-of-care EBUS bronchoscopy for evaluation of suspected lung malignancy

Patients undergoing sampling of 2 or more lymph node stations during EBUS bronchoscopy

Ability to provide informed consent

Disqualifiers

Age less than 18

Recent (1 month or less) radiation or procedural manipulation of lymph node stations that may significantly change lymph node architecture

Trial design

Design model

Parallel

Treatments tested in this trial

  • Purge cleaning

    Diagnostic test

    Additional flushing of the needle into a separate vial

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Purge cleaningExperimental treatment 1 intervention
Group B: Standard practiceNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Cytologic Contamination

To determine the presence of cytologic contamination following standard practice cleaning techniques

Time frame
From enrollment to the date of the pathological review report of the specimen taken during diagnostic EBUS sampling for a period of up to 32 weeks post enrollment and randomization in trial for each patient enrolled.

Secondary outcomes

1

Incidence of Pathological Upstaging

To evaluate the incidence of pathological upstaging based on our primary outcome findings

Time frame
From enrollment to the date of the pathological review report of the specimen taken during diagnostic EBUS sampling for a period of up to 32 weeks post enrollment and randomization in trial for each patient enrolled.
2

Effectiveness of Additional Flushing

To establish whether enhanced flushing protocols are required to mitigate the risk of contamination as evidenced by a change in incidences of cytologic contamination as reported by pathologic assessment of specimens taken after enhanced cleaning techniques.

Time frame
From enrollment to the date of the pathological review report of the specimen taken during diagnostic EBUS sampling for a period of up to 32 weeks post enrollment and randomization in trial for each patient enrolled.

Other outcomes

Sponsors and contacts

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