Utility of GATA-3 immunocytochemistry for the assessment of fine-needle aspiration in breast cancer patients with suspicious axillary lymph nodes at ultrasound.

BACKGROUND: Ultrasound-guided fine-needle aspiration cytology (FNAC) is a routine preoperative method for evaluating suspicious axillary lymph nodes (ALNs) in patients with breast cancer. However, a range of reasons such as morphological pitfalls, technical artifacts, and sampling errors restrict the sensitivity and accuracy of FNAC. This retrospective study investigated the diagnostic value of GATA-binding protein 3 (GATA-3) immunocytochemistry for FNAC. METHODS: Breast cancer patients who underwent preoperative FNAC for suspicious ALNs, relevant GATA-3 immunocytochemistry, and postoperative status of ALNs were reviewed from the period of March 2020 to February 2022. Altogether, 102 patients were included in the study. FNAC material smears stained with hematoxylin and eosin was initially assessed by two cytopathologists and categorized into five groups: nondiagnostic, negative, atypical, suspicious, and positive for malignancy. Only group of cells positive for malignancy was considered positive. For each case, two selected slides were digitized (whole slide imaged) at ×40 magnification and decolored for GATA-3 immunocytochemistry. The expression of GATA-3 was scored ranging from 0 to 9 (Score ≥3: Positive, Score ≤2: Negative). If either FNAC or GATA-3 immunocytochemistry was positive or the combined test positive, then the case was considered positive. The sensitivity, specificity, and accuracy of FNAC, GATA-3 immunocytochemistry, and combined FNAC/GATA-3 immunocytochemistry were analyzed by χ2 and Fisher's tests. RESULTS: The mean age of the study participants was 50.62 (ranging: 30-73 years). Invasive breast carcinoma (not otherwise specified) accounted for most histological subtypes, and grade 2 was the leading Nottingham grade. Sixteen cases directly underwent mastectomy while the other 86 patients had neoadjuvant therapy. A more serious diagnosis was made based on GATA-3 detection in 22.5% (n = 23) of 102 cases. Of the 23 cases, metastasis was confirmed by GATA-3 detection in 21 cases, and an uncertain diagnosis was ascertained based on GATA-3 immunocytochemistry in 2 with nondiagnostic FNAC results. The sensitivity (77/87, 88.5%) of GATA-3 detection for distinguishing malignancies from benign lesions was higher than that of FNAC alone (62/87, 71.3%) (p < .05). CONCLUSIONS: GATA-3 immunocytochemistry exhibited high diagnostic efficacy in distinguishing malignant breast cancer cells. Moreover, combined FNAC and GATA-3 immunocytochemistry achieved optimal results in terms of reducing the false-negative rate and promoting accuracy.

Comparison of low-cost phantoms for ultrasound-guided fine-needle aspiration biopsy training.

INTRODUCTION: Phantoms and simulators are widely accepted methods to gain valuable experience and confidence for inexperienced trainees prior to seeing their patient and for refining their skills. A phantom model that is durable, simple, and inexpensive to produce and use would be ideal to train practitioners in ultrasound-guided fine-needle aspiration biopsy (USFNA) technique. MATERIALS AND METHODS: In this study, we systematically compared several low-cost phantom models including gelatin, extra firm tofu, canned cooked pork, ballistics gel, and chicken breast for their haptic properties, echogenicity, teaching utility, and overall performance based on a Likert scale (1-5; 5 = best). Nine cytopathologists and cytopathology fellows who perform FNA regularly evaluated these models and completed the survey. RESULTS: The gelatin phantom, with a gelatin to water ratio of 1:8 by weight, was found to be the best for USFNA practice and overall performance, followed by the 1:10 gelatin phantom. Tofu and chicken breast phantoms were also good low-cost alternatives that needed only a few minutes of total preparation time. CONCLUSIONS: Low-cost, homemade phantoms can serve as excellent alternatives to commercial phantoms for practicing and teaching USFNA.

A Comprehensive Assessment of the Harms of Fine-Needle Aspiration Biopsy for Thyroid Nodules: A Systematic Review.

BACKGRUOUND: There have concerns related with the potential harms of fine-needle aspiration biopsy (FNAB). We aimed to summarize the clinical complications and evaluate the safety of FNAB. METHODS: Studies related with the harms of FNAB were searched on MEDLINE, Embase, Cochrane library, and KoreaMed from 2012 to 2022. Also, studies reviewed in the previous systematic reviews were evaluated. Included clinical complications were postprocedural pain, bleeding events, neurological symptoms, tracheal puncture, infections, post-FNAB thyrotoxicosis, and needle tract implantation of thyroid cancers. RESULTS: Twenty-three cohort studies were included in this review. Nine studies which were related with FNAB-related pain showed that most of the subjects had no or mild discomfort. The 0% to 6.4% of the patients had hematoma or hemorrhage after FNAB, according to 15 studies. Vasovagal reaction, vocal cord palsy, and tracheal puncture have rarely described in the included studies. Needle tract implantation of thyroid malignancies was described in three studies reporting 0.02% to 0.19% of the incidence rate. CONCLUSION: FNAB is considered to be a safe diagnostic procedure with rare complications, which are mainly minor events. Thorough assessement of the patients' medical condition when deciding to perform FNABs would be advisable to lower potential complications.

High-Suspicion Subcentimeter Thyroid Nodules: Cost Effectiveness of Active Surveillance versus Fine Needle Aspiration.

PURPOSE: To compare the cost-benefit of active surveillance (AS) against immediate fine needle aspiration (FNA) of sonographically suspicious subcentimeter thyroid nodules. MATERIALS AND METHODS: A Markov model was constructed to compare the cost-benefit of 3 strategies from the point of discovery until death: (a) Surveillance of all nodules, (b) Surveillance of nodules with positive cytology, and (c) Surgery of nodules with positive cytology. The reference case was a 40-year-old woman with a sonographically suspicious subcentimeter thyroid nodule. Transition probabilities, costs, and health state utilities were derived from the literature. Sensitivity analyses were performed to evaluate model uncertainty. Willingness-to-pay threshold was set at $100,000/quality-adjusted life year. RESULTS: Surveillance of nodules with positive cytology dominated in the reference scenario and was cost-beneficial over Surveillance of all nodules, independent of the utility of AS. Surveillance of all nodules was cost-beneficial only at a life expectancy of <2.6 years or surveillance duration of <4 years. CONCLUSIONS: While current guidelines recommend AS of sonographically suspicious subcentimeter nodules, the results of this study suggest that immediate FNA (Surveillance of nodules with positive cytology) is more cost-beneficial than AS (Surveillance of all nodules). Patients with positive cytology on FNA may subsequently opt for AS (Surveillance of nodules with positive cytology) or surgery (Surgery of nodules with positive cytology) according to their level of comfort (ie, utility) with AS.

A prospective comparison of ACR-TIRADS and EU-TIRADS in thyroid nodule assessment for FNA-US.

OBJECTIVE: Prospective data on the accuracy of ultrasound (US) classification systems in thyroid nodules are still scarce. The aim of this study is to compare the accuracy of the American College of Radiology Thyroid Imaging Reporting and Data System (ACR-TIRADS) and European (EU)-TIRADS classification systems. DESIGN AND PATIENTS: Consecutive patients with one or more thyroid nodule(s) who underwent fine-needle aspiration (FNA) under ultrasonographic guidance (FNA-US) were prospectively evaluated. MEASUREMENTS: Clinical evaluation and US data were collected. The reference standard used for this study was FNA-US cytology and histopathological diagnosis. RESULTS: A total of 186 thyroid nodules in 166 patients were evaluated, resulting in 168 nodules from 149 patients with conclusive benign or malignant results. Sensitivity, specificity, negative predictive value (NPV) and false negative (FN) were 100.0%, 28.7%, 100.0% and 0.0%, respectively, for ACR-TIRADS; and 90.0%, 19.1%, 96.8% and 9.1% (n = 1), respectively, for EU-TIRADS. The number of unnecessary FNA-US indicated by ACR-TIRADS was lower than EU-TIRADS (71.3% vs. 80.9%, p = .017), and the number of possibly avoided FNA-US was higher (26.7% vs. 17.8%). Using the same threshold of ACR-TIRADS to indicate FNA-US in EU-TIRADS 3 nodules (2.5 cm), there was an improvement in specificity (30.6%) and avoided FNA-US (28.6%). The best performance of both systems was demonstrated when FNA-US would be indicated only in highly suspicious nodules and/or in the presence of lymphadenopathy, with 85.7% and 89.3% of possibly avoided FNA-US for ACR-TIRADS and EU-TIRADS, respectively, without increasing FN. CONCLUSION: Both systems presented high sensitivity, but low specificity in selecting nodules for FNA-US. The use of nodular size for FNA-US selection is questioned.

Assessment of the diagnostic usefulness of liquid-based cytology. The impact of modifications.

The technique of liquid-based cytology (LBC) is of increasing diagnostic value in non-gynecological cytology. The purpose of the present study was to validate modifications to stages of the LBC process and to assess the diagnostic usefulness of the LBC technique. Between May 2021 and January 2022, a total of 484 samples were prepared from routine cytology tests carried out in the Department of Tumor Pathology of The Greater Poland Cancer Center. The material was obtained from fine-needle aspiration biopsies and fluid samples. One hundred cases were selected for the research described in the article. The slides were prepared using the Becton Dickinson Totalys SlidePrep device. Based on the research, it was concluded that predominantly the LBC technique gives better results than a conventional smear because the background, which would otherwise make it difficult to assess preparations, was eliminated. Additionally, in LBC preparations the cellularity was increased, and the cells were arranged in a monolayer system, which improves the image quality. The introduction of modifications to the LBC method facilitated the process of sample preparation, without adversely affecting the quality of the obtained material.

An innovative synthetic support for immunocytochemical assessment of cytologically indeterminate (Bethesda III) thyroid nodules.

Background: Fine needle aspiration (FNA) is the procedure of choice in the evaluation of thyroid nodules. Nodules with indeterminate cytological categories, Bethesda III and IV, pose challenges in clinical practice and are frequently submitted to diagnostic surgery. CytoFoam Core (CFCS) uses an absorbent foam device inserted into the needle hub to collect the cytological sample aspirated during FNA. Specimen is formalin-fixed and paraffin-embedded. Aim of the study: Assessing diagnostic efficacy of CFCS, compared to traditional cytology, in re-evaluating thyroid nodules classified as Bethesda III, using post-surgical histology as reference standard. Method: Retrospective study on 89 patients with a first indeterminate cytological report who were referred to the Department of Endocrinology of Regina Apostolorum Hospital (Albano L. Rome, Italy) for a second FNA. FNA was performed after at least one month under ultrasound guidance with a 23G needle according to the established procedure. During the second procedure, both traditional cytological (TC) smears and a single-pass CFCS specimen were obtained for each patient. On CFCS samples immunocytochemical staining for Galectin-3, HBME-1, and CK-19 was also performed. 51 patients eventually underwent surgery, and their histological diagnoses were compared to the TC and CFCS reports. Four parameters were evaluated: inadequacy rate, rate of persistent indeterminate (Bethesda III and IV) reports, rate of malignancy in persistently indeterminate nodules, and rate of cancer in lesions cytologically classified as malignant. Results: Non-diagnostic samples were 6 (11.8%) in TC vs 3 (5.9%) in CFCS (p=0.4). Persistent indeterminate samples were 31 (60.8%) in TC vs 19 (37.2%) in CFCS (p=0.01). Rate of malignancy in persistently indeterminate nodules was 8/19 (42.1%) in CFCS vs 9/31 (29%) in TC group (p=0.3). Nine/51 (17.6%) samples were classified as benign by TC vs 21/51 (41.2%) samples by CFCS (p<0.01). All nodules resulted benign at post-surgical evaluation. Five/51 (9.8%) samples were classified as suspicious for malignancy/malignant in TC group against 8/51 (15.7%) samples in CFCS (p=0.5). Post-surgical evaluation confirmed malignancy in all these cases. Conclusion: CFCS demonstrated greater diagnostic accuracy than TC in repeat FNA assessment of cytologically indeterminate nodules. CFCS increased the conclusive diagnosis rate and decreased the number of cytologically indeterminate cases.

Battle of the axes: simulation-based assessment of fine needle aspiration biopsies for thyroid nodules.

IMPORTANCE: Ultrasound-guided fine-needle aspiration biopsies (UGFNA) play a crucial role in the diagnosis of thyroid nodules. There are two techniques for performing an UGFNA: short-axis technique and long-axis technique. There is sparsity in the literature regarding the differences between these two techniques. OBJECTIVE: To compare the efficiency between long-axis and short-axis thyroid UGFNA techniques in trainees. Our secondary outcomes were to define the comfort level and learning curves of trainees. DESIGN: A longitudinal prospective cohort study, completed from December 2018 to November 2019, using the Blue Phantom Thyroid Model© for UGFNA. Face and construct validity of the model were verified. Residents completed UGFNA on an assigned nodule using both long-axis and short-axis techniques, the order of which was sequentially allocated. The rate and time to successful biopsy were obtained for both techniques. Biopsy attempts were repeated to establish learning curves. SETTING: Single-center study. PARTICIPANTS: Fourteen Otolaryngology-Head & Neck Surgery residents at the University of Toronto. MAIN OUTCOME MEASURE: Biopsy success and efficiency for novice learners completing UGFNA on a simulated thyroid model using long-axis and short-axis techniques. RESULTS: A trend towards higher odds of successful biopsy using the long-axis technique with no difference in procedure duration was observed (OR = 2.2, p = 0.095, CI = 0.87-5.39). Learning curve graphs appeared heterogenous according to trainee level. Trainees found the long-axis technique easier to perform (10/14, 71%), and the simulator valuable for learning (12/14, 86%). CONCLUSION: Thyroid UGFNA using the long-axis technique may have an increased success rate and is generally favored by trainees for being easier to perform. Thyroid simulators have the potential to increase learner comfort and efficiency with UGFNA.

Assessment of the risk of disease transmission during fine-needle aspiration cytology under ultrasound guidance by visualization of droplet and aerosol formation.

PURPOSE: Fine-needle aspiration cytology (FNAC) under ultrasound guidance is clinically useful, but there is a risk of spreading infection by generating droplets of contaminated fluids during the procedure. Risk assessment to better control infection remains to be established. The aim of this study was to estimate infection risks during FNAC by visualization of droplet production and deposition using a simulation model. METHODS: The simulation comprised a puncture needle, a device for holding the needle, and a fluid specimen containing fluorescent particles as a model. Simulating each step of FNAC (removal of the inner and outer cylinder and transferring the specimen onto a glass slide), the generation and deposition of droplets were visualized using a laser. RESULTS: After removal of the inner cylinder, an aerosol of droplets in the air surrounding the needle was observed. After removal of the outer cylinder, several large droplets precipitating onto the circumjacent surface were observed. From the beginning of transferring the specimen, a large amount of sizeable droplets first moving away and then precipitating was observed, followed by the production of a cluster of fine droplets drifting and spreading through the air. CONCLUSIONS: Here, the generation of droplets at each step of FNAC, precipitation of large droplets onto the circumjacent surface, and drifting and spreading through the air of fine droplets was visualized. These results emphasize the need for precautions to prevent the transmission of infectious agents during FNAC.

Molecular yield and cytomorphologic assessment of fine needle aspiration specimen supernatants.

INTRODUCTION: Cytology samples are frequently relied upon for the diagnosis of advanced cancer such as lung cancer. As the recommendations for solid malignancies biomarker testing continue to expand, it becomes increasingly important to efficiently utilize limited specimens to minimize the need for additional sampling and its associated risks and costs. MATERIALS AND METHODS: We performed molecular testing on fresh or CytoLyt-fixed supernatants derived from fine needle aspirates (FNAs) and compared its performance against the clinical specimen (including formalin-fixed paraffin-embedded cell blocks, residual PreservCyt and fresh samples). Supernatants were assessed for cellularity using Field-stained Cytospin (CS) preparations. RESULTS: There was overall almost perfect agreement (41/45 cases, K = 0.822) and substantial to almost perfect agreement in molecular testing results of clinically actionable variants between fresh (20/23 cases, Κ = 0.742) and CytoLyt-fixed (21/22 cases, Κ = 0.908) and its clinical specimen counterpart. Interestingly, CS examination of the supernatants revealed viable tumor cells. Centrifugation for 1 minute at 300 rpm is optimal for overall or tumor cellularity recovery. Delayed molecular testing after 3, 4 and 7 days at 4 degrees Celsius showed identical molecular results. CONCLUSIONS: We validated the use of supernatants derived from FNA cytology samples as a substrate for molecular testing using next-generation sequencing and other molecular techniques.

Diagnostic accuracy of Thinprep® in cervical lymph node aspiration: Assessment according to the Sydney system.

BACKGROUND: Fine-needle aspiration cytology (FNAC) is a reliable technique that has been used for many years in lymphadenopathy diagnosis. Although conventional smear is the standard approach in FNAC, liquid-based cytology (LBC) is accepted as an alternative method. Reporting standardization is a significant gap in fine-needle aspiration cytology, leading to failure in pathologist-clinician dialog and interobserver variability. In 2020, an expert panel proposed the Sydney system for classifying and reporting lymph node aspiration cytology. This study aimed to evaluate the diagnostic accuracy of LBC in lymph node aspiration cytology under the guidance of the Sydney system. METHODS: Five hundred-four LBC samples were reevaluated and classified according to the Sydney system. Of these, n = 24 were categorized as L1-inadequate/non-diagnostic, n = 283 as L2-benign, n = 36 as L3- atypical cells of undetermined significance/atypical lymphoid cells of uncertain significance (AUS/ALUS), n = 48 as L4-suspicious, and n = 113 as L5-malignant. Four hundred-one samples were histopathologically confirmed. The diagnostic accuracy of LBC and the risk of malignancy for each Sydney category were calculated. RESULTS: The results were as follows: sensitivity 98.97%; specificity 98.60%; positive predictive value 94.80%; negative predictive value 99.29%; and overall diagnostic accuracy 98.75%. The ROM was 16.6% for L1, 0.7% for L2, 88.8% for L3, and 100% for L4 and L5. CONCLUSION: LBC is suitable for use in lymph node aspiration under the guidance of the Sydney system and has high diagnostic accuracy. Future comprehensive studies will increase the applicability of the Sydney system and minimize interobserver variability.

Shear-wave elastography as a tool in the assessment of thyroid nodules.

INTRODUCTION: Shear-wave elastography (SWE) has been shown to be predictive of malignancy in thyroid nodules. OBJECTIVE: To determine, by SWE, the stiffness cutoff point with the highest specificity and sensitivity to detect thyroid nodules that require surgery. METHODS: Cross-sectional study of ultrasonographically-evaluated patients for thyroid nodules over a period of three years; the TI-RADS classification system was used, and nodule stiffness was determined by SWE. Histopathological specimens were classified using the Bethesda system, and the stiffness cutoff point with the highest specificity and sensitivity was obtained using ROC curves. RESULTS: Forty-one percent of the nodules were classified as TI-RADS 5, and 59 %, as TI-RADS 1-4. In TI-RADS 5 nodules, median stiffness of those in Bethesda system IV-VI categories was 35.9 kPa; in nodules with TI-RADS 1-4, 21.6 kPa. In TI-RADS 5 nodules, a cutoff point > 32.5 kPa had a specificity of 75 % and sensitivity of 57 % to detect those requiring surgery; in TI-RADS 1 to 4 nodules, a cutoff point of 21.5 kPa had a specificity of 63 % and sensitivity of 51 %. CONCLUSION: SWE-determined stiffness is useful to detect nodules that require surgical evaluation.

INTRODUCCIÓN: La elastografía por ondas de corte (SWE) ha demostrado ser predictiva de malignidad en nódulos tiroideos. OBJETIVO: Determinar mediante SWE, el punto de corte de la rigidez con mayor especificidad y sensibilidad para detectar nódulos tiroideos que requieren cirugía. MÉTODOS: Estudio transversal de pacientes con nódulos tiroideos evaluados ultrasonográficamente en un periodo de tres años; se empleó la clasificación TI-RADS y mediante SWE se determinó la rigidez de los nódulos. Con el sistema Bethesda se clasificaron las muestras histopatológicas y mediante curva ROC se obtuvo el punto de corte de la rigidez con mayor especificidad y sensibilidad. RESULTADOS: 41 % de los nódulos fue TI-RADS 5 y 59 %, TI-RADS 1-4. En los TI-RADS 5, la mediana de rigidez de los nódulos con categoría IV-VI del sistema Bethesda fue de 35.9 kPa y en los nódulos con TI-RADS 1-4, 21.6 kPa. En los nódulos TI-RADS 5, la rigidez > 32.5 kPa tuvo especificidad de 75 % y sensibilidad de 57 % para detectar los que requieren cirugía; en los TI-RADS 1-4, el valor de corte de 21.5 kPa tuvo especificidad de 63 % y sensibilidad de 51 %. CONCLUSIÓN: La rigidez determinada por SWE es útil para detectar nódulos que requerirán exploración quirúrgica.

Endoscopic ultrasound fine needle biopsy was not more cost-effective than fine-needle aspiration with rapid on-site evaluation in gastrointestinal lesions diagnosis.

BACKGROUND AND AIM: Cost-effectiveness comparison between endoscopic ultrasound (EUS)-guided acquisition techniques by fine-needle aspiration (FNA) and fine needle biopsy (FNB) in gastrointestinal lesions is still scarce. EUS-FNB has been shown to be more cost-effective than EUS-FNA, however, when adding rapid on-site evaluation (ROSE) to EUS-FNA, it is unclear whether EUS-FNB remains more cost-effective. Our aim was to assess cost-efficacy of EUS-FNB as compared to EUS-FNA with ROSE in gastrointestinal lesions. METHOD: All patients who underwent EUS-FNA with ROSE or EUS-FNB at Galilee Medical Center were retrospectively reviewed. Cost-effectiveness analysis was based on the additional EUS sessions needed and on the average cost expenditure to achieve one final pathological diagnosis. RESULTS: Seventy-four cases were included in the final analysis. Of them, 21 patients (28.4%) were in the EUS-FNB group (group A), as compared to 53 patients (71.6%) who underwent EUS-FNA with ROSE (group B). Additional EUS sessions needed to achieve one final pathological diagnosis were needed in 14.3% of group A patients vs 9.4% in group B patients (P = .5). and, the average cost for achieving one final pathological diagnosis was similar in both groups (1226 ± 369$ for group A vs 1158 ± 309.6.7$ for group B, P = .2). Notably, even after analyzing pancreatic and non-pancreatic gastrointestinal lesions separately, there was no cost benefit of EUS-FNB over EUS-FNA with ROSE. CONCLUSIONS: Cost-effectiveness analysis was not different between EUS-FNB vs EUS-FNA with ROSE. Thus, the preference of one modality over the other should be based on availability and local expertise.

Incorporating cytologic adequacy assessment into precision oncology workflow using telepathology: An institutional experience.

BACKGROUND: Tumor sample quality and quantity determine the success of somatic mutation analysis. Thus, a rapid on-site evaluation (ROSE) tumor cytology adequacy assessment was incorporated into the workflow of precision oncology at Weill Cornell Medicine in New York City. Optimal samples were obtained from 68 patients with metastatic cancer. METHODS: Cytopathologists performed ROSE on fine-needle aspirate samples via telepathology, and subsequently core-needle biopsies were obtained. In a retrospective manner, the concordance between adequacy assessment and the success rate of the procedure was evaluated to obtain sufficient tumor tissue for next-generation sequencing (NGS). RESULTS: Out of the 68 procedures, 43 were documented as adequate and 25 were documented as inadequate. The diagnostic yield of adequate procedures was 100%. Adequacy evaluation predicted the success rate of molecular profiling in 40 of 43 procedures (93%; 95% CI, 80.9-98.5 procedures). The success rate of molecular testing was significantly higher in the adequate group: 93% compared with 32% in the inadequate group (P < .0005). Seven procedures that failed to provide quality material for mutational analysis and pathological diagnosis were evaluated as inadequate. Cell block provided sufficient DNA for NGS in 6 cases. In 2 cases, a core biopsy could not be performed; hence, the fine-needle aspirate material confirmed the diagnosis and was used for NGS testing. CONCLUSION: These results support the incorporation of ROSE into the workflow of precision oncology to obtain high-quality tissue samples from metastatic lesions. In addition, NGS testing of concurrent cytology specimens with adequate cellularity can be a surrogate for NGS testing of biopsy specimens.

Fine Needle Biopsy Versus Core Needle Biopsy Combined With/Without Thyroglobulin or BRAF 600E Mutation Assessment for Detecting Cervical Nodal Metastasis of Papillary Thyroid Carcinoma.

Objectives: To analyze the diagnostic benefit of fine needle aspiration biopsy cytology (FNAB-C) and core needle biopsy tissue (CNB-T) with the addition of thyroglobulin (Tg) in the washout of the needle or BRAF V600E mutation assessment in assessing cervical lymph node metastasis (LNM) in papillary thyroid carcinoma. Materials and Methods: A total of 186 lymph nodes were punctured by fine or core needle. The diagnostic performance of FNAB-C and CNB-T with Tg in the washout or BRAF V600E mutation assessment was compared. Results: The optimal cutoff value of FNAB-Tg was 1.0 ng/ml, with an AUC of 0.976. The sensitivity and specificity of FNAB-C in predicting cervical LNM were 97.4% and 71.4%, respectively, and the addition of FNAB-Tg could contribute to a sensitivity of 100% and a specificity of 95%, but the introduction of BRAF V600E mutation assessment was associated with a decreased sensitivity of 96.3% and a decreased specificity of 50.0%. The FNAB-Tg level showed a comparable distribution in malignant lymph nodes with different TgAb statuses, serum TSH levels, and serum Tg levels. The sensitivity and specificity of CNB-T in predicting cervical LNM were 98.9% and 100%, respectively. The addition of CNB-Tg did not alter the diagnostic ability, but the introduction of BRAF V600E mutation assessment obtained the best performance, with a sensitivity of 100% and specificity of 100%. Conclusion: The sensitivity and specificity of FNAB-C could be increased if combined with FNAB-Tg. CNB-T alone could provide satisfactory diagnostic reliability.

Hypothetical acceptability of hospital-based post-mortem pediatric minimally invasive tissue sampling in Malawi: The role of complex social relationships.

BACKGROUND: Child mortality rates remain unacceptably high in low-resource settings. Cause of death (CoD) is often unknown. Minimally invasive tissue sampling (MITS)-using biopsy needles to obtain post-mortem samples-for histopathological and microbiologic investigation is increasingly being promoted to improve child and adult CoD attribution. "MITS in Malawi" is a sub-study of the Childhood Acute Illness & Nutrition (CHAIN) Network, which aims to identify biological and socioeconomic mortality risk factors among young children hospitalized for acute illness or undernutrition. MITS in Malawi employs standard MITS and a novel post-mortem endoscopic intestinal sampling approach to better understand CoD among children with acute illness and/or malnutrition who die during hospitalization. AIM: To understand factors that may impact MITS acceptability and inform introduction of the procedure to ascertain CoD among children with acute illness or malnutrition who die during hospitalization in Malawi. METHODS: We conducted eight focus group discussions with key hospital staff and community members (religious leaders and parents of children under 5) to explore attitudes towards MITS and inform consent processes prior to commencing the MITS in Malawi study. We used thematic content analysis drawing on a conceptual framework developed from emergent themes and MITS acceptability literature. RESULTS: Feelings of power over decision-making within the hospital and household, trust in health systems, and open and respectful health worker communication with parents were important dimensions of MITS acceptability. Other facilitating factors included the potential for MITS to add CoD information to aid sense-making of death and contribute to medical knowledge and new interventions. Potential barriers to acceptability included fears of organ and blood harvesting, disfigurement to the body, and disruption to transportation and burial plans. CONCLUSION: Social relationships and power dynamics within healthcare systems and households are a critical component of MITS acceptability, especially given the sensitivity of death and autopsy.

Elastografía por ondas de corte como herramienta en la evaluación de los nódulos tiroideos / Shear-wave elastography as a tool in the assessment of thyroid nodules

Resumen Introducción: La elastografía por ondas de corte (SWE) ha demostrado ser predictiva de malignidad en nódulos tiroideos. Objetivo: Determinar mediante SWE, el punto de corte de la rigidez con mayor especificidad y sensibilidad para detectar nódulos tiroideos que requieren cirugía. Métodos: Estudio transversal de pacientes con nódulos tiroideos evaluados ultrasonográficamente en un periodo de tres años; se empleó la clasificación TI-RADS y mediante SWE se determinó la rigidez de los nódulos. Con el sistema Bethesda se clasificaron las muestras histopatológicas y mediante curva ROC se obtuvo el punto de corte de la rigidez con mayor especificidad y sensibilidad. Resultados: 41 % de los nódulos fue TI-RADS 5 y 59 %, TI-RADS 1-4. En los TI-RADS 5, la mediana de rigidez de los nódulos con categoría IV-VI del sistema Bethesda fue de 35.9 kPa y en los nódulos con TI-RADS 1-4, 21.6 kPa. En los nódulos TI-RADS 5, la rigidez > 32.5 kPa tuvo especificidad de 75 % y sensibilidad de 57 % para detectar los que requieren cirugía; en los TI-RADS 1-4, el valor de corte de 21.5 kPa tuvo especificidad de 63 % y sensibilidad de 51 %. Conclusión: La rigidez determinada por SWE es útil para detectar nódulos que requerirán exploración quirúrgica.

Abstract Introduction: Shear-wave elastography (SWE) has been shown to be predictive of malignancy in thyroid nodules. Objective: To determine, by SWE, the stiffness cutoff point with the highest specificity and sensitivity to detect thyroid nodules that require surgery. Methods: Cross-sectional study of ultrasonographically-evaluated patients for thyroid nodules over a period of three years; the TI-RADS classification system was used, and nodule stiffness was determined by SWE. Histopathological specimens were classified using the Bethesda system, and the stiffness cutoff point with the highest specificity and sensitivity was obtained using ROC curves. Results: Forty-one percent of the nodules were classified as TI-RADS 5, and 59 %, as TI-RADS 1-4. In TI-RADS 5 nodules, median stiffness of those in Bethesda system IV-VI categories was 35.9 kPa; in nodules with TI-RADS 1-4, 21.6 kPa. In TI-RADS 5 nodules, a cutoff point > 32.5 kPa had a specificity of 75 % and sensitivity of 57 % to detect those requiring surgery; in TI-RADS 1 to 4 nodules, a cutoff point of 21.5 kPa had a specificity of 63 % and sensitivity of 51 %. Conclusion: SWE-determined stiffness is useful to detect nodules that require surgical evaluation.

The Milan System for Reporting Salivary Gland Cytopathology: Assessment of Cytohistological Concordance and Risk of Malignancy.

INTRODUCTION: The Milan System for Reporting Salivary Gland Cytopathology (MSRSGC) was proposed by the American Society of Cytopathology and the International Academy of Cytology to bring uniformity in the reporting system and the treatment protocol. A wide range of risk of malignancy for each category has been reported by various authors by applying the system. AIM: We intend to study the cytohistological concordance and the ROM for each of the diagnostic categories of the Milan system. MATERIALS AND METHODS: The study included 292 cases of fine-needle aspiration cytology (FNAC) of salivary gland lesions over a period of 3 years. The diagnosis of these cases was reclassified into the 6 categories of the Milan system. The cytohistological concordance and ROM for each category of the Milan system were calculated based on the clinical and histopathological follow-up. RESULTS: The patients' age ranged from 3 to 81 years with the mean of 42.65 ± 16.3 years. The cases included 189 (64.7%) parotid, 82 (28.1%) submandibular, and 21 (7.2%) cases of minor salivary gland swellings. Follow-up histopathological diagnosis for 102 cases was available. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were calculated to be 64.28, 97.01, 90, 86.67, and 87.37%, respectively. After reclassification, the number of cases in each category was as follows: category I: 31 (10.62%), category II: 80 (27.4%), category III: 2 (0.68%), category IVA: 143 (48.97%), category IVB: 1 (0.34%), category V: 13 (4.45%), and category VI: 22 (7.53%). The calculated ROM was as follows: category I: 42.86%, category II: 26.67%, category III: 100% category IVA: 10.17%, category IVB: 0%, category V: 71.42%, category VI: 100%. CONCLUSION: FNAC is an excellent procedure to differentiate benign from malignant tumors, and MSRSGC is a useful system for risk assessment and deciding the further treatment protocol. Our findings also suggest that in addition to the surgical follow-up, inclusion of the clinical and radiological follow-up may be a better strategy for calculation of ROM, especially for categories I and II.

Time and Cost of Ultrasound-Guided Fine-Needle Aspiration Biopsy/Core-Needle Biopsy for Primary Laryngohypopharyngeal Squamous Cell Carcinoma.

OBJECTIVES: This study aimed to evaluate benefits in terms of time and cost of percutaneous ultrasound-guided fine-needle aspiration biopsy/core-needle biopsy (US-FNAB/CNB) for the diagnosis of primary laryngeal and hypopharyngeal squamous cell carcinoma (LHSCC) in comparison with direct laryngoscopic biopsy (DLB) under general anesthesia. STUDY DESIGN: Retrospective case-control study. SETTING: Single operator of a single center. SUBJECTS AND METHODS: From 2018 to 2019, 28 patients who underwent percutaneous US-FNAB/CNB for the diagnosis of untreated LHSCC were enrolled. All US-FNAB/CNBs were performed in the outpatient department by a single head and neck surgeon. Their results were compared with those of 27 patients who underwent DLB under general anesthesia. RESULTS: No major complications occurred in the US-FNAB/CNB and DLB groups. Time to biopsy, time to pathologic diagnosis, and time to treatment initiation in the US-FNAB/CNB and DLB groups were 0 and 14 days (P < .001), 7 and 20 days (P < .001), and 24 and 35 days (P = .001), respectively. Procedure-related costs were $368.5 and $981.0 in the US-FNAB/CNB and DLB groups (P < .001). CONCLUSIONS: US-FNAB/CNB offers true benefits in terms of time and cost over those given by conventional DLB for diagnosis of LHSCC in indicated patients.

Impact of the Milan System for Reporting Salivary Gland Cytology on risk assessment when used in routine practice in a real-time setting.

INTRODUCTION: Several retrospective studies across the world have validated the role of the Milan System for Reporting Salivary Gland Cytology (MSRSGC) in improving communication between pathologists and clinicians. In this study, we evaluated the applications of MSRSGC in a real-time setting for 2 years. MATERIALS AND METHODS: All salivary gland lesions that underwent fine-needle aspiration (FNA) from January 2018 to December 2020 were categorized according to MSRSGC guidelines. The risk of malignancy (ROM) was calculated for each category and compared with the ROM proposed by MSRSGC and recent retrospective studies. RESULTS: A total of 160 FNA of salivary gland lesions were categorized as: nondiagnostic (ND) 30 (18%), non-neoplastic (NN) 7 (10.6%), atypia of undetermined significance (AUS) 5 (3.1%), benign neoplasm (BN) 59 (36.8%), salivary gland of uncertain malignant potential (SUMP) 21 (13%), suspicious for malignancy (SM) 3 (1.84%), and malignant (M) 25 (15.6%). Histopathologic follow-up was available for 94 (57.5%) cases. The ROM for each category was ND 54%, NN 0%, AUS 66%, BN 0%, SUMP 37.56%, SM 100%, and M 100%. CONCLUSION: With strict adherence to the diagnostic criteria and MSRSGC guidelines, a ROM of 100% in SM and M categories and a ROM of 0% in NN can be achieved in a real-time setting. The high ROM in the ND category in our study highlights the value of repeat FNA/biopsy for this category. High ROM for AUS indicates the tendency to classify high-grade tumors as AUS, calling for refinement in its criteria.