An interventional study of Purge cleaning in Lung Cancer (Locally Advanced or Metastatic), sponsored by University of Mississippi Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by University of Mississippi Medical Center · Not applicable, Interventional, and Diagnostic
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.
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.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 204 is above the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of Mississippi Medical Center is the lead sponsor of 129 studies on the registry; 20 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Additional flushing of the needle into a separate vial.
Diagnostic Test: Purge cleaning
Standard saline flush following lesion sampling
Additional flushing of the needle into a separate vial
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.
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.
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.
Plan to share: Yes — Individual participant data, such as age and gender, that are utilized in results for publication will be shared.
Start is estimated for Apr 2026; primary completion for May 2027, 13 months later.
Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's planned 13 months is below that.
Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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