The factors that influence the diagnostic accuracy and sample adequacy of EUS-guided tissue acquisition for the diagnosis of solid pancreatic lesions.

Background and Objectives: EUS-guided tissue acquisition (EUS-TA) is the preferred method to acquire pancreatic cancer (PC) tissues. The factors associated with false-negative outcomes and inadequate samples should be explored to gain an understanding of EUS-TA. Methods: The patients who underwent EUS-TA for suspected solid PC but whose results were false-negative were analyzed. The PC patients who underwent EUS-TA with true-positive results on the first day of every month during the study period were selected as the control group. The factors influencing diagnostic accuracy and sample adequacy were explored. Results: From November 2017 to January 2022, 184 patients were included in the false-negative group, and 175 patients were included in the control group. Multivariate logistic regression demonstrated that the recent acute pancreatitis [odds ratio (OR): 0.478, 95% confidence interval (CI): 0.250-0.914, P = 0.026] and high echo component within the tumor (OR: 0.103, 95% CI: 0.027-0.400, P = 0.001) were independently associated with false-negative EUS-TA results. Meanwhile, using fine-needle biopsy (FNB) needles (OR: 2.270, 95% CI: 1.277-4.035, P = 0.005), more needle passes (OR: 1.651,95% CI: 1.239-2.199, P = 0.005), large tumor size (OR: 1.053, 95% CI: 1.029-1.077, P < 0.001), and high CA-19-9 level (OR: 1.001, 95% CI: 1.000-1.001, P = 0.019) were independently associated with true-positive EUS-TA outcomes. Three needle passes are needed to achieve optimal EUS-TA outcomes. Tumor location in the body/tail (OR: 1.38, 95% CI: 1.01-1.72; P = 0.04), needle passes ≥3 (OR: 1.90; 95% CI: 1.22-2.56; P < 0.001), and using the FNB needle (OR: 2.10; 95%: 1.48-2.85; P < 0.001) were independently related to sample adequacy. Conclusion: Numerous factors were identified to be associated with the diagnostic accuracy and sample adequacy of EUS-TA.

Endoscopic ultrasound-guided fine needle biopsy using macroscopic on-site evaluation technique reduces the number passes yet maintains a high diagnostic accuracy: A randomized study.

BACKGROUND AND AIM: Although rapid on-site cytological evaluation (ROSE) for endoscopic ultrasound (EUS)-guided tissue acquisition (EUS-TA) may increase diagnostic yield, it is not widely available. Macroscopic on-site evaluation (MOSE) is an alternative modality although it is not standardized for EUS-guided fine-needle biopsy (FNB). We evaluated diagnostic performance of MOSE compared with conventional technique of EUS-TA using core biopsy needle. METHODS: Consecutive patients undergoing EUS-FNA for solid lesions were randomized to MOSE or conventional arms. The primary and secondary outcome measures were diagnostic accuracy, diagnostic yield, sensitivity, specificity, positive and negative predictive values, and the number of passes, respectively. The optimum parameters for macroscopic visible core (MVC, i.e., length, number) by MOSE to achieve accurate diagnosis were evaluated. RESULTS: Ninety-six patients (48 conventional and 48 MOSE) were enrolled. Mean lesion size was larger in MOSE arm (32.67 ± 7.22 vs 29.31 ± 6.98 mm, P = 0.023). Diagnostic accuracy (95.8% vs 91.6%), diagnostic yield (97.9% vs 95.8%), procedure duration, and adverse events of the two methods were similar. Median number of passes with MOSE was less (2 vs 3 P = 0.000). Area under the receiver operating characteristic curve showed that with MOSE, obtaining a total MVC length of 11.5 mm had 93.3% sensitivity, and 2.5 MVC cores (each 4 mm) had 86.7% sensitivity for malignancy diagnosis. CONCLUSIONS: EUS-FNB with MOSE, a simple reliable technique, can achieve a high and comparable diagnostic accuracy with lesser number of passes. Obtaining longer length and greater number of MVC increase the sensitivity to diagnose malignancy with MOSE.

Diagnostic performance of EUS-guided tissue acquisition for solid pancreatic lesions ≤10 mm.

Background and Objectives: EUS tissue acquisition (EUS-TA) is the standard diagnostic method for solid pancreatic lesions (SPLs); however, there are few reports on EUS-TA results for SPLs ≤10 mm. Furthermore, given the recent advent of fine-needle biopsy, the current diagnostic accuracy of EUS-TA for SPLs ≤10 mm is unknown. This study aimed to evaluate the diagnostic accuracy and efficacy of EUS-TA for SPLs ≤10 mm. Methods: We retrospectively analyzed the data of 109 patients with SPLs ≤10 mm who underwent EUS-TA. All patients underwent rapid on-site specimen evaluation. Results: The median tumor diameter was 8 mm (range, 2.5-10 mm), and the technical success rate was 99.1% (108/109). Adverse events were observed in 3 patients (2.8%). The diagnostic performance was as follows: sensitivity, 90.1% (64/71); specificity, 97.3% (36/37); accuracy, 92.6% (100/108); positive predictive value, 98.5% (64/65); and negative predictive value, 83.7% (36/43). Multivariate analysis revealed that the number of punctures (odds ratio, 7.03; 95% confidence interval, 1.32-37.5; P = 0.023) and tumor type (odds ratio, 11.90; 95% confidence interval, 1.38-102.0; P = 0.024) were independent risk factors for inaccurate EUS-TA results. The diagnostic accuracy of EUS-TA for pancreatic ductal adenocarcinoma was 87.5% (14/16). No EUS-TA-related needle-tract seeding was observed in patients with pancreatic ductal adenocarcinoma during the observation period. Conclusions: EUS-TA for SPLs ≤10 mm showed adequate diagnostic accuracy and was safe for use with rapid on-site specimen evaluation in all cases.

Contributions of endoscopic ultrasonography-guided tissue acquisition (EUS-TA) to the diagnostics of biliary stricture and gallbladder lesions.

Endoscopic ultrasonography (EUS) provides high spatial resolution and more detailed images than other diagnostic modalities. Furthermore, EUS-guided tissue acquisition (EUS-TA), such as EUS-guided fine needle aspiration or biopsy (EUS-FNA/FNB), is an indispensable tool in pancreaticobiliary disease diagnostics, supporting a conclusive pathological diagnosis. In this review, we evaluate the current status and the usefulness of EUS-TA for the diagnostics of the following biliary tract diseases: (A) biliary stricture diagnostics, (B) biliary tract cancer (BTC) itself, and (C) staging of advanced BTC. Previous reports have shown that EUS-FNA for biliary lesions is a safe procedure that is useful in differentiating biliary cancer from benign lesions and in the staging of BTC. On the other hand, the diagnostic performance of EUS-TA for bile duct lesions is reported to be similar to that of transpapillary biopsy. Overall, EUS-TA for biliary lesions may be a safe and effective method, but it should be performed with an understanding of the risk of serious adverse events such as bile leakage and peritoneal dissemination of cancer. It is recommended for distal biliary stricture lesions for which endoscopic retrograde cholangiopancreatography cannot confirm the diagnosis or gallbladder lesions if they do not require the needle to pass through the biliary lumen.

Impact of biliary stents in the performance of the EUS-guided tissue acquisition: A systematic review and meta-analysis / Impacto de los stents biliares en el rendimiento de la adquisición de biopsias guiadas por ecoendoscopia: una revisión sistemática y metanálisis

Introduction and aim: Pancreatobiliary tumours are challenging to diagnose exclusively by imaging methods. Although the optimum moment for carrying out the EUS is not well defined, it has been suggested that the presence of biliary stents may interfere with the proper staging of tumours and the acquisition of samples. We performed a meta-analysis to evaluate the impact of biliary stents on EUS-guided tissue acquisition yield. Material and methods: We conducted a systematic review in different databases, such as PubMed, Cochrane, Medline, and OVID Database. A search was made of all studies published up to February 2022. Results: Eight studies were analyzed. A total of 3185 patients were included. The mean age was 66.9±2.7 years; 55.4% were male gender. Overall, 1761 patients (55.3%) underwent EUS guided tissue acquisition (EUS-TA) with stents in situ, whereas 1424 patients (44.7%) underwent EUS-TA without stents. The technical success was similar in both groups (EUS-TA with stents: 88% vs EUS-TA without stents: 88%, OR=0.92 [95% CI 0.55–1.56]). The type of stent, the needle size and the number of the passes were similar in both groups. Conclusions: EUS-TA has similar diagnostic performance and technical success in patients with or without stents. The type of stent (SEMS or plastic) does not seem to influence the diagnostic performance of EUS-TA. Future prospectives and RCT studies are needed to strengthen these conclusions. (AU)

Introducción y objetivo: Los tumores pancreatobiliares son lesiones difíciles de diagnosticar exclusivamente por métodos de imagen. Aunque no está bien definido el momento óptimo para la realización de la ecoendoscopia (EUS), se ha demostrado que la presencia de stents biliares puede interferir en la correcta estadificación de los tumores y la toma de muestras. Realizamos un metanálisis para evaluar el impacto de los stents biliares en el rendimiento de la adquisición de tejido guiada por EUS. Material y métodos: Realizamos una revisión sistemática en diferentes bases de datos, como PubMed, Cochrane, Medline y OVID Database. Se realizó una búsqueda de todos los estudios publicados hasta febrero de 2022. Resultados: Se analizaron 8 estudios. Se incluyeron un total de 3.185 pacientes. La media de edad fue de 66,9±2,7 años; el 55,4% fueron pacientes de sexo masculino. En total, 1.761 pacientes (55,3%) se sometieron a biopsias guiadas por EUS con stents in situ, mientras que 1.424 pacientes (44,7%) se sometieron a dichas biopsias sin stents. El éxito técnico fue similar en ambos grupos (EUS con stents: 88% vs. EUS sin stents: 88%, OR=0,92 [IC 95% 0,55-1,56]). El tipo de stent, el tamaño de la aguja y el número de pases fueron similares en ambos grupos. Conclusiones: La biopsia por EUS tiene un rendimiento diagnóstico y un éxito técnico similares en pacientes con o sin stents. El tipo de stent (SEMS o plástico) no parece influir en el rendimiento diagnóstico de la adquisición de tejido guiada por EUS. Se necesitan futuros estudios prospectivos y estudios aleatorizados controlados para fortalecer estas conclusiones. (AU)

Methotrexate-associated lymphoproliferative disorder: A rare pancreatic tumor diagnosed via endoscopic ultrasound-guided fine-needle biopsy.

A 73-year-old woman with a history of rheumatoid arthritis treated with methotrexate (MTX) for the last 10 years was referred to our hospital for a pancreatic tumor examination. Contrast-enhanced abdominal computed tomography revealed a 20-mm-diameter hypovascular tumor in the pancreatic tail. A hypoechoic mass with heterogeneous internal echo was found on an endoscopic ultrasound (EUS). An EUS-guided fine-needle biopsy (EUS-FNB) was performed with a 22-gauge Franseen-tip needle. Histologic examination of EUS-FNB specimens from the pancreatic tumor revealed the proliferation of atypical spindle cells. Immunohistochemical staining for CD20 and Ki-67 was positive in the atypical cells. Immunohistochemical staining for CD3 was partially positive in the atypical cells. Epstein-Barr virus-encoded RNA in situ hybridization showed positive staining. MTX-related lymphoproliferative disorder (MTX-LPD) with Epstein-Barr virus infection was diagnosed. MTX treatment was immediately discontinued, and treatment was initiated by a hematologist. However, her condition rapidly deteriorated, and she died of multiple organ failure 4 weeks after diagnosis. MTX-LPD can complicate gastrointestinal lesions. However, most lesions are localized in the stomach and rarely complicate pancreatic lesions. MTX-LPD is classified as an "iatrogenic" LPD. Therefore, immediate action, such as MTX discontinuation, is necessary. In conclusion, endoscopists should be aware that MTX-LPD lesions can occur in the pancreas and gastrointestinal tract. Moreover, EUS-FNB can be useful in the diagnosis of this rare pancreatic tumor.

Impact of biliary stents in the performance of the EUS-guided tissue acquisition: A systematic review and meta-analysis.

INTRODUCTION AND AIM: Pancreatobiliary tumours are challenging to diagnose exclusively by imaging methods. Although the optimum moment for carrying out the EUS is not well defined, it has been suggested that the presence of biliary stents may interfere with the proper staging of tumours and the acquisition of samples. We performed a meta-analysis to evaluate the impact of biliary stents on EUS-guided tissue acquisition yield. MATERIAL AND METHODS: We conducted a systematic review in different databases, such as PubMed, Cochrane, Medline, and OVID Database. A search was made of all studies published up to February 2022. RESULTS: Eight studies were analyzed. A total of 3185 patients were included. The mean age was 66.9±2.7 years; 55.4% were male gender. Overall, 1761 patients (55.3%) underwent EUS guided tissue acquisition (EUS-TA) with stents in situ, whereas 1424 patients (44.7%) underwent EUS-TA without stents. The technical success was similar in both groups (EUS-TA with stents: 88% vs EUS-TA without stents: 88%, OR=0.92 [95% CI 0.55-1.56]). The type of stent, the needle size and the number of the passes were similar in both groups. CONCLUSIONS: EUS-TA has similar diagnostic performance and technical success in patients with or without stents. The type of stent (SEMS or plastic) does not seem to influence the diagnostic performance of EUS-TA. Future prospectives and RCT studies are needed to strengthen these conclusions.

Objective evaluation of the resistance forces of 22-gauge EUS-FNA and fine-needle biopsy needles.

Background and Objectives: EUS-guided tissue acquisition is routinely performed for the diagnosis of gastrointestinal tract and adjacent organ lesions. Recently, various types of needles have been developed. However, how the shape of the needle tip and echoendoscope tip angle affect puncturability, has not been clarified. The aim of this experimental study was to compare the puncturability of several 22-gauge EUS-FNA and EUS-guided fine-needle biopsy (EUS-FNB) needles, and to evaluate the effects of the needle tip shape and echoendoscope tip angle on tissue puncturability. Materials and Methods: The following six major FNA and FNB needles were evaluated: SonoTip® ProControl, EZ Shot 3 Plus, Expect™ Standard Handle, SonoTip® TopGain, Acquire™, and SharkCore™. The mean maximum resistance force against needle advancement was evaluated and compared under several conditions using an echoendoscope. Results: The mean maximum resistance force of the needle alone was higher for the FNB needles than for the FNA needles. The mean maximum resistance force of the needle in the echoendoscope with free angle demonstrated that the resistance forces were between 2.10 and 2.34 Newton (N). The mean maximum resistance force increased upon increases in angle of the tip of echoendoscope, particularly in the FNA needles. Among the FNB needles, SharkCore™ had the lowest resistance force (2.23 N). The mean maximum resistance force of the needle alone, the needle in the echoendoscope with free angle, and the needle in the echoendoscope with full-up angle for SonoTip® TopGain were all similar to that of Acquire™. Conclusion: SonoTip® TopGain had similar puncturability to Acquire™ in all tested situations. Regarding the puncturability, SharkCore™ is most suitable for insertion into target lesions, when tight echoendoscope tip angle is necessary.

Comparison of endoscopic ultrasound-guided fine needle aspiration cytology versus endoscopic biopsy for the diagnosis of subepithelial lesions of the upper and lower gastrointestinal tract: A 10-year retrospective single institution analysis.

BACKGROUND: The aim of this study is to compare the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) versus endoscopic biopsy for the diagnosis of gastrointestinal (GI) subepithelial lesions (SELs) using surgical resection as the gold standard. METHODS: All patients who underwent EUS-FNA of upper and lower GI SELs over a 10-year period (2010 through 2019) were retrospectively reviewed. The medical records of all patients were reviewed and data extracted from the endoscopy, pathology, and surgical reports were analyzed. RESULTS: In total, 283 patients with ages ranging from 21 to 92 years underwent EUS-FNA for evaluation of GI SELs, 117 (41%) patients underwent endoscopic biopsy and 82 (29%) patients had concurrent surgical resection specimen. EUS-FNA was obtained from the stomach in 167 (59%) patients, duodenum in 51 (18%) patients, esophagus in 38 (13%) patients, and colorectum in 27 (10%) patients. It was found that the largest percentage of lesions originated in the muscularis propria (36%), followed by the submucosa (26%), deep mucosa (13%), and not specified in 21%. The concordance between EUS-FNA and endoscopic biopsy was good (correlation coefficient of 0.631, p < .001). EUS-FNA versus endoscopic biopsy in resected cases showed sensitivity and specificity of 78% versus 68% and 84% versus 100%, respectively. The EUS-FNA has an accuracy of 80% compared to 74% in biopsy. The diagnostic yield of EUS-FNA and endoscopic biopsy was 64% versus 55%. CONCLUSION: EUS-FNA is more sensitive and more accurate than endoscopic biopsy for diagnosing GI SELs with a good concordance between the two techniques.

The Utility of Endoscopic-Ultrasonography-Guided Tissue Acquisition for Solid Pancreatic Lesions.

Endoscopic-ultrasonography-guided tissue acquisition (EUS-TA) has been widely performed for the definitive diagnosis of solid pancreatic lesions (SPLs). As the puncture needles, puncture techniques, and sample processing methods have improved, EUS-TA has shown higher diagnostic yields and safety. Recently, several therapeutic target genomic biomarkers have been clarified in pancreatic ductal carcinoma (PDAC). Although only a small proportion of patients with PDAC can benefit from precision medicine based on gene mutations at present, precision medicine will also be further developed for SPLs as more therapeutic target genomic biomarkers are identified. Advances in next-generation sequencing (NGS) techniques enable the examination of multiple genetic mutations in limited tissue samples. EUS-TA is also useful for NGS and will play a more important role in determining treatment strategies. In this review, we describe the utility of EUS-TA for SPLs.

EUS-Guided Biopsy with a Novel Puncture Biopsy Forceps Needle-Feasibility Study.

Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) or biopsy (FNB) to diagnose lesions in the gastrointestinal tract is common. Demand for histology sampling to identify treatment-specific targets is increasing. Various core biopsy FNB needles to obtain tissue for histology are currently available, however, with variable (37-97%) histology yields. In this multicenter study, we evaluated performance, safety, and user experience of a novel device (the puncture biopsy forceps (PBF) needle). Twenty-four procedures with the PBF needle were performed in 24 patients with a suspected pancreatic lesion (n = 10), subepithelial lesion (n = 10), lymph node (n = 3), or pararectal mass (n = 1). In 20/24 (83%) procedures, the PBF needle yielded sufficient material for interpretation (sample adequacy). In 17/24 (71%), a correct diagnosis was made with the material from the PBF needle (diagnostic accuracy). All participating endoscopists experienced a learning curve. (Per)procedural technical issues occurred in four cases (17%), but there were no adverse events. The PBF needle is a safe and potentially useful device to obtain an EUS-guided biopsy specimen. As the design of the PBF needle is different to core biopsy FNB needles, specific training will likely further improve the performance of the PBF needle. Furthermore, the design of the needle needs further improvement to make it more robust in clinical practice.

Resectable pancreatic solid lesions: Time to move from surgical diagnosis?

Benign or malignant conditions can present as pancreatic solid lesions (PSLs), and a thorough diagnostic workup is necessary to differentiate them. The need to acquire a tissue sample to reach a definitive diagnosis should be stratified by the findings at multidetector computed tomography (MDCT) with a pancreatic protocol. Tissue biopsy is currently indicated in patients fit for chemotherapy in whom a metastatic tumor or a locally advanced unresectable lesion are discovered. For these patients, EUS-guided tissue acquisition, with fine-needle aspiration (FNA) or biopsy represents the gold standard to provide a definitive cyto- and/or histopathologic diagnosis, with a high rate of accuracy. For resectable PSLs with a nonhypoenhancing MDCT pattern, which is not disease specific, a tissue diagnosis to distinguish benign from malignant etiologies appears mandatory. On the other hand, for hypo-enhancing PSLs, the debate of whether to obtain a preoperative definitive diagnosis still favors direct surgery. However, availability of novel EUS-guided fine-needle biopsy needles, which can ameliorate the negative predictive value of EUS-FNA and allow performance of DNA and RNA whole-genome extraction and RNA sequencing, coupled with the increasing evidence that preoperative neoadjuvant chemotherapy can be of value for these patients may change completely the diagnostic and therapeutic approach to resectable PSLs. These recent breakthroughs suggest the need for a new multidisciplinary consensus meeting to integrate them into the decision-making process assessing the need for preoperative tissue diagnosis in resectable PSLs.

In memoriam: Fine-needle aspiration, birth: Fine-needle biopsy: The changing trend in endoscopic ultrasound-guided tissue acquisition.

BACKGROUND AND AIM: Fine-needle aspiration (FNA) cytology has been the preferred technique for procuring tissue at endoscopic ultrasound (EUS) procedures for the past 25 years. To overcome some of the limitations of FNA cytology, fine-needle biopsy (FNB) has been recently developed to yield histological tissue. Main objective was to compare the diagnostic yield of FNB compared to FNA for both onsite and offsite specimen assessment. METHODS: A retrospective study was conducted at a single tertiary referral center to evaluate the outcomes of FNA and FNB over a 4-year period. EUS-guided tissue sampling was carried out using 22- or 25-G FNA needles from 2014 to 2015, and 22-G FNB needle was used from 2016 to 2017. RESULTS: Of 3020 patients undergoing EUS-guided sampling of solid mass lesions (pancreatic masses 71.3%, other lesions 28.7%), FNA was carried out in 68.9% and FNB in 31.1%. Median number of passes required for diagnostic adequacy on rapid onsite evaluation was significantly lower for FNB compared to FNA (1 [IQR: 1-2] vs 2 [IQR 1-3], P < 0.001). Diagnostic yield on cell block was also significantly superior with FNB compared to FNA (92.3 vs 71.1%, P < 0.001). The superior performance of FNB over FNA was observed for both pancreatic (P < 0.001) and non-pancreatic lesions (P < 0.001). CONCLUSION: Given these promising findings, in the future, EUS-guided FNB will likely be the preferred technique for sampling of solid mass lesions.

Endoscopic ultrasound-guided tissue acquisition.

Endoscopic ultrasound (EUS) is an indispensable tool for tissue acquisition in patients with gastrointestinal tumors. While fine-needle aspiration (FNA) has been routinely carried out for establishing tissue diagnosis, the emerging concept of tailoring chemotherapeutic agents based on molecular markers has increased the demand for core tissue procurement by means of EUS-guided fine-needle biopsy (EUS-FNB). In addition, FNB may offset the limitations of FNA wherein the diagnostic sensitivity is incumbent on the availability of an onsite cytopathologist. Given the increasing number of procedures being done, developing a unit-specific algorithmic approach for needle selection is important to improve the procedural efficiency and utilization of resources. Finally, the best outcomes can be attained only by practicing evidence-based techniques, procuring adequate quantity of sample for ancillary studies and processing the specimens appropriately.