Lung Cancer (Locally Advanced or Metastatic)EBUSNCT07461662
Evaluation of Endobronchial Ultrasound Needle Cleaning Techniques and Their Impact on Specimen Contamination
A study testing Purge cleaning in people with Lung Cancer (Locally Advanced or Metastatic), run by University of Mississippi Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Locally Advanced or Metastatic)
- What is being tested?
- Purge cleaning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Yanglin Guo, MD, 6019845650, yguo@umc.edu
Ricardo Ungo, MD, 6019845660, rungo@umc.edu
About this study
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.
Read the 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.
- Being tested
- Purge cleaning
- Keywords
- Lung Cancer, Endobronchial ultrasound (EBUS) bronchoscopy, Cytologic Contamination, Cancer Staging
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purge cleaningDiagnostic test
Additional flushing of the needle into a separate vial
| Study group | Role | What they receive |
|---|---|---|
| Purge cleaning | Experimental | Additional flushing of the needle into a separate vial. Receives: Diagnostic Test: Purge cleaning |
| Standard practice | No intervention | Standard saline flush following lesion sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytologic Contamination
To determine the presence of cytologic contamination following standard practice cleaning techniques
Measured: 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 (2)
Incidence of Pathological Upstaging
To evaluate the incidence of pathological upstaging based on our primary outcome findings
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (Locally Advanced or Metastatic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Guo, University of Mississippi Medical Center
- Investigators
- Yanglin Guo, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461662
- Sponsor's protocol ID
- UMMC-IRB-2026-37
- Acronym
- EBUS
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data, such as age and gender, that are utilized in results for publication will be shared.
Publications
Berim IG, Colanta A, Saeed AI, et al. Contamination of Needles Used for Endobronchial Ultrasound Guided Biopsies: Myth Confirmed. American Journal of Respiratory and Critical Care Medicine 2017;195:A2868
Tirapu Puyal JM, Mugica Atorrasagasti N, Leal Arranz MV, Santana Astudillo JC, Lopez Duque JC, Ortega Comunian L, Rezola Bajineta M, Segues Merino N. Cytologic Contamination of the Sampling Needle in Endobronchial Ultrasound. Arch Bronconeumol. 2022 Apr;58(4):367-368. doi: 10.1016/j.arbres.2021.07.011. Epub 2021 Aug 24. No abstract available. English, Spanish.
PubMed 35312544
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endobronchial Ultrasound Needle Cleaning Techniques and Their Impact on Specimen Contamination
- ClinicalTrials.gov ID
- NCT07461662
- Acronym / sponsor ID
- EBUS / UMMC-IRB-2026-37
- Keywords
- Lung Cancer, Endobronchial ultrasound (EBUS) bronchoscopy, Cytologic Contamination, Cancer Staging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Purge cleaning | Experimental | Diagnostic Test: Purge cleaningAdditional flushing of the needle into a separate vial. |
| Standard practice | No intervention | –Standard saline flush following lesion sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Age less than 18
- Recent (1 month or less) radiation or procedural manipulation of lymph node stations that may significantly change lymph node architecture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Purge cleaningAdditional flushing of the needle into a separate vial | Diagnostic test | Purge cleaning |
Primary outcome
Cytologic Contamination
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.
To determine the presence of cytologic contamination following standard practice cleaning techniques
2 secondary outcomes
Incidence of Pathological Upstaging
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- BackgroundBerim IG, Colanta A, Saeed AI, et al. Contamination of Needles Used for Endobronchial Ultrasound Guided Biopsies: Myth Confirmed. American Journal of Respiratory and Critical Care Medicine 2017;195:A2868
- Background: PubMed 35312544Tirapu Puyal JM, Mugica Atorrasagasti N, Leal Arranz MV, Santana Astudillo JC, Lopez Duque JC, Ortega Comunian L, Rezola Bajineta M, Segues Merino N. Cytologic Contamination of the Sampling Needle in Endobronchial Ultrasound. Arch Bronconeumol. 2022 Apr;58(4):367-368. doi: 10.1016/j.arbres.2021.07.011. Epub 2021 Aug 24. No abstract available. English, Spanish.
- Individual participant dataSharing planned: Yes. Individual participant data, such as age and gender, that are utilized in results for publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanglin Guo, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purge cleaning in people with Lung Cancer (Locally Advanced or Metastatic), run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanglin Guo, MD (601-984-5650, yguo@umc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytologic Contamination (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07461662, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.