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

March 4, 2026 updated by: Yanglin Guo, University of Mississippi Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yanglin Guo, MD
  • Phone Number: 601-984-5650
  • Email: yguo@umc.edu

Study Contact Backup

  • Name: Ricardo Ungo, MD
  • Phone Number: 601-984-5660
  • Email: rungo@umc.edu

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
        • Contact:
          • Yanglin Guo, MD
          • Phone Number: 6019845650
          • Email: yguo@umc.edu
        • Contact:
        • Sub-Investigator:
          • Ricardo Ungo, MD
        • Sub-Investigator:
          • Walter Rose, MD
        • Sub-Investigator:
          • Mick Kelly
        • Sub-Investigator:
          • George Abraham, MD
        • Sub-Investigator:
          • Michal Senitko, MD
        • Sub-Investigator:
          • Varsha Manucha, MD
        • Sub-Investigator:
          • Agha Baqir, MD
        • Sub-Investigator:
          • Swathi Yarlagadda, MD
        • Sub-Investigator:
          • Syed Abbas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Purge cleaning
Additional flushing of the needle into a separate vial.
Diagnostic test: Purge cleaning
Additional flushing of the needle into a separate vial
No Intervention: Standard practice
Standard saline flush following lesion sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
To evaluate the incidence of pathological upstaging based on our primary outcome findings
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: Yanglin Guo, MD, University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMMC-IRB-2026-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data, such as age and gender, that are utilized in results for publication will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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