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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Purge cleaning
Diagnostic testAdditional flushing of the needle into a separate vial
Treatment groups
Trial outcomes
Primary outcomes
Cytologic Contamination
To determine the presence of cytologic contamination following standard practice cleaning techniques
Secondary outcomes
Incidence of Pathological Upstaging
To evaluate the incidence of pathological upstaging based on our primary outcome findings
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.
Sponsors and contacts
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