Lung Cancer (Locally Advanced or Metastatic)
Conditions
Keywords
Lung Cancer, Endobronchial ultrasound (EBUS) bronchoscopy, Cytologic Contamination, Cancer Staging
Brief 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.
Interventions
DIAGNOSTIC_TESTPurge cleaning
Additional flushing of the needle into a separate vial
Sponsors
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A prospective study conducted in patients undergoing an EBUS procedure for lung cancer diagnosis. Selected patients will undergo a two-step process following the final pass of a station verified to have abnormal cells by ROSE. The EBUS needle will undergo cleaning as follows: 1. Standard practice - standard saline flush following lesion sampling 2. Purge cleaning - additional flushing of the needle into a separate vial Samples will then be sent to pathology as normal for evaluation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Age less than 18 * Recent (1 month or less) radiation or procedural manipulation of lymph node stations that may significantly change lymph node architecture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cytologic Contamination | 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. | To determine the presence of cytologic contamination following standard practice cleaning techniques |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Pathological Upstaging | 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. | To evaluate the incidence of pathological upstaging based on our primary outcome findings |
| Effectiveness of Additional Flushing | 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. | 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. |
Countries
United States
Contacts
CONTACTYanglin Guo, MD
CONTACTRicardo Ungo, MD
PRINCIPAL_INVESTIGATORYanglin Guo, MD
University of Mississippi Medical Center
Outcome results
None listed