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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Purge cleaning
  Additional flushing of the needle into a separate vial

Первичные конечные точки

• Cytologic Contamination [Срок оценки: 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.]

Вторичные конечные точки (2)

• Incidence of Pathological Upstaging [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• University of Mississippi Medical Center — Jackson

Публикации

• 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. PMID 35312544

Идентификаторы

NCT: NCT07461662 · UMMC-IRB-2026-37

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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