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

Part of paid clinical trials in Jackson, Mississippi.

Sponsor
University of Mississippi Medical Center
Study ID
NCT07461662
Status
Not Yet Recruiting

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Conditions

  • Lung Cancer (Locally Advanced or Metastatic)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Purge cleaning — DIAGNOSTIC_TEST
    Additional flushing of the needle into a separate vial

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Purge cleaning
    Additional flushing of the needle into a separate vial.
  • No Intervention: Standard practice
    Standard saline flush following lesion sampling

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Mississippi Medical CenterJacksonMississippi39216
Yanglin Guo, MD
[email protected]
6019845650
Ricardo Ungo, MD
[email protected]
6019845660
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 (SUB_INVESTIGATOR)

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By research site
University of Mississippi Medical Center· Jackson, MS

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