KRAS/GNAS-testing by highly sensitive deep targeted next generation sequencing improves the endoscopic ultrasound-guided workup of suspected mucinous neoplasms of the pancreas.

Pancreatic cysts or dilated pancreatic ducts are often found by cross-sectional imaging, but only mucinous lesions can become malignant. Therefore, distinction between mucinous and non-mucinous lesions is crucial for adequate patient management. We performed a prospective study including targeted next generation sequencing (NGS) of cell-free DNA in the diagnostic endoscopic ultrasound (EUS)-guided workup. Pancreatic cyst(s) or main duct fluid obtained by EUS-guided FNA was analysed by carcinoembryonic antigen (CEA), cytology and deep targeted NGS of 14 known gastrointestinal cancer genes (AKT1, BRAF, CTNNB1, EGFR, ERBB2, FBXW7, GNAS, KRAS, MAP2K1, NRAS, PIK3CA, SMAD4, TP53, APC) with a limit of detection down to variant allele frequency of 0.01%. Results were correlated to histopathology and clinical follow-up. One hundred and thirteen patients with pancreatic cyst(s) and/or a dilated pancreatic main duct (≥5 mm) were screened. Sixty-six patients had to be excluded, mainly due to inoperability or small cyst size (≤10 mm). Forty-seven patients were enrolled for further analysis. A final diagnosis was available in 27 cases including 8 negative controls. In 43/47 (91.5%) of patients a KRAS- and/or GNAS-mutation was diagnosed by NGS. 27.0% of the KRAS-mutated and 10.0% of the GNAS-mutated lesions harbored multiple mutations. KRAS/GNAS-testing by NGS, cytology, and CEA had a sensitivity and specificity of 94.7/100%, 38.1/100%, and 42.1/75.0%, respectively. KRAS/GNAS-testing was significantly superior to CEA (P = .0209) and cytology (P = .0016). In conclusion, KRAS/GNAS-testing by deep targeted NGS is a suitable method to distinguish mucinous from non-mucinous pancreatic lesions, suggesting its usage as a single diagnostic test. Results must be confirmed in a larger cohort.

A Comparative Study of 22G versus 19G Needles for EUS-Guided Biopsies for Parenchymal Liver Disease: Are Thinner Needles Better?

BACKGROUND AND AIMS: Data on comparative efficacy of various available endoscopic ultrasound-guided liver biopsy (EUS-LB) needles are limited. We sought to compare the performance of a novel Franseen-tip 22G fine-needle biopsy (FNB) device to that of 19G needle platforms for liver parenchyma. METHODS: Consecutive patients referred for EUS and suspected to have hepatic parenchymal disease underwent EUS-LB using different EUS needles and were included in this retrospective study. Two blinded expert liver pathologists independently reviewed and reported on: total number of tissue fragments, length of longest fragment, number of complete and incomplete portal tracts (CPT and IPT), and specimen adequacy. RESULTS: A 22G Franseen-tip needle (A) was used in 30 patients; 19G Tru-Cut needle (B) in 50 patients; 19G reverse beveled non-Tru-Cut needle (C) in 27 patients; and a 19G flexible non-Tru-Cut needle (D) in 28 patients. In the order of needles, A, B, C and D, > 10 tissue fragments were obtained in 100%, 6%, 82%, and 96% samples, the mean number of CPTs was 6.9; 3.0; 7.3; and 16.9, length of longest fragment was 3.8, 4. 7, 3.9, and 8.4 mm, and specimen adequacy was 66.7%, 46%, 82.1%, and 81.5%, respectively. A positive correlation was obtained between number of CPTs and length of longest fragment in samples accrued by 19G needles. CONCLUSION: EUS-LB specimens using 22G Franseen-tip needle appear highly fragmented, leading to inferior specimen adequacy compared to 19G non-Tru-Cut needles. We also report on using length of longest fragment as an additional criterion for specimen adequacy as it positively correlates with number of CPTs standard.

Endoscopic Ultrasound-Guided Fine Needle Biopsy Using 22-Gauge Franseen Needle for the Histological Diagnosis of Solid Lesions: A Multicenter Prospective Pilot Study.

BACKGROUND: Recently, a novel 22-gauge needle with three symmetric needle points and crown-shaped cutting heels, known as a Franseen needle, has been developed for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB). AIM: To assess the histological material acquisition rate and histological diagnostic capability of the 22-gauge Franseen needle (AC22) during EUS-FNB for solid lesions. METHODS: This study was designed as an open-label, multicenter, prospective, single-arm pilot study of EUS-FNB using AC22 for the diagnosis of solid lesions. Three passes of FNB using AC22 were performed for all lesions. The primary endpoints were the histological material acquisition rate and histological diagnostic capability. The secondary endpoints were the technical success rate, quality of histological samples, number of passes for diagnosis, and safety. RESULTS: Between September 2017 and May 2018, 75 patients were enrolled. The final diagnoses were malignancy in 65 and benign in 10. Three passes of FNB were technically successful in all patients. The sensitivity, specificity, and accuracy for the malignancy of histological analyses were 92.3% (60/65), 100% (10/10), and 93.3% (70/75), respectively, for the first pass and 95.4% (62/65), 100% (10/10), and 96% (72/75), respectively, for combined three passes. The diagnostic yield plateaued after the second pass. Sufficient tissue samples for histological interpretation were obtained in 96% (72/75) and 100% (75/75) patients for the single pass and combined three passes, respectively. Two patients (2.7%) developed mild pancreatitis as an adverse event. CONCLUSION: EUS-FNB using AC22 showed high histological diagnostic capability with the high first pass yield. CLINICAL TRIALS REGISTRY: UMIN Clinical Trials Registry (UMIN ID: UMIN000036641).

On-site stereomicroscope quality evaluations to estimate white core cutoff lengths using EUS-FNA biopsy sampling with 22-gauge needles.

BACKGROUND AND AIMS: Although rapid on-site cytologic evaluation (ROSE) during EUS-guided FNA biopsy (EUS-FNAB) sampling may improve accuracy of pathologic analyses, cytopathologists are not widely available. We calculated the cutoff lengths required for accurate pathologic diagnoses from stereomicroscopically visible white cores (SVWCs) sampled using 22-gauge needles. METHODS: Overall, 118 patients with mediastinal or upper abdominal solid masses requiring pathologic diagnoses were included. EUS-FNAB sampling was performed using 22-gauge needles. SVWCs were isolated and measured using stereomicroscopy, and the utility of calculated cutoff lengths in diagnosis was investigated. RESULTS: The procedure success and SVWC sampling rates were both 100%, and the median SVWC length was 10 mm. Pathologic examination identified 75, 31, and 12 patients with pancreatic neoplasms (PNs), subepithelial lesions (SELs), and other lesions, respectively. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for diagnosing malignancy using EUS-FNAB sampling were 93.1%, 100%, 100%, 69.6%, and 94%, respectively. The final diagnostic accuracy in the entire cohort, PNs, and SELs was 92.4%, 90.7%, and 93.5%, respectively. Receiver operating characteristic curves demonstrated the overall SVWC cutoff length to be 11 mm (11 mm for PNs, 3.5 mm for SELs). The overall sensitivity according to SVWC cutoff length was 91.4% (87.6% for PNs, 98.8% for SELs). Compared with cutoff length, multivariate analysis confirmed SVWC length to be a stronger independent factor for tissue diagnosis in both groups. CONCLUSIONS: Diagnosis improved significantly with SVWC cutoff lengths ≥11 mm. This may be a useful index for endoscopists, particularly where ROSE is unavailable. (Clinical trial registration number: UMIN000023013.).

Prediction of ultrasound guided fine needle aspiration cytology results by FDG PET-CT for lymph node metastases in head and neck squamous cell carcinoma patients.

INTRODUCTION: Accurate assessment of cervical lymph node status is essential in patients with head and neck squamous cell carcinoma (HNSCC) as it influences prognosis and treatment decisions. During patient workup, lymph node status is often examined by ultrasound guided fine needle aspiration cytology (USgFNAC). 18F-Fluorodeoxyglucose positron emission tomography combined with computed tomography (FDG PET-CT) is frequently used to assess primary tumor and distant metastases but provides information on lymph node status as well. It is possible that FDG PET-CT (if already made for abovementioned indications) can predict the results of USgFNAC in subgroups of lymph nodes based on FDG-uptake and size. The objective of this study is to identify maximum standardized uptake (SUVmax) and short axis diameter cutoff values of lymph nodes at which FDG PET-CT can reliably predict USgFNAC results. METHODS: One hundred and seventeen patients with HNSCC were retrospectively analyzed. Patients were included when FDG PET-CT and USgFNAC were available. SUVmax measurements were performed and compared to the USgFNAC results. RESULTS: Using USgFNAC as a reference standard, the area under the curve of the receiver operating curve was 0.91. At an SUVmax cutoff value of 4.9, the accuracy of FDG PET-CT was the highest (85%). Lymph nodes with short axis diameter ≥1.0 cm and SUVmax ≥4.9 were in 91% positive on USgFNAC. If SUVmax was below 2.2, no nodes were positive on USgFNAC. Of all lymph nodes 52% either had a short axis diameter ≥1.0 cm and SUVmax ≥4.9 or an SUVmax <2.2. FDG PET-CT and USgFNAC results were very similar in these nodes. CONCLUSIONS: By measuring SUVmax values and minimal axial diameters of lymph nodes and using appropriate cutoff values, FDG PET-CT can predict the results of USgFNAC examinations in half of the examined lymph nodes. This information may lead to a reduction of USgFNAC examinations in HNSCC patients if FDG PET-CT is already performed for other indications.

Cytological preparations for molecular analysis: A review of technical procedures, advantages and limitations for referring samples for testing.

Minimally invasive procedures such as endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) must yield not only good quality and quantity of material for morphological assessment, but also an adequate sample for analysis of molecular markers to guide patients to appropriate targeted therapies. In this context, cytopathologists worldwide should be familiar with minimum requirements for refereeing cytological samples for testing. The present manuscript is a review with comprehensive description of the content of the workshop entitled Cytological preparations for molecular analysis: pre-analytical issues for EBUS TBNA, presented at the 40th European Congress of Cytopathology in Liverpool, UK. The present review emphasises the advantages and limitations of different types of cytology substrates used for molecular analysis such as archival smears, liquid-based preparations, archival cytospin preparations and FTA (Flinders Technology Associates) cards, as well as their technical requirements/features. These various types of cytological specimens can be successfully used for an extensive array of molecular studies, but the quality and quantity of extracted nucleic acids rely directly on adequate pre-analytical assessment of those samples. In this setting, cytopathologists must not only be familiar with the different types of specimens and associated technical procedures, but also correctly handle the material provided by minimally invasive procedures, ensuring that there is sufficient amount of material for a precise diagnosis and correct management of the patient through personalised care.

Diagnosis and Management of Small Thyroid Nodules: A Comparative Study with Six Guidelines for Thyroid Nodules.

Purpose To investigate the diagnostic performances of six guidelines used to assess thyroid nodules and to determine whether any of these guidelines identify cancers of aggressive form in this population. Materials and Methods From March 2007 to February 2010, 4696 thyroid nodules that were 1-2 cm in 4585 patients were diagnosed as benign or malignant on the basis of cytopathologic results. Ultrasonographic examinations of the thyroid nodules were retrospectively reviewed and categorized according to the categories defined by six previously published guidelines for thyroid nodules. Diagnostic performances of each guideline for diagnosing thyroid cancer were calculated and compared by using the generalized estimating equation method for logistic regression. Multivariate regression analysis was used to analyze predictors for distant metastasis and recurrence and persistence in patients with small thyroid cancer. Results Of the 4696 thyroid nodules, 3652 (77.8%) were benign and 1044 (22.2%) were malignant. Followed were 873 patients who were diagnosed with small thyroid cancer, of whom 12 had distant metastasis and 66 had recurrence or persistence of disease. Specificity, positive predictive value, and accuracy were highest with criteria developed by Kim et al (83.1%, 59.6%, and 84.0%, respectively), while sensitivity and negative predictive value were highest with Thyroid Imaging Reporting and Data System developed by Kwak et al (98.8% and 98.6%, respectively; P < .001). Positive findings that indicated fine-needle aspiration in the guidelines did not show significant association with distant metastasis or recurrence or persistence (P > .05), but the study power was low to detect a difference. Conclusion With its high specificity and accuracy, criteria from Kim et al may be an effective guideline to use in the management of small thyroid nodules. © RSNA, 2016 Online supplemental material is available for this article.

Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017.

For routine EUS-guided sampling of solid masses and lymph nodes (LNs) ESGE recommends 25G or 22G needles (high quality evidence, strong recommendation); fine needle aspiration (FNA) and fine needle biopsy (FNB) needles are equally recommended (high quality evidence, strong recommendation).When the primary aim of sampling is to obtain a core tissue specimen, ESGE suggests using 19G FNA or FNB needles or 22G FNB needles (low quality evidence, weak recommendation).ESGE recommends using 10-mL syringe suction for EUS-guided sampling of solid masses and LNs with 25G or 22G FNA needles (high quality evidence, strong recommendation) and other types of needles (low quality evidence, weak recommendation). ESGE suggests neutralizing residual negative pressure in the needle before withdrawing the needle from the target lesion (moderate quality evidence, weak recommendation).ESGE does not recommend for or against using the needle stylet for EUS-guided sampling of solid masses and LNs with FNA needles (high quality evidence, strong recommendation) and suggests using the needle stylet for EUS-guided sampling with FNB needles (low quality evidence, weak recommendation).ESGE suggests fanning the needle throughout the lesion when sampling solid masses and LNs (moderate quality evidence, weak recommendation).ESGE equally recommends EUS-guided sampling with or without on-site cytologic evaluation (moderate quality evidence, strong recommendation). When on-site cytologic evaluation is unavailable, ESGE suggests performance of three to four needle passes with an FNA needle or two to three passes with an FNB needle (low quality evidence, weak recommendation).For diagnostic sampling of pancreatic cystic lesions without a solid component, ESGE suggests emptying the cyst with a single pass of a 22G or 19G needle (low quality evidence, weak recommendation). For pancreatic cystic lesions with a solid component, ESGE suggests sampling of the solid component using the same technique as in the case of other solid lesions (low quality evidence, weak recommendation).ESGE does not recommend antibiotic prophylaxis for EUS-guided sampling of solid masses or LNs (low quality evidence, strong recommendation), and suggests antibiotic prophylaxis with fluoroquinolones or beta-lactam antibiotics for EUS-guided sampling of cystic lesions (low quality evidence, weak recommendation). ESGE suggests that evaluation of tissue obtained by EUS-guided sampling should include histologic preparations (e. g., cell blocks and/or formalin-fixed and paraffin-embedded tissue fragments) and should not be limited to smear cytology (low quality evidence, weak recommendation).

[Infection control practices while performing prostate biopsies in France: A CIAFU survey]. / Maîtrise du risque infectieux entourant la réalisation des biopsies de prostate en France : une enquête du Comité d'infectiologie de l'AFU.

In 2008, the French Public Health Committee admitted that associating ultrasound probe protection, and related precautions, and low-level disinfection would be equivalent to the intermediate level disinfection. In 2010, the French Urology Association (AFU) updated guidelines regarding trans-rectal prostate biopsies, namely preventive measures related to cross-transmission of infections. We report an evaluation of compliance to them, driven in 2016 by AFU's infection committee. Although not recommended, almost one third of the urologists still perform biopsies under general anesthesia, and two thirds of them ask for a urine culture before biopsies. Several improvements are still needed: sterilization of needle guide should always be done when not of single use, the ultrasonography gel should be sterile, probes protection should be EC labeled, and compliance to probe processing between two patients should increase. Most of urologists happened to experience blood or feces contamination of probes. Less than half of probes are entirely floodable, and when intermediate level disinfection is done, glutaraldehyde is still referred as disinfectant by one third of the urologists. LEVEL OF EVIDENCE: 4.

EBUS-guided mediastinal lung cancer staging: monitoring of quality standards improves performance.

This audit examined key performance indices related to endobronchial ultrasound (EBUS)-guided mediastinal lung cancer staging before and after the introduction of defined quality standards, at four independent EBUS centres in one cancer network. Data from 642 procedures were prospectively collected and analysed. The introduction of standards was associated with a significant increase (p<0.001) in sampling of key mediastinal lymph node stations (4R, 4L and 7) and a reduction in the variability of staging sensitivity between centres. These data reinforce the requirement for an appropriate regulatory framework for EBUS-transbronchial needle aspiration provision that includes quality assurance and performance monitoring.

Training endosonographers in cytopathology: improving the results of EUS-guided FNA.

BACKGROUND: Although on-site cytopathology services have a significant impact on efficiency and accuracy of EUS-guided FNA (EUS-FNA), the availability of this service is variable. OBJECTIVE: To evaluate the impact of an intensive 2-day training program to educate endosonographers in EUS-related cytopathology. DESIGN: Pilot study. SETTING: Tertiary care medical center. SUBJECTS: Six endosonographers (5 male, median age, 35 years) with minimal previous cytopathology exposure comprised the study cohort. METHODS: Pre- and posttraining testing was administered. Training commenced with a cytopathology tutorial focusing on 4 performance measures: specimen adequacy, sample interpretation, specimen processing, and preliminary diagnosis. Eight live EUS-FNA cases were then performed, and study participants independently completed 4 questions based on performance measures for each case. The ability to independently smear and stain slides and operate a microscope was additionally assessed after a hands-on tutorial. MAIN OUTCOME MEASUREMENTS: Comparison of pretraining and posttraining scores, improvement in performance measures for live cases, and ability to independently handle specimens and operate a microscope. RESULTS: Compared with pretraining, mean posttraining test scores improved by 63% from 48 to 78 out of 100. Mean live case performance score was 95%. Performances improved from 89% on day 1 to 100% on day 2. After training, all endosonographers could independently smear/stain slides and operate a microscope. LIMITATIONS: Long-term impact is unclear. CONCLUSIONS: An intensive 2-day program was effective in training endosonographers in the basics of EUS-related cytopathology. Incorporating basic cytopathology in EUS fellowship curriculum will likely improve diagnostic performance of tissue acquisition procedures.

Diagnostic ability of EUS-FNA for pancreatic solid lesions with conventional 22-gauge needle using the slow pull technique: a prospective study.

OBJECTIVE: Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) using the slow pull technique (SP-FNA) has recently attracted attention as an effective tissue acquisition technique. However, efficacy of SP-FNA with a 22-gauge conventional needle remains unclear. The aim of this study is to evaluate the diagnostic ability of SP-FNA with a 22-gauge needle. MATERIAL AND METHODS: Patients with a pancreatic solid lesion were prospectively enrolled in this study. SP-FNA was performed at two needle passes with a 22-gauge needle. One dedicated pathologist evaluated the obtained samples in terms of quantity (Grade 0: scant; Grade 1: inadequate; Grade 2: adequate), quality (Grade 0: poor; Grade 1: moderate; Grade 2: good), and blood contamination (Grade 0: significant; Grade 1: moderate; Grade 2: low), and provided a pathological diagnosis. Additional EUS-FNA was performed by applying suction (SA-FNA). The evaluation points were as follows: diagnostic accuracy of SP-FNA compared with that of SA-FNA, and the quantity, quality, and blood contamination level of SP-FNA-obtained samples. RESULTS: We enrolled 40 cases. The diagnostic accuracy of SP-FNA was 90% (36/40). There was no significant difference in the accuracy between SP-FNA and SA-FNA (90% vs. 90%, p = 1.000). The samples obtained using SP-FNA were assessed as Grade 2 for quantity in 29 cases (73%), quality in 31 (78%), and blood contamination in 25 (63%). CONCLUSIONS: Adequate, high-quality, and unsubstantially blood-contaminated samples could be obtained using SP-FNA. The diagnostic ability of SP-FNA was 90%, which appeared to be similar to that of SA-FNA.

Endoscopic ultrasound-guided sampling of solid pancreatic masses: 22-gauge aspiration versus 25-gauge biopsy needles.

BACKGROUND: Biopsy needles have recently been developed to obtain both cytological and histological specimens during endoscopic ultrasound (EUS). We conducted this study to compare 22-gauge (G) fine needle aspiration (FNA) needles, which have been the most frequently used, and new 25G fine needle biopsy (FNB) needles for EUS-guided sampling of solid pancreatic masses. METHODS: We conducted a retrospective cohort study of all EUS-guided sampling performed between June 2010 and October 2013. During the study period, 76 patients with pancreatic masses underwent EUS-guided sampling with a 22G FNA needle (n = 38) or a 25G FNB needle (n = 38) for diagnosis. An on-site cytopathologist was not present during the procedure. Technical success, the number of needle passes, cytological diagnostic accuracy, cytological sample quality (conventional smear and liquid-based preparation), histological diagnostic accuracy, and complications were reviewed and compared. RESULTS: There were no significant differences in technical success (100% for both), the mean number of needle passes (5.05 vs. 5.55, P = 0.132), or complications (0% for both) between the 22G FNA group and the 25G FNB group. The 22G FNA and 25G FNB groups exhibited comparable outcomes with respect to cytological diagnostic accuracy (97.4% vs. 89.5%, P = 0.358) and histological diagnostic accuracy (34.2% vs. 52.6%, P = 0.105). In the cytological sample quality analysis, the 25G FNB group exhibited higher scores for the amount of diagnostic cellular material present (22G FNA: 0.92 vs. 25G FNB: 1.32, P = 0.030) and the retention of appropriate architecture (22G FNA: 0.97 vs. 25G FNB: 1.42, P = 0.010) in the liquid-based preparation. The 25G FNB group showed a better histological diagnostic yield for specific tumor discrimination compared with the 22G FNA group (60 % vs. 32.4%, P = 0.018). CONCLUSIONS: Use of the 25G FNB needle was technically feasible, safe, efficient, and comparable to use of the standard 22G FNA needle in patients with solid pancreatic masses in the absence of an on-site cytopathologist. The cytological sample quality in the liquid-based preparation and the histological diagnostic yield for specific tumor discrimination of EUS-guided sampling using a 25G FNB needle were significantly higher than those using a 22G FNA needle.

An expanded training program for endosonographers improved self-diagnosed accuracy of endoscopic ultrasound-guided fine-needle aspiration cytology of the pancreas.

OBJECTIVE: Rapid on-site evaluation (ROSE) of cytologic adequacy improves the diagnostic yield of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). However, on-site advice from a cytotechnologist or cytopathologist is not always available during EUS-FNA. To enhance endosonographers' ability to assess the adequacy of EUS-FNA specimens, we designed an intensive, 2-h interactive training program. The aim of this study was to determine the usefulness of the program. METHODS: Four cytological pictures were selected by a trained cytotechnologist and board-certified cytopathologist from each of the seven patients who underwent EUS-FNA for pancreatic mass in Okayama University Hospital. In total, 28 pictures were used in this study. Twenty endosonographers and 14 cytologists with different levels of EUS-FNA experience evaluated cytological pictures independently before and after the training program. RESULTS: Endosonographers' skill in evaluating the adequacy of EUS-FNA specimens was significantly improved after the completion of the training program (p < 0.001). In contrast, almost all cytologists correctly judged the adequacy of the specimens before taking the training program. CONCLUSIONS: This intensive, 2-h interactive training program is useful for endosonographers and capable of improving ROSE of EUS-FNA specimens.

Applying the Society of Radiologists in Ultrasound recommendations for fine-needle aspiration of thyroid nodules: effect on workup and malignancy detection.

OBJECTIVE: The Society of Radiologists in Ultrasound (SRU) recommendations on thyroid nodules are intended to "diagnose thyroid cancers that have reached clinical significance, while avoiding unnecessary tests and surgery in patients with benign nodules." The aim of our study was to determine the proportion of thyroid nodules undergoing ultrasound-guided fine-needle aspiration (FNA) that do not meet SRU recommendations. MATERIALS AND METHODS: This study is a retrospective study of 400 consecutive ultrasound-guided thyroid FNA encounters from July 2010 through June 2011. An encounter was defined as presentation to the department of radiology on a given date for FNA of one or more thyroid nodules. The criteria for performing biopsy of a nodule were determined by the referring clinicians. Nodules were categorized on the basis of sonographic findings as meeting SRU recommendations for biopsy, which we refer to as "SRU-positive," or not, which we refer to as "SRU-negative." Patients without a definitive pathology diagnosis of Bethesda class benign or malignant nodules were excluded. The characteristics of malignancies were compared for SRU-positive and SRU-negative encounters. RESULTS: The final study group consisted of 360 biopsy encounters for 350 patients and 29 malignancies (8%). Of the 360 biopsy encounters, 86 (24%) were SRU-negative encounters. Malignancy rates in SRU-positive and SRU-negative encounters were 9% (24/274) and 6% (5/86), respectively, and were not significantly different (p=0.5). Eighteen malignancies (75%) in the SRU-positive group were localized, whereas the others had nodal metastases (4/24) or distant metastases (2/24). SRU-positive encounters included medullary carcinoma, anaplastic carcinoma, and melanoma metastasis in addition to papillary carcinoma. All SRU-negative malignancies were localized papillary carcinomas. CONCLUSION: One in four thyroid biopsy encounters at our institution did not meet SRU recommendations for biopsy. The application of SRU recommendations reduces the number of benign nodules that undergo workup. Potentially missed malignancies in SRU-negative nodules are less aggressive by histologic type and stage compared with SRU-positive malignancies.

Comparison of the outcomes of endoscopic ultrasound based on community hospital versus tertiary academic center settings.

OBJECTIVE: Endoscopic ultrasound (EUS) is an established tool in the management of gastrointestinal diseases. The majority of EUS procedures are performed in tertiary care hospitals but the technology has also disseminated to community hospitals. The data from community hospitals are limited and there are no published studies comparing EUS-fine needle aspiration (FNA) outcomes in community versus tertiary settings. Our objective is to compare EUS procedures performed in these two separate settings. METHODS: EUS procedures performed for pancreatobiliary indications in an academic tertiary care hospital and a community hospital were retrospectively reviewed and compared. The patient demographics, procedure time, procedure indications, FNA performed, pass counts, needle size, rapid onsite evaluation (ROSE) and final cytological diagnosis were compared between the two centers. Cytological diagnosis was categorized as satisfactory and unsatisfactory samples. RESULTS: There was no significant difference in patient age, gender, indications, procedure time, FNA performed, needle size, or pass counts between the tertiary hospital (n = 361) and community hospital (n = 119). ROSE was a significant determinant factor for adequacy of sample. There was a positive linear relationship between adequacy of the sample and number of pass counts. After performing a logistic regression and adjusting for target site, the overall odds of having an unsatisfactory specimen were not significantly different at the two centers (OR 0.51, CI 0.23-1.17, p = 0.11). Percentages of unsatisfactory samples were not significantly different at the two centers for solid lesions (7.4 vs. 3.1%, p = 0.33), cysts (33.3 vs. 23.8%, p = 0.31,) or lymph nodes (25.0 vs. 0%, p = 0.063). CONCLUSION: Cytological yield of EUS-FNA in a community hospital is similar to that of a tertiary hospital. Community hospitals can provide EUS services with reasonable success.

Using quality indicators to assess performance of endobronchial ultrasound in the staging and diagnosis of lung cancer: a pre/post study at a New Zealand centre.

AIM: There are no data on the performance of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in the staging and diagnosis of lung cancer in New Zealand. We aimed to assess the performance of EBUS-TBNA for lung cancer staging and diagnosis at our institution before and after the commencement of regular performance monitoring with comparison to published EBUS quality indicators. METHODS: The performance of EBUS-TBNA in the staging and diagnosis of lung cancer was assessed in two phases. Phase 1 consisted of a retrospective review of all lung cancer EBUS performed over a 2-year period. Published quality indicators were determined from the literature with relevant indicators being extracted and used to determine EBUS performance. Local reporting and education were undertaken and prospective data collection was commenced. Phase 2 consisted of prospective assessment of all lung cancer EBUS over the subsequent year. Performance of EBUS was then compared between phases 1 and 2 in order to determine the effect of performance monitoring and identify areas for service improvement. RESULTS: A total of 115 staging EBUS and 117 diagnostic EBUS were performed during the study period. Staging EBUS demonstrated good performance across phases 1 and 2 with high sensitivity and negative predictive values (NPV) for the detection of N2/3 disease, meeting published quality standards. During phase 2 there was evidence of a transition towards more guideline-concordant practice evidenced by more detailed nodal sampling during staging EBUS; however, this did not affect overall sensitivity or NPV. Diagnostic EBUS resulted in high rates of pathological confirmation meeting published quality standards across both phases. Pathway times were similar between phases 1 and 2, with reporting of molecular profiling being the predominant factor in delayed pathway times. CONCLUSION: Monitoring and reporting of local performance allows critical assessment of practice and can identify areas for quality improvement. This review demonstrated good overall performance but prompted a move towards more guideline-concordant practice with increased mediastinal nodal sampling during staging procedures. Consideration should be given to the adoption of routine EBUS performance monitoring within local and/or regional networks, which could be incorporated alongside the newly proposed Lung Cancer Clinical Quality Registry.

A novel flexible cryoprobe for EUS-guided pancreatic biopsies.

BACKGROUND: EUS-guided FNA (EUS-FNA) is an established technique for the cytologic diagnosis of pancreatic disease. Attempts to obtain adequate histologic specimens have yielded variable and mostly insufficient results. OBJECTIVE: To evaluate the safety, feasibility, and quality of histologic biopsy specimens obtained by using a new cryobiopsy probe and to compare them with standard EUS-FNA and (laparoscopic) trucut biopsy specimens of pancreatic tissue. DESIGN: Animal non-survival study. INTERVENTION: Eighty-four pancreatic biopsy specimens (12 per group) were obtained in 4 anesthetized pigs by using one of the following the 18-gauge flexible cryoprobe; a conventional, 19-gauge, EUS-FNA needle; or a rigid, trucut biopsy device (18 gauge). The latter, used in laparoscopic surgery, was considered as the criterion standard for obtaining histology specimens. MAIN OUTCOME MEASUREMENTS: Specimens were evaluated for artifacts and specimen quality by a blinded pathologist who used a 7-point Likert scale to assess histologic adequacy. Biopsy size and bleeding time after biopsy also were recorded. RESULTS: The new cryoprobe was equivalent to the rigid, trucut needle and superior (P < .001) to the conventional 19-gauge FNA needles with respect to artifacts, quality of the specimen, biopsy specimen size, and bleeding. LIMITATIONS: Animal model. CONCLUSION: EUS-guided cryobiopsy was associated with better specimen quality for histologic analysis and a shorter bleeding time compared with a conventional 19-gauge FNA needle in the animal model. It is a promising new technique for histologic examination of pancreatic tissue.

Endobronchial ultrasound-guided transbronchial biopsy of peripheral pulmonary lesions: how many specimens are necessary?

BACKGROUND: Although endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) has been shown to increase the diagnostic yield over conventional bronchoscopic techniques, an important issue regarding the optimal number of biopsy specimens required has not been thoroughly investigated. OBJECTIVES: We sought to examine whether the number of biopsy specimens taken was associated with the diagnostic yield of EBUS-guided TBB and, if this was the case, to determine the optimal number of specimens required for the maximum diagnostic yield in peripheral pulmonary lesions. METHODS: The medical records of patients undergoing EBUS-guided TBB for the diagnosis of peripheral pulmonary lesions from 2008 to 2010 were retrospectively reviewed. The association of clinical and radiological features, including the number of biopsy specimens, with the diagnostic yield was analysed. RESULTS: A total of 384 patients were included for analysis. The overall diagnostic yield of EBUS-guided TBB was 73%, and the only factor influencing the diagnostic yield was the position of the probe. Patients in which the EBUS probe was placed within the lesions had a significantly higher yield (85%) than those in which the probe was adjacent to or outside the lesions (38%; p < 0.001). When the number of biopsy specimens was determined based on their adequacy, it was an insignificant factor in predicting the diagnostic yield. CONCLUSIONS: Probe position independently predicts the diagnostic yield of EBUS-guided TBB. In real-world practice, the optimal number of biopsy specimens should be decided on a case-by-case basis.