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

NCT07461662 | Not Yet Recruiting FDA Device

• 1 other identifier: UMMC-IRB-2026-37
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer (Locally Advanced or Metastatic)

Keywords

Lung Cancer; Endobronchial ultrasound (EBUS) bronchoscopy; Cytologic Contamination; Cancer Staging

Outcome Measures

Primary Outcomes (1)

• Cytologic Contamination

  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 Outcomes (2)

• 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.

• 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.

Study Arms (2)

Purge cleaning

EXPERIMENTAL

Additional flushing of the needle into a separate vial.

Diagnostic Test: Purge cleaning

Standard practice

NO INTERVENTION

Standard saline flush following lesion sampling

Interventions

Purge cleaning DIAGNOSTIC_TEST

Additional flushing of the needle into a separate vial

Purge cleaning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age less than 18
• Recent (1 month or less) radiation or procedural manipulation of lymph node stations that may significantly change lymph node architecture

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (2)

• 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

  BACKGROUND

• 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.

  PMID: 35312544 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yanglin Guo, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanglin Guo, MD

CONTACT

601-984-5650; yguo@umc.edu

Ricardo Ungo, MD

CONTACT

601-984-5660; rungo@umc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine, Department of Medicine, University of Mississippi Medical Center

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)