Evaluation of Fine Needle Biopsy (FNB) for Endoscopic Ultrasound (EUS)-guided tissue acquisition of pancreatic masses to negate the need for rapid on-site evaluation: A randomized control trial

Background and Objectives@#The benefits of rapid on-site evaluation (ROSE) of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid masses have not been convincingly shown in large, randomized trials. New equipment using EUS-guided fine needle biopsy (FNB) allows for more material to be acquired that may obviate the need for ROSE. This study aimed to evaluate if EUS-FNB without ROSE was non-inferior to EUS-FNA with ROSE in solid pancreatic masses (SPMs). @*Methods@#Patients with SPMs requiring tissue sampling were randomly assigned to undergo either EUS-FNA with ROSE or EUS-FNB without ROSE. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy and secondary endpoints were specimen quality, complication rates, and procedure time. @*Results@#Seventy-eight patients were randomized and analyzed (39 EUS-FNA with ROSE and 39 EUS-FNB without ROSE). Non-significantly different diagnostic accuracies were noted in both groups (97% with ROSE and 100% without ROSE, P < 0.371). The bloodiness of histologic samples and complication rates were not significantly different between groups. A significantly shorter mean sampling procedural time was noted for EUS-FNB over EUS-FNA with ROSE (30.4 ± 10.4 vs 35.8 ± 9.8 minutes, P < .02). @*Conclusions@#EUS-FNB demonstrated equal diagnostic accuracy with shorter procedure times in evaluating SPMs compared to EUS-FNA with ROSE. These new-generation FNB needles may obviate the need for ROSE.

Impacto da pandemia de COVID-19 nos procedimentos de ultrassonografia endoscópica em uma unidade de endoscopia de alto volume no Brasil / The impact of the covid-19 pandemic on endoscopic ultrasound procedures in a high-volume endoscopy unit in brazil

ABSTRACT Background: Reports of the impact of the 2020 COVID-19 pandemic period/2020 on endoscopic ultrasound (EUS) are scarce. Objective: We analyzed the impact of the pandemic period/2020 on the demographics, indications, and number of diagnostic EUS (D-EUS) and interventional EUS (I-EUS) procedures performed in a high-volume endoscopy unit compared with the previous non-pandemic period/2019. Methods: We retrospectively reviewed the medical records of all patients undergoing D-EUS or I-EUS from March 1, 2019, to February 29, 2020 (non-pandemic period/2019) and from March 1, 2020, to February 28, 2021 (pandemic period/2020). Data compared between the study periods included sex, age, comorbidities, EUS findings and diagnosis, need for interventional procedures during EUS, and adverse events (AEs). Results were significant at P<0.05. Results: EUS procedures decreased from 475 in the non-pandemic period/2019 to 289 in the pandemic period/2020, accounting for a 39% reduction. In non-pandemic period/2019, 388 (81.7%) D-EUS and 88 (18.5%) I-EUS were performed, against 206 (71.3%) D-EUS and 83 (28.7%) I-EUS in pandemic period/2020 (P=0.001). Only 5/289 (1.7%) patients had COVID-19. Fewer patients with comorbidities underwent EUS during pandemic period/2020 due to lockdown measures (P<0.001). D-EUS decreased, whereas I-EUS increased (P<0.001). EUS-guided tissue acquisition (EUS-TA) was the most common I-EUS, performed in 83/289 (28.7%) patients in pandemic period/2020, against 88/475 (18.5%) in non-pandemic period/2019 (P=0.001). AEs did not differ significantly between the study periods. Conclusion: Pandemic Period/2020 had a moderate impact on reducing EUS procedures due to the risks involved. Although I-EUS increased, EUS-related AEs did not. Solid and cystic pancreatic tumors remained a major indication for EUS-TA even during the pandemic period/2020.

RESUMO Contexto: Os dados sobre o impacto da pandemia de COVID-19 2020 na ultrassonografia endoscópica (EUS) são escassos. Objetivo: Analisamos o impacto do período pandêmico/2020 na demografia, indicações e número das EUS diagnósticas (D-EUS) e intervencionistas EUS (I-EUS) realizados em uma unidade de endoscopia de alto volume e os comparamos com o período imediatamente anterior não-pandêmico/2019. Métodos: Revisamos retrospectivamente os prontuários de todos os pacientes submetidos a D-EUS ou I-EUS de 1 de março de 2019 a 29 de fevereiro de 2020 (período não-pandêmico/2019) e de 1º de março de 2020 a 28 de fevereiro de 2021 (período da pandemia/2020). Comparamos os dados entre os períodos do estudo incluímos o sexo, idade, comorbidades, achados e diagnóstico da EUS, necessidade de procedimentos intervencionistas durante a EUS e a ocorrência de eventos adversos (EAs). Os resultados foram significativos com P<0,05. Resultados: O número de ecoendoscopias diminuíram de 475 no período não-pandêmico/2019 para 289 no período pandêmico/2020, representando uma redução de 39%. No período não-pandêmico/2019 e pandêmico/2020 foram realizados 388 (81,7%) D-EUS e 88 (18,5%) I-EUS, contra 206 (71,3%) D-EUS e 83 (28,7%) I-EUS, respectivamente (P=0,001). Apenas 5/289 (1,7%) pacientes tinham COVID-19. Menos pacientes com comorbidades realizaram EUS durante o período pandêmico/2020 devido as medidas de bloqueio (P<0,001). D-EUS diminuiu, enquanto I-EUS aumentou (P<0,001). A EUS associada a aquisição tecidual (EUS-AT) foi a I-EUS mais comum, realizada em 83/289 (28,7%) pacientes no período pandêmico/2020, versus 88/475 (18,5%) no período não-pandêmico/2019 (P=0,001). Os EAs não diferiram significativamente entre os períodos do estudo. Conclusão: O período da pandemia/2020 teve impacto moderado na redução da EUS devido aos riscos envolvidos. Embora o I-EUS tenha aumentado, os EAs relacionados ao EUS não aumentaram. Os tumores pancreáticos sólidos e císticos permaneceram como uma das principais indicações para EUS-AT mesmo durante o período pandêmico/2020.

Prospective Assessment of the Performance of a New Fine Needle Biopsy Device for EUS-Guided Sampling of Solid Lesions

BACKGROUND/AIMS: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) remains the most common EUS-guided tissue acquisition technique. This study aimed to evaluate the performance of a new Franseen tip fine needle biopsy (FNB) device for EUSguided sampling of solid lesions and compare it with the historical FNA technique. METHODS: Acquire® 22 G FNB needle (Boston Scientific Co., Natick, MA, USA) was used for solid tumor sampling (Study group). Tissue was collected for rapid on-site evaluation, and touch and crush preparations were made. Historical EUS-FNA samples obtained using Expect® 22 G FNA needle (Boston Scientific Co.) were used as controls (Control group). All specimens were independently evaluated by two cytopathologists blinded to the formal cytopathological diagnosis. RESULTS: Mean cell block histology scores were significantly higher (p=0.046) in the FNB group (51 samples) despite a significantly lower (p < 0.001) mean number of passes compared to the FNA group (50 specimens). The overall diagnostic yields for the FNB vs. FNA groups were 96% vs. 88%. The degree of tumor differentiation was adequately assessed in all cell block qualifying lesions in the FNB group. Two patients developed post-FNB abdominal pain. CONCLUSIONS: The new Franseen tip FNB device provides histologically superior and cytologically comparable specimens to those obtained by FNA, but with fewer passes.

Fine-Needle Biopsy: Should This Be the First Choice in Endoscopic Ultrasound-Guided Tissue Acquisition?

Endoscopic ultrasound (EUS)-guided tissue acquisition is an indispensable technique for the diagnosis of many diseases of the gastrointestinal tract and adjacent structures. EUS-guided fine-needle aspiration (EUS-FNA) is known for its high accuracy and low complication rate. However, the outcome of EUS-FNA highly depends on several factors such as the location and characteristics of the lesion, endosonographer's experience, technique of sampling and sample preparation, type and size of the needle used, and presence of a cytopathologist for rapid on-site examination. EUS-guided fine-needle biopsy is useful to obtain core tissue samples with relatively fewer passes. Aspiration of core tissue with preserved architecture is beneficial for the diagnosis of certain diseases and the performance of ancillary testing such as tumor molecular profiling. Issues related to needle size, type, and their acquired samples for cytologic and histologic evaluation are discussed here.