NCT07461662

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

EBUS guided transbronchial needle aspiration (TBNA) is a cornerstone in lung cancer staging. Accurate nodal staging under the TNM 9th edition guidelines is essential. Prior work has demonstrated that EBUS needle contamination can occur. A prospective multicenter study published in Archivos de Bronconeumologia demonstrates residual malignant cells despite repeated saline flushes with increasing flush volumes. A prospective observational study by Berim et al. showed malignant and non-malignant cellular debris can persist after multiple cleaning steps. Repeated flushing reduced but did not eliminate the contaminants, suggesting the current practice of flushing with saline may be insufficient to prevent contamination. The above studies demonstrate that contamination does exist in EBUS needle aspiration though there is no universal consensus on how to address contamination risk. The proposed project would identify cytologic contamination present in our current practices, without any additional risk from a procedural standpoint to the patient. This project would also examine the presence of malignant cells despite additional flushing.

Conditions

• Lung Cancer (Locally Advanced or Metastatic)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Purge cleaning	Additional flushing of the needle into a separate vial

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-05-31
• Completion: 2027-08-31
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study