Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Needle Research Articles

Utility of Acquire 22G-fine needle biopsy (FNB) needle vs the standard 22G needle during Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomized Controlled Trial (RCT)

ABSTRACT Background Various types of needles are available to perform endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). A relatively new needle for EBUS-TBNA, the Acquire Fine Needle Biopsy (FNB) device, has recently become available. Methods Consecutive subjects with lymphadenopathy >1 cm undergoing EBUS-TBNA were randomized to the Acquire 22-G EBUS-FNB needle and the standard 22-G EBUS-TBNA needle groups. Results A total of 86 subjects were randomized (43 in each group). The diagnostic yield of EBUS-TBNA was similar between the two groups: (36/43) 83.7% in the 22-G EBUS-FNB group and (34/43) 79.1% in the standard 22-G EBUS group (p = 0.58). The sampling adequacy, stations sampled, number of stations sampled, number of needle passes, and mean duration of the procedure between the two groups were also similar. Visible tissue clot core was obtained in a significantly greater proportion of subjects in the 22-G EBUS-FNB group (93.0% vs 46.5%, p < 0.001). Visibly bloody samples were more frequent in the 22-G EBUS-FNB group (74.4% vs 51.2%, p = 0.03). There was no difference in the complication rates between the two groups (p = 0.15). Conclusion We did not observe a difference in the diagnostic yield of the Acquire 22-G EBUS-FNB needle compared with the standard 22-G EBUS needle. Clinical trial registration Clinical Trial Registry of India (CTRI) https://ctri.nic.in/ (CTRI/2021/08/035589).

Franseen needle in endobronchial ultrasound-guided transbronchial needle aspiration: a phase II prospective study.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has been used to diagnose and stage lung cancer. Acquire™ Pulmonary and Expect™ Pulmonary dedicated EBUS-TBNA needles were introduced as the Franseen and Lancet needles, respectively. It is still unclear whether the Franseen or Lancet needles yield a higher quality specimen especially focusing on next-generation sequencing-based molecular testing. A single-center, prospective study performed at the Chiba University Hospital randomly assigned patients to two groups: Group A, wherein the first and second EBUS-TBNA were performed using Lancet and Franseen needles, respectively, and Group B, wherein the first and second EBUS-TBNA were performed using Franseen and Lancet needles, respectively. Each specimen was compared and analyzed pathologically. The primary outcome was the histological tissue area except blood clot and the cellularity of each sample. We also examined the success rate of molecular testing. Twelve patients who underwent EBUS-TBNA between November 2022 and February 2023 were enrolled in this study. The tissue area of the specimens obtained by the Franseen and Lancet needles was 13.3±6.4mm2 and 10.6±6.3mm2, respectively (P=.355). The tumor cellularity in the specimens obtained using the Franseen and Lancet needles was 54.0±30.3 and 46.2±36.3%, respectively (P=.608). The success rate of molecular testing using the single-pass sample by Franseen needle was 85.7 and 57.1% by Lancet needle. No serious complications were reported. The Franseen needle tended to show a greater amount of specimen with higher tumor cellularity than the Lancet needle which may contribute higher success rate of molecular testing. Further studies must be conducted to validate the results of this study. What is known and what is new? What is the implication, and what should change now?

Diagnostic Performance and Cell Count of EBUS-TBNA Needle Gauges: A Prospective Trial.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a well-established diagnostic procedure for evaluating hilar and mediastinal lymphadenopathies and is the gold standard for lung cancer diagnosis and staging. Recent studies assessed the effectiveness of the 19-G flex needle in obtaining larger EBUS-TBNA samples, and prospective small series gave similar results in terms of diagnostic yield when testing different gauge needles. The lack of homogeneity between series and the small sample size of some prospective cohorts poses a limit to the validity of those results. This prospective controlled study compared the 19-G flex and 22-G needles in terms of diagnostic yield. An objective laboratory method was used to count cells and compare the two needles' cytologic yields. A prospective controlled study was conducted on 90 patients undergoing EBUS-TBNA for the diagnosis of hilar and mediastinal lymphadenopathies. The institutional ethic committee (IEO573) approved the study, and informed consent was obtained from all patients. A total of 90 patients were enrolled in this study, 84.4% of whom were diagnosed with malignancy and 15.6% with non-neoplastic disease. Sensitivity for malignancy was 93.4% (CI: 87.4-97.1%) for the 19-G needle and 92.6% (CI: 86.3-96.5%) for the 22-G needle (p = 0.80). The percentage of malignant cells in the cell block was 63.9% and 61.5% for the 22-G and 19-G needles, respectively. The cell count assessed by flow cytometry was 2071 cells/µL (IQR: 600,2265) with the 22-G needle and 2761 cells/µL (IQR: 505,3250) with the 19-G needle (p = 0.79). The malignant cell count was 0.05 × 103 cells/µL with the 22-G and 0.08 × 103 cells/µL with the 19-G needle (p = 0.70). There was no difference in the presence of tissue cores in the samples, and rapid on-site evaluation (ROSE) cellularity was comparable between the two needles. The 19-G flex EBUS-TBNA needle is comparable to the 22-G needle in terms of diagnostic yield for cyto-histological evaluation of hilar and mediastinal lymphadenopathies. There is no difference between the 19-G and 22-G needle cell counts evaluated by flow cytometry.

Diagnostic performance of 19-gauge endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in suspected lymphoma: A prospective cohort study.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) represents a minimally invasive approach in the evaluation of mediastinal/hilar lymphadenopathy. Diagnostic performance of EBUS-TBNA in lymphoma using standard 22-gauge (22G) needle is limited by sample volumes that are often inadequate for histopathological assessment. To evaluate the diagnostic utility of 19-gauge (19G) EBUS-TBNA needle in the evaluation of suspected lymphoma. We prospectively collected clinical and procedural information for patients undergoing EBUS-TBNA with 19G needle at Royal Melbourne Hospital for investigation of mediastinal/hilar lymphadenopathy, where lymphoma was considered in the differential diagnosis. All consecutive patients between June 15, 2016 and July 10, 2019 were included. If definitive diagnosis was not achieved on EBUS-TBNA, final diagnosis was determined through subsequent investigation or a minimum of 6 months radiologic surveillance. Thirty-nine patients underwent EBUS-TBNA using 19G needle for evaluation of suspected lymphoma. Thirteen patients had a prior diagnosis of lymphoma (33%). Lymphoma was ultimately diagnosed in 23 patients (59%). Of these, 10 had a prior diagnosis of lymphoma (43%). 19G EBUS-TBNA demonstrated lymphoma in 19 patients, with a sensitivity of 83% (95% CI 66-93) for detection of lymphoma. Four patients required surgical biopsy to definitively characterise lymphoma subtype. Therefore, sensitivity of 19G EBUS-TBNA for definitive diagnosis of lymphoma was 65% (95% CI 45-81). In patients with a prior diagnosis of lymphoma, sensitivity for definitive diagnosis of lymphoma was 80% (95% CI 48-95). Diagnostic performance of 19G EBUS-TBNA appears similar to standard 22G needle in detection and definitive diagnosis of lymphoma. Further invasive testing remains necessary following non-diagnostic EBUS-TBNA procedures.

Clinical Usefulness of Fungal Culture of EBUS-TBNA Needle Rinse Fluid and Core Tissue.

PurposeThe diagnosis of pulmonary fungal infections is challenging due to the difficulty of obtaining sufficient specimens. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) needle rinse fluid has become an emerging diagnostic material. This study evaluated the role of routine fungal culture from EBUS-TBNA needle rinse fluid, in addition to histopathologic examination and fungal culture of EBUS-TBNA core tissue, in the diagnosis of pulmonary fungal infections.Materials and MethodsAmong patients who underwent EBUS-TBNA, those with results for at least one of three tests (histopathologic examination, fungal culture of EBUS-TBNA core tissue or needle rinse fluid) were included. Patients with a positive test were divided into two groups (clinical fungal infection and suspected fungal contamination) according to their clinical assessment and therapeutic response to antifungal.ResultsOf 6072 patients, 41 (0.7%) had positive fungal tests and 9 (22%) were diagnosed as clinical fungal infection. Of the 5222 patients who were evaluated using a fungal culture from EBUS-TBNA needle rinse fluid, 35 (0.7%) had positive results. However, only 4 out of 35 (11.4%) were classified as clinical fungal infection. Positive results were determined in 4 of the 68 (5.9%) evaluated by a fungal culture of EBUS-TBNA core tissue, and all were diagnosed as clinical fungal infection.ConclusionRoutine fungal culture of EBUS-TBNA needle rinse fluid is not useful due to the low incidence of fungal infection and high rate of contamination. However, fungal culture of EBUS-TBNA core tissue and needle rinse fluid should be considered in patients with clinically suspected fungal infection.

POLICY CHANGES AFTER A RARE COMPLICATION OF EBUS-TBNA: EXPECTORATION OF A METAL SHEATH

SESSION TITLE: Wednesday Fellows Case Report Posters SESSION TYPE: Fellow Case Report Posters PRESENTED ON: 10/23/2019 09:45 AM - 10:45 AM INTRODUCTION: Since the first application of ultrasound in the airway in 1992, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has become a widely-used effective and minimally invasive method of diagnosing and staging mediastinal lymph nodes and masses. The procedure is generally well-tolerated. Major complications involving EBUS-TBNA are low, but there are increasing reports of procedure-related complications. We present a case of a retained inner metal sheath of the Olympus EBUS-TNBA needle catheter after instrument malfunction. CASE PRESENTATION: A 47-year old male was referred for EBUS-TBNA for worsening cough for the past year. A computed tomography of the chest revealed bilateral hilar and mediastinal adenopathy concerning for sarcoidosis. Endobronchial ultrasound was used to assist with guiding biopsy of hilar and mediastinal regions. An EBUS-TBNA was performed using an Olympus EBUS-TBNA 22-gauge needle. Specimens were obtained from the 7, 10R, and 11L lymph nodes. During sampling of the left interlobar lymph node, there was unexpected resistance when attempting to advance the needle. The needle was repositioned and the lymph node was aspirated without further difficulty. Rapid On-Site Evaluation revealed non-necrotic granulomatous tissue of the subcarinal lymph node. The tracheobronchial tree was examined to at least the first sub-segmental level. Bronchial mucosa and anatomy were normal with no endobronchial lesions, secretions or foreign bodies visualized. The patient tolerated the procedure well and was discharged. On his way home, the patient reported expectorating “a metal sheath.” The Olympus EBUS-TBNA needle catheter was examined and it was discovered that the inner metal sheath located in the distal plastic sheath of the needle catheter was missing which corresponded to the inner metal sheath of the needle catheter. The patient did not have any complications from this event. DISCUSSION: EBUS-TBNA is the preferred modality in the diagnosis and staging of mediastinal lymph nodes and masses with high specificity and sensitivity. Serious EBUS complication rates range from 0.15-0.16%, including mediastinal abscess, empyema, needle fracture, and hemo-pneumomediastinum, Literature review showed a single case report of an expectorated “stent” from EBUS-TBNA. Due to the malfunction of the needle catheter, a root-cause analysis was performed and protocol changes were subsequently made to our institutional policy. CONCLUSIONS: EBUS-TBNA is accepted as a safe, well-tolerated procedure with low major complication rates. Our case is only the second reported case of assembly malfunction causing unexpected deployment of the inner metal sheath into the bronchi. While no serious complications resulted from this, providers performing EBUS-TBNA need to be aware of this potential device malfunction. We recommend routine inspection of the needle apparatus pre- and post-procedure. Reference #1: Caglayan BYilmaz A, et al. Complications of Convex-Probe Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: A Multi-Center Retrospective Study. Respir Care. 2016 Feb;61(2):243-8. Reference #2: Zamora FD, Moughrabieh A, et al. An Expectorated "Stent": An Unexpected Complication of EBUS-TBNA. J Bronchology Interv Pulmonol. 2017 Jul;24(3):250-252. Reference #3: Asano F, Aoe M, Ohsaki Y, et al. Complications associated with endobronchial ultrasound-guided transbronchial needle aspiration: a nationwide survey by the Japan Society for Respiratory Endoscopy. Respir Res. 2013;14:50 DISCLOSURES: No relevant relationships by Michael Ayers, source=Web Response No relevant relationships by Ngoc-Tram Ha, source=Web Response No relevant relationships by Cynthia Tsai, source=Web Response

Tissue Acquisition During EBUS-TBNA: Comparison of Cell Blocks Obtained From a 19G Versus 21G Needle.

Previous studies have shown that needle gauge size has no significant impact on diagnostic yield during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Our objective was to determine whether cell blocks obtained via the new Flex 19G EBUS-TBNA needle would contain more cellular material based on cell area compared with those obtained from a 21G needle. A prospective analysis of patients undergoing EBUS-TBNA at our institutions was performed. Sampling of the same lesion(s) with both the Flex 19G and 21G needles was performed in an alternating manner. In total, 47 patients with suspected lung cancer or mediastinal/hilar lymphadenopathy were included with a total of 83 lesions biopsied. Cell block area was calculated using the Aperio ImageScope software. Mean cell area in the Flex 19G group was 7.34±12.46 mm compared with 5.23±10.73 mm in the 21G group (P=0.02). In the malignant subgroup, the average cell area was 16.16±16.30 mm in the Flex 19G group versus 11.09±15.55 mm in the 21G group (P=0.02). No significant difference was noted in the mean cell area within the nonmalignant subgroup, 1.80±3.01 mm in the 19G group versus 1.56±1.79 mm in the 21G group (P=0.60). The cell area obtained via the 19G needle was significantly larger than that obtained with the 21G needle. Further multicenter randomized studies are needed to identify the utility of the Flex 19G needle in diagnosing/subtyping lymphoproliferative disorders and adequacy for molecular testing in non-small cell lung cancer.

Effect of Routine Clopidogrel Use on Bleeding Complications After Endobronchial Ultrasound-guided Fine Needle Aspiration.

Endobronchial ultrasonography has proven to be highly sensitive and specific in the diagnoses of patients with mediastinal and hilar adenopathy. Many of these patients are on a combination of clopidogrel (a compound that inhibits adenosine diphosphate-induced platelet aggregation) and aspirin due to neurological and/or cardiac-related comorbidities, and stopping anticoagulation may place these patients at high risk for potential complications. Our group has previously showed that thoracentesis with an 8-french catheter is safe in patients receiving clopidogrel and aspirin with low risk of complications. In this manuscript, we report the outcomes of the largest prospective multicenter series of patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) while receiving clopidogrel. Patients presenting to our institutions with mediastinal/hilar adenopathy, requiring EBUS-TBNA, and actively taking clopidogrel and aspirin were included in the study. If the medication could be held for 5 to 7 days before the procedure, the patient was excluded. EBUS-TBNA was performed by an interventional pulmonology faculty on a total of 42 patients. All patients received total intravenous anesthesia, and a total of 92 nodes were sampled. First, 3 passes were performed with a 22-G needle. If no complications were encountered, we followed with additional 3 passes with a 21 G. Rapid onsite evaluation was performed in all patients. Bleeding at the puncture site was considered significant if it required cold saline, topical sympathomimetic, or balloon tamponade for hemostasis. Bleeding was considered nonsignificant if no interventions were required to achieve hemostasis. We were able to perform all procedures successfully using both the 21 and 22-G needles. One patient required 30 mL cold saline installation to accomplish hemostasis with the 21 and 22-G needles. Our yield was comparable with the current literature. No statistically significant complications occurred during the procedure. All patients were contacted within 24 hours, and none reported bloody sputum. We suggest that EBUS-TBNA, using 22 and 21-G needles, is safe with high yields in patients with mediastinal/hilar adenopathy, actively taking clopidogrel and aspirin, and are at high risk for thrombotic complications if the medication is discontinued.

Needle wash solution cultures following EBUS-TBNA with or without endobronchial intubation.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive procedure with a high diagnostic yield in lesions adjacent to the airways. However, complications associated with EBUS-TBNA, such as mediastinitis, have recently been reported. Oral bacteria contamination in punctured lymph nodes can cause severe infections. In the current study, we investigated whether endobronchial intubation using EBUS-TBNA can prevent oral bacterial contamination of punctured lymph nodes. We retrospectively evaluated 80 patients (102 lymph nodes) who had undergone EBUS-TBNA and divided them two groups: Group A comprised 60 patients who had undergone EBUS-TBNA with endobronchial intubation and Group B consisted of 20 patients who had undergone EBUS-TBNA without endobronchial intubation. The patients' medical records were examined and the two groups were compared using the unpaired Student's t-test. EBUS-TBNA needle wash cultures were positive in only two Group A cases (3.3%), but in all 20 Group B cases (100%) (P < 0.05). Except for one case of Mycobacterium tuberculosis, all bacterial isolates yielded typical oropharyngeal commensal flora. Fever (≥ 38.0 °C) was observed in six Group A cases (10%) and two Group B cases (10%; P = 0.526). This was treated by cooling, a single administration of non-steroidal anti-inflammatory drugs, and/or antibiotic therapy. Fever was not associated with any clinical features, including malignancy in punctured lesions, number of punctures, echo features, simultaneous peripheral biopsy, additional oral prophylactic antibiotics, or positive needle wash cultures. Endobronchial intubation may prevent contamination by oropharyngeal commensal bacteria.

Clinical evaluation of the utility of a flexible 19-gauge EBUS-TBNA needle.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is an established modality for the assessment of mediastinal and hilar adenopathy. To overcome the sampling limitations of standard 21- and 22-gauge EBUS-TBNA needles, a new flexible 19-gauge (Flex 19G) needle was developed. We performed a retrospective analysis of patients who underwent EBUS-TBNA sampling with the Flex 19G needle. A 22G needle was always used first for cytology, followed by a Flex 19G needle, either an early version (Oct/2014-Sep/2015) or a final version needle (May/2016-Jan/2017), for tissue sampling. The success rate of obtaining samples, specimen quantity, and safety were evaluated and compared. All sampling procedures in 45 patients and 82 targets were performed without complication and the overall diagnostic yield from cytology was 100%. Furthermore, 28% of Flex 19G samples were sufficient for histopathological diagnosis. Yield improved with an increased number of passes and if the target was larger. Compared to the early version evaluated in 52 targets, the final version of the Flex 19G needle evaluated in 30 targets provided significantly larger volume samples and more frequent diagnostic cores. Tissue obtained with the Flex 19G needle retained cohesiveness to a larger degree and was of higher cellularity compared to cytological samples processed as cell blocks. The Flex 19G is safe and provides larger volumetric and cohesive tissue samples that are appropriate for histopathological processing. The final version of the Flex 19G could be a good choice in selected cases where greater tissue acquisition is required.

Endobronchial ultrasound-guided transbronchial needle aspiration in the economically disadvantaged: A retrospective analysis of 1582 individuals.

Background:Whether the indications and diagnostic yield of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) vary according to the socioeconomic status of the patient, remains unknown. Herein, we evaluate this aspect in participants who underwent EBUS-TBNA.Materials and Methods:This is a retrospective analysis of all participants who underwent EBUS-TBNA for the evaluation of intrathoracic lymphadenopathy. We evaluated the indications and outcome of EBUS-TBNA in participants with and without economic disadvantage (issuance of a below poverty line card by the government).Results:Of the EUBUS procedures performed on 1582 participants (mean [standard deviation] age, 46.1 [15.7] years; 593 [37.5%] women) performed during the study, 61 (3.9%) were done in the economically disadvantaged (ED) group. Individuals in the ED group were younger (median age, 40 vs. 46 years; P = 0.002) and more likely to have tuberculosis (42.6% vs. 26.2%, P = 0.005) or malignancy (39.3% vs. 26.9%, P = 0.032) as a presumptive diagnosis. The overall diagnostic yield of EBUS was 63% and was significantly lower in the ED group (49.2% vs. 63.5%, P = 0.023). Previously used EBUS-TBNA needles were more commonly employed in the ED participants (62.7% vs. 20.1%, P < 0.001). On multivariate logistic regression analysis, younger age, larger size, and number of nodes sampled, and the use of new (versus reused) needles were independent predictors of higher diagnostic yield. There was no difference in the complication rate between the two groups.Conclusion:The diagnostic yield of EBUS was significantly lower in the ED participants, which is due to the differences in the clinical and procedural characteristics.

A Preclinical Evaluation Comparing the Performance of a Novel 19-G Flexible Needle to a Commercially Available 22-G EBUS-TBNA Sampling Needle

Background: Needle samples may not provide sufficient diagnostic material for the assessment of mediastinal lymph nodes. Objective: The study compared the specimen size and diagnostic performance of a new 19-G endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) needle to that of a standard 22-G EBUS-TBNA needle in a swine model of granulomatous lymphadenopathy. Methods: Granulomatous inflammation was induced in mediastinal lymph nodes (LNs) of 10 domestic swine by injection of talc slurry. The affected LNs were sampled with the 19- and 22-G needles. Collected core tissue area and volume were determined using a specialized software and known needle internal diameter. The sample's quality was assessed using the biopsy core morphology grade (BCMG) as well as the biopsy diagnostic correlation grade (BDCG). Results: There was a significant increase in the average LN size from baseline (11.6 ± 3.2 to 15.2 ± 3.8 mm; p < 0.001) after talc injection. A total of 132 paired samples were collected from 38 LNs. The average mass and volume of the 19-G needle sample were larger than those of the 22-G needle sample: 33.78 ± 47.48 vs. 25.18 ± 32.08 mg (p < 0.002) and 11.40 ± 13.91 vs. 6.91 ± 6.42 mm³ (p < 0.0004), respectively. The pooled needle biopsy samples for the 19- and the 22-G needles had similar BCMG (1.38 ± 0.86 vs. 1.43 ± 0.87, p > 0.2) and BDCG (1.54 ± 0.93 vs. 1.57 ± 0.93, p > 0.2). The 19-G needle samples tended towards less blood contamination (p = 0.057), more often granuloma identification (46 vs. 32%, p = 0.2) and had more cartilage contamination (0.49 ± 1.46 vs. 4.81 ± 16.49% p < 0.003). Conclusion: In experienced hands, the 19- and the 22-G EBUS-TBNA needles have a similar diagnostic yield in the swine model of granulomatous lymphadenopathy. The samples collected by the 19-G needle are larger and may have less blood contamination.

Training and certification in endobronchial ultrasound-guided transbronchial needle aspiration.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) plays a key role in the staging of lung cancer, which is crucial for allocation to surgical treatment. EBUS-TBNA is a complicated procedure and simulation-based training is helpful in the first part of the long learning curve prior to performing the procedure on actual patients. New trainees should follow a structured training programme consisting of training on simulators to proficiency as assessed with a validated test followed by supervised practice on patients. The simulation-based training is superior to the traditional apprenticeship model and is recommended in the newest guidelines. EBUS-TBNA and oesophageal ultrasound-guided fine needle aspiration (EUS-FNA or EUS-B-FNA) are complementary to each other and the combined techniques are superior to either technique alone. It is logical to learn and to perform the two techniques in combination, however, for lung cancer staging solely EBUS-TBNA simulators exist, but hopefully in the future simulation-based training in EUS will be possible.

Initial Polish experience of Flexible 19 gauge Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration.

EBUS is a well established minimally invasive diagnostic tool for mediastinal and hilar lymphadenopathy. The novel ViziShot Flex 19G needle (Olympus Respiratory America, Redmond, WA, USA) was introduced in 2015 in order to improve loaded scope flexion and to obtain larger tissue samples for analysis. The aims of this study were to assess diagnostic yield of Flex 19G needles and to present endoscopist's feedback about the endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). The Flex 19G needles were used in patients with hilar and/or mediastinal adenopathy in two Polish pulmonology centers. Cytology smears and cell blocks (CB) were prepared. The prospective analysis was performed due to collected data. Twenty two selected patients with confirmed adenopathy on chest-CT (mean age 58 ± 12) underwent EBUS-TBNA with use of Flex 19G needles. All procedures occurred to be diagnostic for smears (yield 100%). The malignancy was found in 15 cases (68.2%), and benign adenopathy in 7 (31.8%). In 12 of 14 cases of lung cancer (yield 85.7%) CB were diagnostic for immunohistochemical and molecular staining. After puncturing nodes, especially in hilar position not extensive bleeding was observed. Comparing to standard 21/22G EBUS-TBNA endoscopists underlined better flexion of loaded scope and sample adequacy and found non-significant differences in another biopsy details. The first Polish experience with use of Flex 19G EBUS-TBNA needle occurs to be similar in performance with standard technique with use of 22/21G needles and presents high diagnostic yield for lung cancer diagnostics, especially when preparing CB. A safety profile of the biopsy is acceptable.

A Novel 19g EBUS-TBNA Needle: Results of Ex Vivo Tissue Evaluations

SESSION TITLE: Advancements in Lung Cancer Diagnostics and Treatment SESSION TYPE: Original Investigation Slide PRESENTED ON: Wednesday, October 26, 2016 at 08:45 AM - 10:00 AM PURPOSE: Endobronchial ultrasound - guided transbronchial needle aspiration (EBUS-TBNA) is now widely used for mediastinal lymph node staging in lung cancer patients and diagnosis of other lymph node adenopathies. The commercially available needles for these procedures are currently limited to 21G, 22G and 25G sizes. A new 19G needle compatible with EBUS bronchoscopes has been developed with a goal to collect larger volumetric samples. We report the results of the bench testing performed to compare the sample collection of these 19G needles to commercially available 21G and 22G needles. METHODS: ViziShot FLEX 19G needles (Olympus Respiratory America, Redmond, WA) and ViziShot 21G and 22G needles (Olympus, Tokyo, Japan) were evaluated under controlled conditions. Fresh pieces of bovine heart and liver were used as substrates. Heart tissue was chosen as a surrogate for hypertrophic, dense lymph node and liver served as surrogate for normal lymph node. Five devices of each kind were tested. Each needle was penetrated by hand 2cm into the tissue target at an angle resembling EBUS-TBNA. Ten agitations using 20cc of vacuum were performed consistently to collect samples. Each sample was ejected using air onto slides. The tissue core was then arranged using a fine needle to remove any overlapping and stacking. The samples were photographed using a high power microscope. The sample images were analyzed using image analysis software (ImageJ, NIH, Bethesda, MD) to calculate the tissue core area. To obtain sample volume, the sample depth was extrapolated from the needles’ inner diameter and then the tissue core area of each sample was multiplied by the sample depth. The sample volume collected by each needle was statistically compared using an unpaired t-test. RESULTS: A total of 15 needle samples from heart and 15 samples from liver were collected. Image analysis of the samples showed that the 19G needles produced statistically larger volume tissue cores than either the 21G or 22G needles (p< 0.01). In liver only, the 21G needles collected statistically larger volume tissue cores compared to the 22G needles (p<0.01). For all evaluations and comparisons, the liver tissue provided statistically larger volumetric samples compared to the denser heart tissue (p<0.01). CONCLUSIONS: In both ex-vivo tissue substrates, the ViziShot FLEX 19G needle provided a significantly larger amount of tissue material compared to the 21G and 22 G needles. The volume of sample collected also depends on the density of the tissue target. Evaluations in patients are warranted to confirm these results. CLINICAL IMPLICATIONS: There is a clinical need for larger EBUS-TBNA samples with more material for histological assessment and molecular analysis. This evaluation shows that the 19G EBUS-TBNA needles collect more material which could be of clinical utility. This information could also guide bronchoscopists in needle selection for their cases. DISCLOSURE: Sujeeth Parthiban: Employee: Receive salary from Olympus Respiratory America David Dillard: Employee: Receive salary from Olympus Respiratory America Anna Sczaniecka: Employee: Receive salary from Olympus Respiratory America Xavier Gonzalez: Employee: Receive salary from Olympus Respiratory America No Product/Research Disclosure Information

Diagnostic value of core biopsy histology and cytology sampling of mediastinal lymph nodes using 21-gauge EBUS-TBNA needle.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the initial modality of choice in sampling mediastinal lymphadenopathy. It is possible to obtain both cytological and histological samples using both 21-gauge and 22-gauge EBUS-TBNA needles. The current study was undertaken to compare the diagnostic yield of cytology and histology samples obtained by the same EBUS-TBNA 21-gauge needle. One hundred sixty-six consecutive patients who underwent EBUS-TBNA with a 21-gauge EBUS-TBNA needle over a period of 3 years were included in this retrospective analysis. The diagnostic yields of EBUS-TBNA histology (EBUS-TBNA-H) and EBUS-TBNA cytology (EBUS-TBNA-C) specimens were compared using the McNemar test. The overall sensitivity and specificity of EBUS-TBNA were 89% and 100%, respectively. The positive predictive value (PPV) and negative predictive value (NPV) of EBUS-TBNA were 100% and 53%, respectively. The overall sensitivity and specificity of EBUS-TBNA-H were 85% and 100%, respectively. The PPV and NPV of EBUS-TBNA-H were 100% and 43%, respectively. The overall sensitivity and specificity of EBUS-TBNA-C were 65% and 100%, respectively. The PPV and NPV of EBUS-TBNA-C were 100% and 14%, respectively. The diagnostic yield of EBUS-TBNA-H over EBUS-TBNA-C was statistically significant (P < 0.0001). EBUS-TBNA-H with 21-gauge needle significantly improves the diagnostic yield of EBUS-TBNA. EBUS-TBNA-H improves the NPV of EBUS-TBNA. The combination of EBUS-TBNA-H and EBUS-TBNA-C improves the overall diagnostic yield of EBUS-TBNA.

Impact of needle gauge on characterization of endobronchial ultrasound‐guided transbronchial needle aspiration (EBUS‐TBNA) histology samples

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive mediastinal node sampling technique used for lung cancer staging and diagnosis of mediastinal lesions. The four published studies assessing sampling with 21-G or 22-G needles conflict. The study objective is to evaluate the diagnostic utility of 21-G versus 22-G EBUS-TBNA needles, and the ability to subcharacterize both benign and malignant lesions using histopathological assessment only. A retrospective analysis was performed from 303 patients referred for EBUS-TBNA between January 2011 and July 2013. Sampling needle gauge was selected at the discretion of the operator. Samples were assessed by histopathologists blinded to the needle gauge without rapid on-site evaluation for cytology. Contingency table analysis was performed to compare diagnostic utility and ability to subcharacterize malignant and benign lesions. No difference in diagnostic ability was seen for malignancy (96.6% vs. 95.3% accuracy, 21-G vs. 22-G). Subgroup analysis of benign 21-G tissue samples revealed superior characterization compared with 22-G samples (63/76, 83%, vs. 31/52, 60%, P < 0.01). Characterization of non-small cell lung cancer (NSCLC) was also significantly better with samples obtained with 21-G needles versus 22-G needles (57/65, 88% vs. 34/52, 65%, P < 0.01). This large UK single-centre study suggests 21-G EBUS-TBNA needles are superior to 22-G in characterizing benign lesions (especially sarcoidosis) and NSCLC when using histopathological assessment. Making a positive benign diagnosis may avoid the need to perform mediastinoscopy. Obtaining sufficient histological material to subcharacterize NSCLC and particularly lung adenocarcinoma allows appropriate testing for genetic mutations facilitating targeted oncological therapy.

The Cryo-Needle: A New Tool for Histological Biopsies. A Feasibility Study

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a standard procedure for intrathoracic lymph node biopsies. The newly developed cryo-needle operates in a similar way to the EBUS-TBNA but is able to obtain specimens for histological evaluation. The purpose of this animal study was to evaluate the feasibility, effect, and safety of the cryo-needle biopsies. Four EBUS-guided cryo-needle biopsies were obtained from a mediastinal lymph node of a healthy pig. In an open surgery approach, cryo-needle biopsies using activation times of 1, 2, and 3s (A1/A2/A3) and needle biopsies using a 21-gauge EBUS-TBNA needle were obtained from mesenteric lymph nodes. Cryo-needle biopsies A2 were performed with (A2+) and without (A2-) an oversheath. The size, weight, percentage of lymphatic tissue and artefact-free area of each cryobiopsy were evaluated. Smears were made with the TBNA-needle aspirates to determine the number of lymphocytes per high-power field (HPF). The bleeding duration was measured. We successfully obtained EBUS-guided cryo-needle biopsies. The area and weight of the biopsies A3 and A2+ were significantly larger compared with A1 (1.7±0.8 and 1.4±0.3 vs. 0.9±0.4mm(2); 5.2±2.4 and 3.4±1.8 vs. 1.5±0.7mg). The percentage of lymphatic tissue of the cryobiopsies was 90±25 and 98% of samples were artefact-free. The number of lymphocytes/HPF of TBNA-needle smears was 128±54.3. There was no difference in bleeding duration between the techniques. The cryo-needle yields large histological specimens of high quality.

Diagnostic Value of Blood Clot Core During Endobronchial Ultrasound-Guided Transbronchial Needle Aspirate

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is being increasingly used in the sampling of pulmonary masses and mediastinal lymphadenopathy. The blood clot core (BCC) often obtained during EBUS-TBNA may not be a true core and therefore may not be submitted for histological analysis. The frequency in which the blood clot core is positive in patients with negative cytology undergoing EBUS-TBNA is not known. The purpose of this study was to evaluate the diagnostic role of the blood clot core obtained during EBUS-TBNA. An Institutional Review Board-approved retrospective chart review was performed from January through September 2011 for all patients who underwent EBUS-TBNA at The Ohio State University. The data collection included cytology and histology results for each procedure. Blood clot cores obtained from the EBUS-TBNA needle were sent in formalin for histological examination. Seventy patients underwent EBUS-TBNA and 51 (72.8%) patients had procedures that yielded a BCC for histology and aspirate for cytology. Forty-nine percent of patients with a BCC were diagnosed with malignancy. Of those with a BCC obtained, five (9.8%) patients diagnosed with malignancy were done so based only on the results of blood clot core alone with negative cytology. Blood clot cores obtained at EBUS-TBNA contain diagnostic material and should be subjected histopathological examination. When blood clot cores are sent for analysis, there is the potential to spare up to 10% of patients more invasive diagnostic biopsy procedures.