Fine-needle aspiration biopsy of thyroid gland

Abstract

FIELD: endocrinology.SUBSTANCE: used for fine-needle aspiration biopsy of the thyroid gland. A 21G 0.6×19 butterfly needle is used, connected via a 30 cm flexible catheter to a 10 ml injection syringe, which is positioned with the cut down. Under ultrasound guidance, the needle is advanced to the node with one hand at an angle of 15–30° until it reaches the node capsule or subcapsular space, where histological material is collected. With the other hand, the syringe plunger is decompressed, aspirating the histological material, and after aspiration is complete, the flexible catheter is disconnected from the injection syringe, the butterfly needle is removed and the histological material is sent for examination.EFFECT: reduction in the number of uninformative results, increase in sampling accuracy, and reduction in the risk of iatrogenic complications, due to the precise positioning of the butterfly needle under ultrasound navigation and controlled aspiration of the material.1 cl, 2 ex

Description

[0001] The invention relates to medicine, more precisely to endocrinology, and can be used to collect test material from thyroid tumors for subsequent cytological examination.

[0002] Ultrasound-guided fine-needle aspiration biopsy (FNAB) is the standard initial procedure for the pathological examination of thyroid nodules.

[0003] However, FNAB has limitations due to the high rate of indeterminate results, including non-diagnostic results (12.9%) and follicular lesions of undetermined significance (9.6%), which requires repeat FNAB and additional determination of malignancy markers [1]. These nodules, defined as (non-diagnostic results / follicular lesions of undetermined significance), are associated with varying malignancy risks ranging from 6% to 30% [2]. Studies have shown that cells located closer to the capsule of the nodule have the highest reliability in such cases [3]. Also, recent scientific data show that malignant thyroid nodules have a thickened capsule with invasion of pathological cells of both the capsule itself and a significant accumulation of them in the subcapsular space. This aspect determines the requirement for increased accuracy of needle localization during FNAB [5].

[0004] A known method of aspiration biopsy of the thyroid gland, adopted as a prototype, includes performing a puncture using a puncture needle under ultrasound control (https: / / uzi-clinic.ru / biopsiya-shchitovidnoy-zhelezy-pod-kontrolem-uzi).

[0005] A disadvantage of this method is the deep perforation of the nodule and the collection of histological material from its central and paracentral regions. This can lead to unreliable results, specifically, the collection of cellular material lacking specific cells, which prevents the cytologist from making an accurate diagnosis. Furthermore, the puncture is performed using a puncture needle located directly on the syringe. With this arrangement, manipulation of the needle and decompression of the syringe plunger, necessary for aspiration of the histological material, are performed with one hand. The physician must support the syringe with the other hand to reduce the risk of damage to surrounding tissue and large vessels. Therefore, the physician holds the syringe with both hands, performing unrelated actions: decompressing the syringe plunger, manipulating the needle attached to the syringe, and supporting the entire device.The intensity of the required aspiration of the material and its volume can vary, making the entire structure less stable relative to the neoplasm (the depth and angle at which the needle approaches the neoplasm constantly change). This technique carries certain risks: significant pain during needle movement, risk of hematoma, dissemination of atypical cells beyond the nodule, and injury to the vocal cords during penetration of the nodule due to the excessive needle length. This aspect requires a reduction in invasiveness and an increase in precision during material collection [4].

[0006] The problem of the claimed invention is the development of a non-traumatic informative method of fine-needle aspiration biopsy of the thyroid gland, ensuring the effective collection of histological material from the capsular and subcapsular space of a nodular neoplasm.

[0007] The technical result is a reduction in the number of uninformative and uncertain results, an increase in the accuracy of collecting material from a thyroid tumor, and a reduction in the risk of iatrogenic complications.

[0008] To achieve the stated technical result in the method of fine-needle aspiration biopsy of the thyroid gland, including puncture of the thyroid gland using a puncture needle under the control of ultrasound equipment, characterized in that a 21G 0.6x19 mm butterfly needle is used as a puncture needle, connected by means of a 30 cm flexible catheter to a 10 ml injection syringe, which is positioned with the cut down and, under ultrasound navigation, is brought to the node with one hand at an angle of 15-30 degrees until it enters the node capsule or subcapsular space, from where histological material is collected, for this purpose, the plunger of the syringe is decompressed with the other hand, aspirating the histological material, and after the end of aspiration, the flexible catheter is disconnected from the injection syringe, the butterfly needle is withdrawn and the histological material is sent for examination.

[0009] The method is carried out as follows.

[0010] A butterfly needle (0.6×19mm, 21G) is connected to a 10ml injection syringe via a 30cm flexible silicone catheter using a Luer-Lock connector. This allows the physician to manipulate the butterfly needle in one hand and the syringe in the other, which allows for aspiration of the histological specimen by decompressing the plunger.

[0011] For a fine-needle aspiration biopsy of the thyroid gland under ultrasound guidance, the patient is placed supine. A 5cm pillow or bolster is placed under the patient's shoulders, with the head tilted back and the chin pointed upward. The patient is prohibited from swallowing during the procedure. The thyroid gland is treated with the antiseptic "Desiptol." This procedure requires two physicians: an ultrasound technician and an endocrinologist. Both physicians are positioned in a sitting position, either side of the patient's neck, depending on the location of the nodule. Using a linear ultrasound transducer with a scanning surface of 3.5-5.0cm and a frequency range of 7.5-14 MHz, the ultrasound technician displays the nodule on the screen and determines its location, size, shape, and structure.The endocrinologist inserts a 21G, 0.6x19 mm butterfly needle, connected to a 10 ml injection syringe via a 30 cm flexible catheter, into the nodule at a 15-30 degree angle, positioning the needle beveled side down. Using an ultrasound machine, the endocrinologist then decompresses the syringe plunger, aspirating the histological material from the nodule. After aspiration is complete, the flexible catheter is disconnected from the syringe, and the butterfly needle is withdrawn. The histological material is then applied to glass slides.

[0012] Compared with the prototype, the claimed invention has the following advantages.

[0013] Using a 21G 0.6x19mm butterfly needle ensures precise placement into the capsule or subcapsular space (deeper placement is impossible due to the short needle length). The excessive length of a standard 40mm injection needle not only risks penetrating the thyroid nodule, damaging deeper structures and tissues, but also reduces precision due to the longer length of the entire device (syringe length + needle length).

[0014] Using a syringe in a separate hand that only performs the function of decompression on the piston increases the accuracy of dosing the required aspiration intensity.

[0015] Anatomically, the thyroid gland is located near major vessels, nerves, the esophagus, and trachea. A flexible 30 cm catheter connecting the butterfly needle and the injection syringe eliminates the risk of accidental needle displacement and damage to underlying tissues and organs by allowing manipulation of the syringe away from the puncture site during aspiration of histological material (the distance between the physician's hands can be varied without risk of dislodging the needle within the thyroid nodule). With a conventional syringe-injection needle arrangement, decompression of the syringe plunger inevitably leads to movement of the entire device and, consequently, the needle tip within the nodule, increasing the risk of nodule penetration and damage, as well as needle tip exit from the nodule. This ultimately leads to the need for repeated puncture, an increased risk of complications, significant discomfort and pain for the patient, and, consequently, a decrease in effectiveness.

[0016] Approaching the node with the needle bevel down and at an angle of 15-30 degrees increases the contact area of ​​the "aspiration window" of the needle bevel with the node material at a limited puncture depth—in the capsular and subcapsular layers—ensuring needle placement in the superficial capsular and subcapsular layers. Aspiration of cellular material from the capsule and subcapsular space of the node allows for precision in this procedure.

[0017] The presence of polypropylene wings on the butterfly needle allows the needle to be fixed in the capsule or subcapsular space of the nodule after it has been inserted, prior to aspiration of the cellular contents. Furthermore, the angle of attack of the butterfly needle on the thyroid nodule is maintained throughout the entire collection procedure. With the classic FNAB technique, the needle inserted into the nodule makes a reciprocating motion with a constantly changing angle of attack. This results in the "aspiration window" simultaneously entering different layers of the nodule. This leads to both a greater risk of complications and a higher rate of false-negative cytological results. The proposed method ensures that the needle remains motionless during aspiration, and the metered aspiration allows for the effective use of a vacuum.

[0018] The presence of a flexible catheter is especially important when the aspiration negative pressure is lost, as it allows you to connect a new syringe and continue aspiration of the contents of the node without the need for re-puncture.

[0019] The luer-lock connection between the syringe and the butterfly needle reduces the risk of system depressurization with loss of vacuum and, consequently, insufficient aspiration force of the unit contents.

[0020] Clinical example 1. Patient D. complained of an enlarged neck, a mass in the left neck area for the last 6 months, and a periodic "lump in the throat." On examination, the thyroid gland is stage II according to WHO, tight-elastic, heterogeneous, a mass up to 3 cm in size, immobile, and painless, is palpable on the left. The submandibular lymph nodes are enlarged. The ultrasound diagnostician displays the nodular mass on the screen using a linear ultrasound transducer with a scanning surface of 3.5-5.0 cm, with a frequency range of 7.5-14 MHz. The entire left lobe is occupied by an isoechoic, heterogeneous, rounded mass with hyperechoic inclusions, uneven contours, a hypoechoic rim, measuring 23.45 * 28.29 * 42.13 mm, peri-intranodular blood flow, increased. A fine-needle aspiration biopsy of a thyroid nodule was performed under ultrasound guidance. The patient is prepared for the procedure.The ultrasound technician stands to the right of the patient's neck, prescribing the puncture biopsy site with an antiseptic, and displays the nodule on the screen. The endocrinologist stands to the left of the patient, in a sitting position. A 21G, 0.6x19 mm butterfly needle is used as the puncture needle. It is connected via a 30 cm flexible catheter to a 10 ml injection syringe, positioned bevel down. The technician inserts the butterfly needle into the nodule with one hand at a 15° angle, visualizing the needle's entry into the nodule capsule. Then, with the other hand, they decompress the syringe plunger, thereby aspirating the nodule's histological material. Aspiration is then stopped, the catheter is disconnected from the syringe, and the butterfly needle is withdrawn. The histological material is then applied to glass slides.Cytological examination revealed: the specimen contained erythrocytes, isolated hemosiderophages, colloid droplets, atypical microfollicular structures, and groups of follicular epithelial cells with signs of proliferation and mild polymorphism. Glandular papillary structures and multinucleated cells were detected in several fields. Stromal elements were also detected. Susp. Papillary carcinoma (TBSRTCV) is suspected. The patient was referred for surgical treatment.

[0021] Clinical example 2. Patient P., born in 1952, consulted an endocrinologist with complaints of a mass up to 4 cm in the left neck area, voice changes over the past 3 months, and discomfort when swallowing. He had lost 7 kg. He has a history of multinodular endemic goiter for over 10 years. An ultrasound technician displays the nodular mass on the screen using a linear ultrasound transducer with a scanning surface of 3.5-5.0 cm and a frequency range of 7.5-14 MHz. A round, isoechoic, heterogeneous mass with hyperechoic inclusions is located in the middle segment of the left lobe of the thyroid gland. The contours are uneven, clear, with a hypoechoic rim, measuring 35.8 * 36.7 * 45.3 mm, with increased perinodular blood flow. A fine-needle aspiration biopsy of a thyroid nodule was performed under ultrasound guidance. The patient is prepped for the procedure. The ultrasound technician, located on the right, cleans the needle biopsy site with antiseptic and displays the nodule on the screen.The endocrinologist is seated on the left. A 21G butterfly needle, 0.6 x 19 mm, is used as a puncture needle. It is connected via a 30 cm flexible catheter to a 10 ml injection syringe, positioned bevel down. With one hand, the physician inserts the butterfly needle into the nodule at a 30° angle, visualizing the needle's entry into the subcapsular space of the nodule. The physician then decompresses the syringe plunger with the other hand, thereby aspirating the histological material from the nodule. Aspiration is then stopped, the catheter is disconnected from the syringe, and the butterfly needle is withdrawn. The histological material is then applied to glass slides. Cytological examination revealed: the material contained erythrocytes, isolated hemosiderophages, dark colloid droplets, atypical microfollicular structures, groups of follicular epithelium with signs of proliferation and accumulation of cells and nuclei, and stromal cells. Follicular neoplasia. TBSRTCIV. There were no complications after the puncture biopsy.Thanks for reading the quotation marks.

[0022] 1 Bongiovanni M, Spitale A, Faquin WC, Mazzucchelli L, Baloch ZW. The Bethesda system for reporting thyroid cytopathology: a meta-analysis. Acta Cytol. 2012;56:333–339. doi: 10.1159 / 000339959.

[0023] 2 Cibas ES, Ali SZ. The 2017 Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2017;27:1341–1346. doi: 10.1089 / thy.2017.0500.

[0024] 3 Karatay E, Javadov M, Kaya H. Thyroid nodule core needle biopsy - current approach. Endocrinol Pol. 2023;74(6). doi: 10.5603 / ep.97053. Epub 2023 Nov 23. PMID:37994586

[0025] 4 [ PubMed ] Park JY, Choi W, Hong AR, Yoon JH, Kim HK, Kang HC. A Comprehensive Assessment of the Harms of Fine-Needle Aspiration Biopsy for Thyroid Nodules: A Systematic Review. Endocrinol Metab (Seoul). 2023 Feb;38(1):104-116. doi: 10.3803 / EnM.2023.1669. Epub 2023 Feb 27.)

[0026] 5 Eftimie LG, Glogojeanu RR, Tejaswee A, Gheorghita P, Stanciu SG, Chirila A, Stanciu GA, Paul A, Hristu R. Differential diagnosis of thyroid nodule capsules using random forest guided selection of image features. Sci Rep. 2022 Dec 14;12(1):21636. doi: 10.1038 / s41598-022-25788-w.

Claims

A method of fine-needle aspiration biopsy of the thyroid gland, including a preliminary ultrasound examination to determine the location and size of a nodular neoplasm, a puncture using a puncture needle under the control of ultrasound equipment, characterized in that a 21G 0.6×19 butterfly needle is used as a puncture needle, connected by a 30 cm flexible catheter to a 10 ml injection syringe, which is positioned with the cut down and, under ultrasound navigation, is brought to the node with one hand at an angle of 15–30° until it enters the capsule of the node or the subcapsular space, from where histological material is collected, for this purpose, the plunger of the syringe is decompressed with the other hand, aspirating the histological material, and after the end of aspiration, the flexible catheter is disconnected from the injection syringe, the butterfly needle is withdrawn and the histological material is sent for examination.