Clinical trial · Interventional
Evaluation of Endobronchial Ultrasound Needle Cleaning Techniques and Their Impact on Specimen Contamination
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (Locally Advanced or Metastatic) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Purge cleaning | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Purge cleaning
- description
- Additional flushing of the needle into a separate vial.
- interventionNames
- Diagnostic Test: Purge cleaning
- type
- NO_INTERVENTION
- label
- Standard practice
- description
- Standard saline flush following lesion sampling
Primary outcomes (1)
- measure
- Cytologic Contamination
- timeFrame
- 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.
- description
- To determine the presence of cytologic contamination following standard practice cleaning techniques
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- 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
- BACKGROUNDTirapu 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