Gnass, Maciej

Kużdżał, Jarosław

Misiaszek, Magdalena

Rudnicka-Sosin, Lucyna

Soja, Jerzy

Szlubowski, Artur

Polish Archives of Internal Medicine

English

Jagiellonian Univeristy Repository

POLISH ARCHIVES OF INTERNAL MEDICINE 2020; 130 (6)550needle biopsies can sometimes provide such a sample, but if EBUS ‑TBNA is not conclusive, mediastinoscopy is still a confirmatory test.6The aim of this study was to evaluate efficacy of EBUS/EUS ‑b‑NA using histological 25G core needles in a detailed diagnosis of patients with advanced LC.Patients and methods A single ‑center prospec‑tive observational study was conducted in John Paul II Hospital in Kraków, Poland. Consecutive patients with confirmed or suspected advanced LC were included. Since the procedure is routine‑ly used, the approval of bioethics committee was not required.After the  informed consent was obtained, the EBUS/EUS ‑b‑NA procedure was performed under mild conscious sedation with intravenous midazolam (2–5 mg) and fentanyl (0.025–0.1 mg). Flexible videobronchoscopes with a integrated convex ultrasound probe (BF ‑UC180F, Olympus Medical Systems Corporation, Tokyo, Japan), which can visualize mediastinal and hilar struc‑tures, were used for all procedures. The biopsies were performed with 25G core needles (Echo‑Tip ProCore Endobronchial HD Biopsy Needle, Cook Endoscopy Inc., Limeric, Ireland) with 2 to 5 needle passes in at least 2 selected areas. Both the smears and the cell blocks were prepared from obtained samples.If the biopsy specimen was positive for LC, it was sent to perform IHC tests: thyroid tran‑scription factor 1 (TTF‑1), p40, CD56, Ki67. If non–small cell lung cancer was diagnosed, the specimen was sent to run molecular test‑ing for mutations of epidermal growth factor re‑ceptor, translocations of anaplastic lymphoma Introduction Lung cancer (LC) remains the most common cause of cancer ‑related mortality world‑wide. Despite the efforts made to detect it early, only 15% to 20% of newly diagnosed LC patients are in early stages at the time of the diagnosis and are eligible for surgical treatment. A target‑ed oncological treatment should be considered in the majority of patients with advanced LC (stage IIIB and IV). It is important to obtain from the le‑sions adequate cytological or histological samples that are suitable for immunohistochemistry (IHC) and broader molecular testing (MT).1A combination of positron emission tomog‑raphy with computed tomography and minimal‑ly invasive procedures including endobronchial ultrasound ‑guided transbronchial needle aspi‑ration (EBUS ‑TBNA) and endoscopic ultrasound‑‑guided fine‑needle aspiration (EUS ‑b‑FNA) with single EBUS scope is a standard procedure in LC staging.2 Recent guidelines on the tech‑nical aspects of EBUS ‑TBNA recommend using a 22 ‑gauge (G) or 21G cytological needle.3For decades, transthoracic and transabdominal core needle biopsies have been the standard pro‑cedures for the diagnostic workup of malignan‑cies.4 Both thicker cytological 19G needles and core histological 22G / 25G needles proved to be useful in performing core EUS ‑guided biopsies in gastroenterology5 (see also references 1 and 2 in Supplementary material). Thereafter, histologi‑cal core needles started to be used endobronchi‑ally, but their efficacy to obtain sufficient mate‑rial for IHC and MT in the diagnostic workup of patients with LC is still unknown.In some cases, it is crucial to assess the his‑tological structure of the lesion to diagnose and treat the patient correctly (eg, lymphoma). Core RESEARCH LETTEREndosonography with 25 ‑gauge core needles for immunohistochemistry and molecular testing in lung cancer patients: a feasibility studyMagdalena Misiaszek1, Maciej Gnass1, Lucyna Rudnicka2, Jerzy Soja3, Jarosław Kużdżał4, Artur Szlubowski11  Endoscopy Unit, John Paul II Hospital, Kraków, Poland2  Department of Pathology, John Paul II Hospital, Kraków, Poland3  Department of Medicine, Jagiellonian University Medical College, Kraków, Poland4  Department of Thoracic Surgery, Jagiellonian University Medical College, Kraków, PolandCorrespondence to:Maciej Gnass, MD, PhD, Endoscopy Unit, John Paul II Hospital, ul. Prądnicka 80, 31-202 Kraków, Poland, phone: +48 12 614 23 09, email: m.gnass@gmail.comReceived: March 8, 2020.Revision accepted: May 13, 2020.Published online: May 18, 2020.Pol Arch Intern Med. 2020; 130 (6): 550-552doi:10.20452/pamw.15364Copyright by the Author(s), 2020RESEARCH LETTER 25G core needles for immunochemistry and molecular tests in lung cancer 551with the standard 22G needle. A maximum exten‑sion of this needle is 5 cm.8 Nevertheless, the lit‑erature describing usefulness of this needle in ob‑taining material suitable for IHC and MT is scarce.Our study showed that 25G ProCore needles can be successfully used for this purpose. Those results must be considered as preliminary and re‑quiring further investigation, because our study had its limitations, namely, a small group of pa‑tients and a noncomparative protocol.Also considering statistical analysis, both ac‑curacy and PPV are influenced by a selection bias, so their value is limited.There is only one retrospective review com‑paring core biopsy needles (EchoTip 22/25G Pro‑Core) with standard ones (SonoTip II 22G) in which a yield obtained by the first one was im‑proved comparing with the standard one in test‑ing for malignancy.9 On the other hand, more re‑cent data do not show significant difference be‑tween 22G and 25G cytological needles regard‑ing specimen adequacy for histology and molec‑ular testing.10,11Also, the comparison between 22G and 25G ProCore needles for mediastinal and hilar lymph‑adenopathy presented by Yang et al12 did not show significant difference in the diagnostic yield.As the core needles are significantly more ex‑pensive, and their diagnostic yield seems to be of no advantage comparing with standard ones, it is necessary to identify the precise indications for the use of 25G ProCore in clinical practice. The data from the literature is very limited (see references 3 and 4 in Supplementary material). However, both conclusions drawn by other au‑thors and our experience point to improvement of flexibility of EBUS scope loaded with a 25G needle, which is important in puncturing both the upper paratracheal region and peripheral hi‑lar lesions / lymph nodes (eg, level 12L in the left upper lobe). The other important indication for a 25G needle could be the need to obtain a biop‑sy specimen from a lesion located behind a ves‑sel (transvascular biopsy) or hypervascular tumor (ie, metastatic renal cell carcinoma).Both flexibility and sharpness of 25G needles that allow for more precise puncturing of small or fibrotic (after induction therapy) lymph nodes make them useful also in LC (re)staging. But it is under debate whether the more expensive 25G ProCore histological needles have any advantage over 25G cytological ones in this indication.In conclusion, the endosonography with his‑tological 25G core needles is feasible and safe, so it seems to be a reasonable approach in select‑ed clinical situations for IHC and MT in patients with advanced LC.SuPPLEmEnTARy mATERIALSupplementary material is available with the article at www.mp.pl/paim.ARTICLE InfoRmATIonConfLICT of InTEREST None declared.kinase, and expression of programmed death ligand 1.If the biopsy result was negative or inconclu‑sive, it was repeated with standard 22G cytolog‑ical needles as the confirmatory test.Results From January 2019 to April 2019, 20 patients (13 men [65%] and 7 women [35%]) at a mean (SD) age 68 (6.4) years underwent en‑dosonography. Histological examination was conclusive in 18 patients: small cell lung can‑cer (8 patients), adenocarcinoma (6 patients), squamous cell carcinoma (3 patients), and not otherwise specified (1 patient). Sensitivity, ac‑curacy, and positive predictive value (PPV) for the histology and IHC tests in the whole group were 90%, 90%, 100%, respectively. In 2 samples with false ‑negative results, in which some undif‑ferentiated cancer cells were only found, EBUS‑‑TBNA with a 22G needle confirmed small cell lung cancer (1 patient) and squamous cell carci‑noma (1 patient).The mean (range) size of biopsied lymph nodes was 30.25 mm (17–70 mm). EBUS ‑TBNA was per‑formed in 10 patients with LC, and EUS ‑b‑FNA in 7, as a single procedure. Combined procedure EBUS/EUS ‑b‑NA was used in the next 3 cases. The nodal station 7 was biopsied in 13 patients. Stations 4R, 11L, 4L, 10R, 2R, and 8 were biop‑sied in 8, 5, 4, 3, 2, and 2 patients, respective‑ly. On average, 2 different nodal stations per pa‑tient were biopsied.In 8 of 11 patients with non –small cell lung cancer sensitivity, accuracy, and PPV for endo‑sonography with 25G core needles for MT were 72.7%, 72.7%, 100%, respectively. No complica‑tions after all biopsies were observed.Discussion Endosonography with 25G core nee‑dles in our prospective observational study had high diagnostic yield for histology, IHC, and MT and good safety profile in patients with advanced LC.At present, there is a variety of cytological nee‑dles available for biopsy: thicker 19G, standard 21G and 22G, and thinner 25G.7The EchoTip 25G ProCore needle was designed to provide a histological biopsy material, because it is equipped with a core trap close to its tip (fIguRE 1). It is also 33% more flexible compared fIguRE 1 The 25G ProCore needle endobronchial ultrasound­­guided transbronchial needle aspiration of the mediastinal mass; white arrow points to a window in the needle’s tip.POLISH ARCHIVES OF INTERNAL MEDICINE 2020; 130 (6)552oPEn ACCESS This is an Open Access article distributed under the terms of the Creative Commons Attribution ­NonCommercial ­ShareAlike 4.0 Inter­national License (CC BY ­NC ­SA 4.0), allowing third parties to copy and re­distribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited, distrib­uted under the same license, and used for noncommercial purposes only. For commercial use, please contact the journal office at pamw@mp.pl.How To CITE Misiaszek M, Gnass M, Rudnicka L, et al. Endosonography with 25­gauge core needles for immunohistochemistry and molecular test­ing in lung cancer patients: a feasibility study. Pol Arch Intern Med. 2020; 130: 550­552. doi:10.20452/pamw.15364REfEREnCES1 Planchard D, Popat S, Kerr K, et al. Metastatic non ­small cell lung can­cer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow­­up. Ann Oncol. 2018; 29 (suppl 4): iv192 ­iv237. 2 Vilmann P, Clementsen PF, Colella S, et al. Combined endobronchial and esophageal endosonography for the diagnosis and staging of lung cancer: European Society of Gastrointestinal Endoscopy (ESGE) Guideline, in cooper­ation with the European Respiratory Society (ERS) and the European Society of Thoracic Surgeons (ESTS). Endoscopy. 2015; 47: 545­559. 3 Wahidi MM, Herth F, Yasufuku K, et al. Technical aspects of endobron­chial ultrasound ­guided transbronchial needle aspiration: CHEST guideline and expert panel report. Chest. 2016; 149: 816­835. 4 Babińska A, Berendt ‑Obołończyk M, Śledziński Z, Sworczak K. Liver me­tastasis as the first manifestation of differentiated thyroid cancer. Pol Arch Intern Med. 2018; 128: 478­479.5 Witt BL, Adler DG, Hilden K, et al. A comparative needle study: EUS­­FNA procedures using the HD ProCore(™) and EchoTip(®) 22 ­gauge nee­dle types. Diagn Cytopathol. 2013; 41: 1069­1074. 6 Radzikowska E, Błasińska ‑Przerwa K, Szołkowska M, Wiatr E. A young woman with enlarged hilar and mediastinal lymph nodes. Pol Arch Intern Med. 2019; 129: 824­826.7 Colella S, Scarlata S, Bonifazi M, et al. Biopsy needles for mediastinal lymph node sampling by endosonography: current knowledge and future perspectives. J Thorac Dis. 2018; 10: 6960­6968. 8 Dincer HE, Andrade R, Zamora F, Podgaetz E. A new needle on the block: EchoTip ProCore endobronchial ultrasound needle. Med Devices (Auckl). 2016; 9: 467­473. 9 Mathew R, Shah C, del Mar Cirino ­Marcano M, Stoy S. Endobronchial ultrasound guided transbronchial needle aspiration: core vs traditional nee­dle tissue acquisition in the age of cytogenetics. Chest. 2015; 148: 827A. 10 Di Felice C, Young B, Matta M. Comparison of specimen adequacy and diagnostic accuracy of a 25 ­gauge and 22 ­gauge needle in endobronchi­al ultrasound ­guided transbronchial needle aspiration. J Thorac Dis. 2019; 11: 3643­3649. 11 Stoy SP, Segal JP, Mueller J, et al. Feasibility of endobronchial ultrasound ­guided transbronchial needle aspiration cytology specimens for next generation sequencing in non ­small ­cell lung cancer. Clin Lung Cancer. 2018; 19: 230­238. 12 Yang L, Gu Y, Wang H, et al. Novel ProCore 25 ­gauge needle for en­dobronchial ultrasound ­guided transbronchial needle aspiration reduces the puncture time and frequency, with comparable diagnostic rate for me­diastinal and hilar lymphadenopathy. Thorac Cancer. 2020; 11: 748­753. 

Endosonography with 25-gauge core needles for immunohistochemistry and molecular testing in lung cancer patients : a feasibility study

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Endosonography with 25-gauge core needles for immunohistochemistry and molecular testing in lung cancer patients : a feasibility study

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