The Ability to Look: Management of Breast Disease in the Democratic Republic of the Congo Using Smart Ultrasound Technology.

BACKGROUND: The vast majority of women with breast cancer in sub-Saharan Africa present with advanced stage disease, due primarily to the lack of opportunities for early detection and treatment. As part of a larger effort to increase access to diagnostic and therapeutic services for women's cancers in the Democratic Republic of Congo (DRC), we implemented a curriculum to train the local workforce and a program to build the supportive infrastructure for the diagnosis and treatment of breast cancer at a private sector health facility (Biamba Marie Mutombo Hospital) in Kinshasa. STUDY DESIGN: After onsite trainings in the DRC by a US breast surgeon (RT), Congolese surgeons, general physicians, physician assistants, and nurses used the Phillips Lumify smart-phone ultrasound device to perform and interpret the results of whole breast ultrasound on symptomatic women. Surgeons were trained to perform ultrasound-guided core needle biopsy on those who met the criteria for tissue diagnosis, after which they trained nurses to do the same. RESULTS: Over 3 years, 5,211 patients were identified as having a breast abnormality on clinical breast examination. Ultrasound abnormalities were noted in 1,493 (27%) patients, of which 632 (42%) met the criteria for ultrasound-guided core needle biopsy or fine needle aspiration. Pathology reports were available on 368 (58%) patients who underwent biopsy, of which 164 were malignant and 204 benign. CONCLUSIONS: We demonstrated how the "ability to look" using smart technology can be successfully used to augment clinical breast exam and triage patients for biopsy in a resource-constrained African setting.

[Usefulness of endoscopic ultrasound guided elastography in the assessment of solid pancreatic lesions]. / Utilidad de la elastografía guiada por ultrasonografía endoscópica en la evaluación de lesiones sólidas pancreáticas.

INTRODUCTION: endoscopic ultrasonography (EUS) elastography is considered a useful tool for the evaluation of solid pancreatic lesions (SPL). OBJECTIVE: The aim of our study was to evaluate the diagnostic performance of elastography in patients with SPL. MATERIAL AND METHODS: A prospective, cross-sectional study was performed at the Rebagliati Hospital between July 2017 and June 2018. Patients with a diagnosis of SPL and echoendoscopic study, elastography and FNA were included. Qualitative and quantitative elastography: strain ratio (SR) and strain histogram, were performed and analyzed with histopathological results. The diagnostic accuracy of EUS elastography in detecting malignancy was calculated using receiver operating curve analysis. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy for the detection of malignancy were calculated. RESULTS: Out of 832 EUS examinations performed, 46 patients with SPL (mean age, 64.6 years; 29 women) were included in the study. Pancreatic adenocarcinoma was diagnosed in 36 cases. In qualitative elastography, score 3 was most frequent (n = 39, 84.8%) with sensitivity, specificity and accuracy of 88.9%, 30% and 76.1%, respectively, for predict adenocarcinoma. A strain ratio of 15 or higher (100% sensitivity, 66.7% specificity and 97.8% accuracy) and a histogram of less than 49 (66.7% sensitivity, 97.6% specificity and 95.6% accuracy) predicts malignancy in SPL, with area under a ROC curve of 0.941 (95% CI, 0.82 - 1.0). CONCLUSIONS: EUS elastography provides information to predict the malignant nature of the pancreatic lesion. In our study, the elastographic detection of a score 3, SR≥15 or a histogram <49 predicts the presence of malignancy in LSP.

Needle Biopsy Adequacy in the Era of Precision Medicine and Value-Based Health Care.

CONTEXT.­: Needle biopsy of diseased tissue is an essential diagnostic tool that is becoming even more important as precision medicine develops. However, the capability of this modality to efficiently provide samples adequate for diagnostic and prognostic analysis remains quite limited relative to current diagnostic needs. For physicians and patients, inadequate biopsy frequently leads to diagnostic delay, procedure duplication, or insufficient information about tumor biology leading to delay in treatment; for health systems, this results in substantial incremental costs and inefficient use of scarce specialized diagnostic resources. OBJECTIVE.­: To review current needle biopsy technology, devices, and practice with a perspective to identify current limitations and opportunities for improvement in the context of advancing precision medicine. DATA SOURCES.­: PubMed searches of fine-needle aspiration and core needle biopsy devices and similar technologies were made generally, by tissue site, and by adequacy as well as by health economics of these technologies. CONCLUSIONS.­: Needle biopsy adequacy can be improved by recognizing the importance of this diagnostic tool by promoting common criteria for needle biopsy adequacy; by optimizing needle biopsy procedural technique, technologies, clinical practice, professional education, and quality assurance; and by bundling biopsy procedure costs with downstream diagnostic modalities to provide better accountability and incentives to improve the diagnostic process.

Utilidad de la elastografía guiada por ultrasonografía endoscópica en la evaluación de lesiones sólidas pancreáticas / Usefulness of endoscopic ultrasound guided elastography in the assessment of solid pancreatic lesions

Introducción: La elastografía guiada por ultrasonografía endoscópica es considerada una herramienta útil en la evaluación de las lesiones solidas pancreáticas (LSP). Objetivo: El objetivo del estudio fue evaluar el rendimiento diagnóstico de la elastografia en pacientes con LSP. Material y métodos: Se realizó un estudio transversal prospectivo en el hospital Rebagliati durante julio 2017 a junio 2018. Se incluyeron pacientes con diagnóstico de LSP y estudio ecoendoscópico, elastografía y toma de PAAF. Se realizó elastografia cualitativa y elastografia cuantitativa (SR e histograma) y se analizó con resultados histopatológicos para determinar la sensibilidad, especificidad, valor predictivo positivo (VPP), valor predictivo negativo (VPN) y exactitud diagnostica en la detección de malignidad. Resultados: De 846 ecoendoscopías, se estudiaron 46 pacientes con LSP con una edad promedio de 64,6 años, 29 (63%) sexo femenino. El adenocarcinoma pancreático fue diagnosticado en 36 casos (78,3%). En elastografía cualitativa predominó el score 3 (n=39, 84,8%) con una sensibilidad, especificidad y exactitud de 88.9%, 30% y 76,1% respectivamente para predecir adenocarcinoma. Elastografía cuantitativa de SR≥ 15 (sensibilidad 100%, especificidad 66,7% y exactitud 97,8%) y un valor de histograma menor de 49 (sensibilidad 66,7%, especificidad 97,6% y exactitud 95,6%) predice malignidad en una LSP con área bajo de la curva ROC de 0,941 (IC 95%, 0,82 - 1,0). Conclusiones: La elastografía brinda información para predecir la naturaleza maligna de la lesión. En nuestro estudio la detección elastográfica de un score 3, SR≥ 15 o un histograma < 49 predice la presencia de malignidad en la LSP estudiada.

Introduction: endoscopic ultrasonography (EUS) elastography is considered a useful tool for the evaluation of solid pancreatic lesions (SPL). Objective: The aim of our study was to evaluate the diagnostic performance of elastography in patients with SPL. Material and methods: A prospective, cross-sectional study was performed at the Rebagliati Hospital between July 2017 and June 2018. Patients with a diagnosis of SPL and echoendoscopic study, elastography and FNA were included. Qualitative and quantitative elastography: strain ratio (SR) and strain histogram, were performed and analyzed with histopathological results. The diagnostic accuracy of EUS elastography in detecting malignancy was calculated using receiver operating curve analysis. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy for the detection of malignancy were calculated. Results: Out of 832 EUS examinations performed, 46 patients with SPL (mean age, 64.6 years; 29 women) were included in the study. Pancreatic adenocarcinoma was diagnosed in 36 cases. In qualitative elastography, score 3 was most frequent (n = 39, 84.8%) with sensitivity, specificity and accuracy of 88.9%, 30% and 76.1%, respectively, for predict adenocarcinoma. A strain ratio of 15 or higher (100% sensitivity, 66.7% specificity and 97.8% accuracy) and a histogram of less than 49 (66.7% sensitivity, 97.6% specificity and 95.6% accuracy) predicts malignancy in SPL, with area under a ROC curve of 0.941 (95% CI, 0.82 - 1.0). Conclusions: EUS elastography provides information to predict the malignant nature of the pancreatic lesion. In our study, the elastographic detection of a score 3, SR≥15 or a histogram <49 predicts the presence of malignancy in LSP.

A novel simulator model and standardized assessment tools for fine needle aspiration cytology training.

OBJECTIVES: Fine needle aspiration (FNA) is an invaluable diagnostic procedure for evaluation of lesions; however, acquisition of diagnostic material is dependent on the skill of the practitioner. We report a novel patient simulator for teaching the FNA procedure and structured assessment tools for educators and learners. METHODS: We created a novel simulator model for FNA training, employed a standardized teaching module, and assessed procedure utility in medical students. Groups of students completed training using a commercial version of the model, and underwent structured evaluation using an Objective Structured Assessment of Technical Skills (OSATS) form, and the Debriefing Assessment for Simulation in Healthcare (DASH) tool. RESULTS: In the initial phase, 178 students rated the training workshop between valuable and essential (4.2 on a 5-point Likert scale). In the second phase, for students evaluated with the OSATS form, the mean overall score was 33 out of 50 (range 26-43). The areas of weakness for the participants were: (a) compression after the FNA procedure, (b) completion of the informed consent, and (c) correct explanation of the procedure to the patient. For the group of students that completed the DASH questionnaire, the results were: 6.2 (assessment by students) and 6.7 (assessment by instructor) out of a maximum of 7. CONCLUSION: A realistic simulation model, in combination with a standardized training program with formal assessment methods is a valuable tool to teach FNA. We here describe a process for teaching the FNA procedure to interested educators and learners.

Alternativa diagnóstica en los cánceres laríngeos. Punción aspiración con aguja fina transcartilaginosa laríngea. Análisis costo-beneficio / Diagnostic alternative in laryngeal cancers.Transcartilaginous fine needle aspirationbiopsy. Cost-benefitanalysis / Alternativa diagnóstica nos cânceres laríngeos. Punção aspiração com agulha fina transcartilaginosa laríngea. Análise de custo-benefício

El cáncer de laringe es la segunda neoplasia maligna de cabeza y cuello en adultos. Hemos decidido la búsqueda de un método diagnóstico eficaz y eficiente de las tumoraciones laríngeas sospechosas de malignidad. Se realiza la punción aspiración con aguja fina transcartilaginosa laríngea (PAAF TCL) en las lesiones laríngeas de estadios TNM altos (III y IV) como método diagnóstico alternativo a la tradicional biopsia por microcirugía laríngea. Se logra así la optimización de recursos institucionales y el beneficio de los pacientes en función del tratamiento de los mismos.

Laryngeal cancer is the second leading cause ofhead and neck malignant neoplasms in adults. Wedecided to search for effective diagnostic method oflaryngeal tumors suspicious of malignancy. Transcartilaginous Fine Needle Aspiration Biopsy (TF-NAB) is performed in laryngeal lesions of high levelTNM stage (III and IV) as an alternative to traditionalbiopsy by laryngeal microsurgery. It achievesthe optimization of institutional resources and thebenefit of patients according to their treatment.

O câncer de laringe é segunda neoplasia maligna de cabeça e pescoço em adultos. Decidimos buscar um método diagnóstico eficaz e eficiente das tumorações laríngeas com suspeitas de malignidade.Realiza-se a Punção Aspiração com Agulha Fina Transcartilaginosa Laríngea (PAAF TCL) nas lesões laríngeas de estádios TNM altos (III e IV) como método diagnóstico alternativo à tradicional biopsia por microcirurgia laríngea. Obtém-se assim a otimização de recursos institucionais e o benefício dos pacientes em função do seu tratamento.

The use of endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of thyroid lesions.

BACKGROUND: Non-palpable thyroid nodules can be difficult to access by conventional ultrasound-guided fine needle aspiration, particularly when they are intrathoracic. Many of these patients are subject to multiple follow up scans or invasive diagnostic procedures such as mediastinoscopy or surgical resection. We aim to describe the feasibility of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for diagnosis of thyroid lesions. METHODS: All EBUS-TBNA performed at our institutions from February 2010 to February 2013 were screened, and those in which a thyroid biopsy was performed were reviewed. RESULTS: We identified 12 cases of EBUS-TBNA thyroid biopsy. Nine patients had an indication for EBUS in addition to their thyroid lesions. The median age was 64 years (range 44 to 84 years), and 10 patients were male. Median lesion size was 22.5 mm (range, 10 to 43 mm). Five lesions were strictly intrathoracic. All cases were sampled with a 22G needle and rapid on-site cytologic examination. Adequate samples were obtained in all 12 cases. Malignancy was identified in 3 of the 12 patients (metastatic breast adenocarcinoma, large B-cell lymphoma, and metastatic lung adenocarcinoma). The remaining 9 samples were deemed to be benign nodules. Seven of these were confirmed by clinical follow-up (n = 3), biopsies (n = 3), or surgery (n = 1).There were no EBUS-related complications. CONCLUSIONS: EBUS-TBNA might be a safe and effective alternative for sampling thyroid lesions, particularly useful for those located below the thoracic inlet. Further prospective studies are required to compare its diagnostic yield and safety profile with standard techniques.

Convex probe endobronchial ultrasound: pitfalls, training and service issues.

Convex probe endobronchial ultrasound is an evolving technology allowing real-time transbronchial needle aspiration used for lung cancer staging and diagnosis of cancer or unexplained mediastinal or hilar lymphadenopathy. This article focuses on setting up a service, pitfalls and training issues.

Overcoming obstacles to setting up office-based ultrasound for evaluation of thyroid and parathyroid diseases.

Ultrasound is an integral part of the preoperative workup for patients who are being evaluated for thyroid and parathyroid surgery. It helps improve the accuracy of a fine-needle aspiration biopsy and complements other imaging modalities used for planning the extent of surgery. It also allows imaging of vital structures in relation to the thyroid and parathyroid. The compact nature and portability of ultrasound machines in recent years has made it easier for motivated surgeons (head and neck, general, and endocrine surgeons) to incorporate them into their practice. However, successfully setting up such a service needs adequate planning and an understanding of the obstacles that are involved. We aim to discuss these obstacles in detail, with practical suggestions on how to overcome them. This review may serve as a resource when dealing with issues such as purchasing equipment, training, credentialing, billing, documentation, and collaboration. Although these are discussed with respect to surgeons with an interest in endocrine disease, with some modifications they may also apply to any surgeon who uses ultrasound frequently.

Endobronchial ultrasound-guided transbronchial needle aspiration.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive mediastinal staging tool for lung cancer but also a diagnostic tool for mediastinal lesions near the airway. After a brief historic rationale, this article reviews the indications for EBUS-TBNA, provides an overview of practical, training and financial issues; reviews the evidence comparing the mediastinal staging tools and briefly discusses potential future applications. EBUS-TBNA is most commonly used for staging non-small cell lung cancer (NSCLC), but is also used for diagnosis of unexplained mediastinal lymphadenopathy of other causes. For staging before radical treatment, many centres still perform mediastinoscopy and this should be done to confirm negative EBUS-TBNA results in this setting and when the pre-test clinical probability of lung cancer is high. EBUS-TBNA may be used in the future for staging when the mediastinal nodes are normal according to radiological staging and also in re-staging. EBUS-TBNA can be learned with appropriate training and mentorship; it offers numerous advantages over mediastinoscopy; and it is less invasive and can reduce costs by avoiding unnecessary mediastinoscopies in many cases.

An assessment of fine-needle sampling techniques.

INTRODUCTION: Fine-needle cytology sampling, when adequate, is highly sensitive and specific for tissue-type diagnosis, with figures of 94% and 88%, respectively. This study explores the technique of sampling to reduce interoperator variability and ensure maximal tissue yield. MATERIALS AND METHODS: Apple cortical tissue was sampled as a proxy of human lymph node. A total of 200 samples, by four methods, with 50 by each sampling method, were taken using blue venepuncture needles and weighed to assess tissue yield. RESULTS: Results were analysed using one-way analysis of variance and Tukey's HSD test. Comparable yields, by mass, were achieved by both straight lance and coring techniques (P > 0.05). Significantly greater yield was achieved with a multiplanar technique (P < 0.05). CONCLUSIONS: Multiplanar sampling increases mass yield of tissue in fine-needle sampling. Coring appears to have little bearing on yield.

Endobronchial ultrasound guided transbronchial needle aspiration.

Staging for non-small cell lung cancer (NSCLC) requires accurate assessment of the mediastinal lymph nodes which determines treatment and outcome. As radiological staging is limited by its specificity and sensitivity, it is necessary to sample the mediastinal nodes. Traditionally, mediastinoscopy has been used for evaluation of the mediastinum especially when radical treatment is contemplated, although conventional transbronchial needle aspiration (TBNA) has also been used in other situations for staging and diagnostic purposes. Endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) offers a minimally invasive alternative to mediastinoscopy with additional access to the hilar nodes, a better safety profile, and it removes the costs and hazards of theatre time and general anaesthesia with comparable sensitivity, although the negative predictive value of mediastinoscopy (and sample size) is greater. EBUS-TBNA also obtains larger samples than conventional TBNA, has superior performance and theoretically is safer, allowing real-time sampling under direct vision. It can also have predictive value both in sonographic appearance of the nodes and histological characteristics. EBUS-TBNA is therefore indicated for NSCLC staging, diagnosis of lung cancer when there is no endobronchial lesion, and diagnosis of both benign (especially tuberculosis and sarcoidosis) and malignant mediastinal lesions. The procedure is different than for flexible bronchoscopy, takes longer, and requires more training. EBUS-TBNA is more expensive than conventional TBNA but can save costs by reducing the number of more costly mediastinoscopies. Revenue based tariff systems have been slow to reflect the innovation of techniques such as EBUS-TBNA. In the future, endobronchial ultrasound may have applications in airways disease and pulmonary vascular disease.

Fine-needle aspiration cytology of thyroid nodule: does the needle matter?

OBJECTIVES: Ultrasound-guided fine needle aspiration cytology (US-FNAC) represents the most effective test available to distinguish between benign and malignant thyroid nodules. The major limit is the rate of inadequate specimens which generates a much higher cost. The aim of the present study was to evaluate whether the adoption of stylet needles may result in a significant improvement of diagnostic performance in a large, unselected series of nodules. METHODS: 1468 nodules were submitted to US-FNAC by two different 25-gauge needles: a traditional hollow needle (Ns) or a stylet needle (Ys). Cytological specimens were evaluated in blind conditions by the same cytopathologist. RESULTS: Ys was associated to a significant reduction of non-diagnostic specimens (2.8% vs 9.1% by Ns, respectively, P < 0.001). Logistic regression analysis taking into account sex, age, needle type, nodule size, multiplicity and structure predictor of successful sampling [odds ratio 3.6 (95.0% CN 2.0-6.4), P < 0.001]. The cost analysis comparing the adoption of the two types of needle evidenced that the cost per adequate specimen was consistently less for Ys than for Ns (euro 78.87 vs euro 90.76). CONCLUSION: Our data showed that the adoption of a stylet needle significantly improves diagnostic performance, reducing by about 14% the expenditure per diagnostic procedure. Therefore, we suggest that stylet needles should be widely adopted to perform US-FNAC of thyroid procedures.

[An improved approach in the diagnosis of mediastinal/pulmonary masses through the CT-guided transthoracic fine needle aspiration]. / O abordare eficientizata economic a diagnosticului formatiunilor mediastinopulmonare prin punctie transtoracica ghidata CT.

AIM: In our clinic we have gathered more than 750 cases of CT-guided transthoracic fine needle aspiration (FNA). This procedure is very useful for the diagnosis of mediastinal/pulmonary tumor masses. Because of the relatively high cost of this procedure, we tried to find out a less expensive but still reliable way to get the diagnosis for these tumors, and for this reason we figure out an original approach. METHODS: The study population consisted of 160 patients divided in two groups. To first group we applied the classic method using the conventional needles and the Papanicolaou stain. For the second group we used the spinal anesthetic needle and an original stain (blue--polychrome--tanine--Dragan). The chi2 test was used to match the results and complications between the two groups. RESULTS: This study prove that this original method is as reliable as the classic one but with a ten-fold reduction of costs: 1,198 euro versus 128 euro per 100 smears. CONCLUSIONS: Choosing of this original method for the diagnosis of mediastinal/pulmonary tumors through transthoracic FNA is justified by the low cost, simple technique and the same reliability as the classic method.

Large-core needle biopsy versus fine-needle aspiration biopsy in solid breast lesions: comparison of costs and diagnostic value.

BACKGROUND: In the current climate of budget constraints and personnel shortages, hospitals are required to demonstrate ever-greater cost effectiveness. In the diagnosis of breast lesions, it is useful to compare the costs and benefits of fine-needle aspiration biopsy (FNAB) and core-needle biopsy (CNB). PURPOSE: To determine the total costs of FNAB and CNB of breast lesions, and to compare the costs and diagnostic value of these methods. MATERIAL AND METHODS: The material consisted of 688 breast lesion cases from a Finnish breast-imaging unit. All cases underwent FNAB and/or CNB. Based on the primary biopsy method used, the cases were allocated to the FNAB (n=590) or CNB (n=98) group. Data on costs, sensitivity, and specificity were used to compare the cost effectiveness of the two methods. RESULTS: 590 FNABs were performed in the FNAB group and 98 CNBs in the CNB group. In addition, we needed 78 CNBs in the FNAB group and 11 FNABs in the CNB group for further assessment. The false-negative rate for FNAB was 19% and for CNB 11%; the false-positive rates were 9% and 1%, respectively. The average cost of biopsies per case in the FNAB group was euro 66 and in the CNB group euro 221. FNAB was most expensive when performed under ultrasound guidance (euro 44.65) and CNB when performed under stereotactic guidance (euro 246.37). CONCLUSION: FNAB is a less reliable and less informative diagnostic method than CNB. Although a negative or indeterminate FNAB result requires follow-up or a re-biopsy with core needle, it is still a cost-effective procedure. Stereotactic guidance considerably increases the costs of CNB, and therefore US guidance should be used whenever possible.

Spinal needle improves diagnostic cytological specimens of thyroid nodules.

Ultrasound fine needle aspiration cytology (US-FNAC) represents the most effective test available to distinguish between benign and malignant thyroid nodules, with an accuracy approaching 95%. The major limit of this procedure it is the rate of inadequate specimens which is reported to be from 10% to 31%. Also because cost considerations have always been important and have recently become even more relevant for clinical guidelines in many countries, it is desirable to limit the number of inadequate samples. Recently, we have shown that the use of stylet needles greatly reduces inadequate cytological specimens in thyroid nodules with an intranodular vascular pattern. With the aim to improve our previous results, we have extended our procedure to all thyroid solid nodules. Between February 2004 and March 2006, 312 consecutive patients with thyroid nodule without intranodular vascular pattern at color-Doppler evaluation were enrolled in this prospective study. US-FNAC was performed by two different 25 gauge needles (Neolus [Ns] and Yale Spinal [YS]), and the two procedures were performed in alternate sequence on consecutive patients. Adequate specimens were observed in 145 (92.9%) and 153 (98%) nodules respectively investigated by Ns and in YS (p<0.005). The total cost to obtain a cytological diagnosis by Ns was of euro 12210.2 (156+12 repeated US-FNAC), whereas it was of euro 12449.7 by YS (156+3 repeated US-FNAC). Our data suggest that spinal needles are associated with a low proportion of inadequate FNAC, without increase of total direct cost, considering also the number of FNAC repetitions needed; therefore, their routine use could be taken into account.

Serial biopsies/fine-needle aspirates and their assessment.

Taking a series of repeat biopsies or fine needle aspirates of a tumor during the course of therapy can provide information about treatment-induced changes in tumor biomarkers and help monitor patient response to adjuvant therapy. It is hoped that analysis of biomarkers in serial biopsies will also further our understanding of the molecular mechanisms that determine a tumor's response or resistance to therapy, may facilitate investigation of molecular biology of tumor response, and may provide useful information informing the development of new drugs for breast cancer therapy. In this chapter, practical, clinical considerations in the taking of repeat biopsies are considered and protocols for the taking of fine needle aspirates and core-cut/trucut biopsies are detailed. Their assessment for biomarkers indicative of cellular proliferation, apoptosis, and endocrine response/resistance such as estrogen and progesterone receptor status, HER2 and epidermal growth factor receptor are considered.