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Objectives: This study aimed to compare the diagnostic yield of mucosal incision-assisted biopsy (MIAB) and endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) with a rapid on-site evaluation (ROSE) for gastric subepithelial lesions (SEL) suspected of being gastrointestinal stromal tumors (GIST) with an intraluminal growth pattern., Methods: This was a prospective randomized, cross-over multicenter study. The primary outcome was the diagnostic yield of EUS-FNA and MIAB. The secondary outcomes were the technical success rate, complication rate, procedure time and biopsy frequency., Results: A total of 47 patients were randomized to the MIAB group (n = 23) and EUS-FNA group (n = 24). There was no significant difference in the diagnostic yield of MIAB and EUS-FNA (91.3% vs 70.8%, P = 0.0746). The complication rates of MIAB and EUS-FNA did not differ to a statistically significant extent. The mean procedure time in the MIAB group was significantly longer than that in the EUS-FNA group (34 vs 26 min, P = 0.0011)., Conclusions: The diagnostic yield of MIAB was satisfactorily as high as EUS-FNA with ROSE for gastric SEL with an intraluminal growth pattern., (© 2019 Japan Gastroenterological Endoscopy Society.)

Background and Aim: Tissue acquisition in pancreatic cystic lesions (PCL) is the ideal method for diagnosis and risk stratification for malignancy of these lesions. Direct sampling from the walls of PCL with different devices has shown better results than cytology from cystic fluid. We carried out a retrospective, multicenter study to evaluate the feasibility, safety, and diagnostic yield of a micro-forceps, specifically designed to be used through a 19-gauge needle after endoscopic ultrasonography (EUS)-guided puncture of PCL., Methods: We retrospectively collected data from patients who underwent EUS-through-the-needle biopsy (EUS-TTNB) in PCL at six referral centers., Results: The sampling procedure was carried out in 56 patients (mean age 57.5 ± 13.1 years, M:F 17:39), and was technically successful in all of them (100%; 95% confidence interval [CI], 94-100%). Adverse events occurred in 9/56 (16.1%; 95% CI, 8-28%) patients, with self-limited intracystic hemorrhage the most common (7/56, 12.5%; 95% CI, 5-24%). All adverse events were mild, and resolved without any specific intervention. Specimens were considered adequate for histological diagnosis in 47/56 (83.9%; 95% CI, 72-92%). In two of these patients, despite the histological adequacy, a diagnosis could not be reached. In two other cases, a specimen sufficient for a cytological diagnosis was obtained. Overall diagnostic yield by combining cytological and histological samples was 47/56 (83.9%; 95% CI, 72-92%)., Conclusion: EUS-TTNB with micro-forceps in PCL is feasible, safe, and has a high diagnostic yield. Future prospective studies are needed to better assess the clinical impact of EUS-TTNB on the management of PCL., (© 2018 Japan Gastroenterological Endoscopy Society.)

Background and Aim: Recently, a 22-gauge (G) needle with a Franseen tip design was developed for endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB). The present study evaluated the performance of the Franseen biopsy needle in EUS-guided tissue acquisition., Methods: This is a retrospective study of patients who underwent EUS-FNB using the Franseen needle. Lesions were sampled using either the Franseen needle only or after failed diagnostic fine-needle aspiration (FNA). After rapid onsite evaluation (ROSE), two dedicated passes were carried out for histological assessment using the cell block technique. Main outcomes were: (i) rates of diagnostic adequacy for ROSE and histological diagnosis; and (ii) quality of histology as determined by total tissue area and tumor percentage in tissue., Results: Thirty patients underwent EUS-FNB of pancreatic or other masses over a 3-month period. Twenty-four lesions were sampled using the Franseen needle only and six after failed diagnostic FNA. Final diagnosis was pancreatic cancer in 12, gastrointestinal stromal cell tumor in five, other tumors in four and benign disease in nine. Diagnostic adequacy for ROSE was 96.6% and histological diagnosis was established in 96.7% of patients. Median tissue area was 2.9 mm 2 (IQR = 0.68-8.71 mm 2 ) and median tumor percentage in tissue was 73.9% (IQR = 44-97.6). Rates of technical success and adverse events were 96.7 and 3.3%, respectively., Conclusion: Preliminary data suggest that the Franseen needle yields diagnostic material for ROSE and histology in >95% of patients., (© 2016 Japan Gastroenterological Endoscopy Society.)

Background and Aim: Endoscopic ultrasound (EUS) aspiration needles are single-use devices. However, in many centers, because of cost-constraints, these devices are reused multiple times. We studied microbiological contamination and bioburden on reprocessed needles to evaluate whether these devices can be successfully sterilized., Methods: We studied 10 EUS needles each of 19 G, 22 G, and 25 G in size, and five 22-G ProCore needles. After initial use, each needle was reprocessed by a standardized protocol. We used standard microbiological cultures, as well as ATP bioluminescence technique to quantify bioburden as relative light units (RLU). We defined significant soil contamination by RLU values >200. We also used extractant fluid to disrupt cell membranes in an attempt to enhance ATP detection., Results: We found culture positivity in 3/34 (8.8%), and detectable bioburden on the exposed surface of 33/35 (94.3%), and inside lumen of 29 (82.9%) reprocessed FNA needles. Significant bioburden was found in three (8.6%) and two (5.7%) needles on the surface and lumen, respectively. We found that use of extractant fluid enhanced detection of bioburden. Larger (19 G) needles had higher surface contamination (P = 0.016), but there was no relation of luminal contamination with needle diameter (P = 0.138). Sheath design and presence of side bevel did not influence extent of contamination. There was significant correlation between the surface and intraluminal bioburden (P < 0.001)., Conclusions: There is significant bioburden in reprocessed EUS needles; standard microbiological cultures have low sensitivity for detection of needle contamination. We have provided objective evidence for the futility of reprocessing attempts, and practice of EUS needle reuse should be discontinued., (© 2016 Japan Gastroenterological Endoscopy Society.)

Background and Aim: Previous studies comparing endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) results with different gauge needles have all been carried out with the stylet in place and show no clear advantage to the larger 22-G needle. Similar data for stylet-free EUS-FNA (SF-EUS-FNA) are unavailable. The aim of the present study was to determine whether diagnostic yield and specimen adequacy is superior with the 22-G needle as compared to the 25-G needle., Methods: All patients ≥ 18 years referred for solid-lesion EUS-FNA were eligible. Patients with suspected diagnosis of lymphoma, gastrointestinal stromal tumor, sarcoidosis, significant coagulopathy (international normalized ratio > 1.5 or platelets < 50000/mm(3)), use of clopidogrel within 7 days of EUS, and pregnancy were excluded. The two needles were compared regarding diagnostic yield, sample adequacy, bloodiness, ease of puncture, visibility, number of passes, failures, and complications., Results: One hundred and twenty consecutive patients were included and 126 lesions were sampled. Sensitivity, specificity, positive predictive value and negative predictive value for the 22-G SF-EUS-FNA were 83%, 100%, 100% and 56%, respectively, and for the 25-G SF-EUS-FNA were 88.8%, 100%, 100% and 76.5%, respectively (P=NS). There were no significant differences between the 22-G and the 25-G FNA needles in sample adequacy, bloodiness, ease of puncture, FNA failure, visibility, number of passes and complications; and no significant differences between either needle were found in relation to lesion site., Conclusion: For SF-EUS-FNA, the larger 22-G needle offers no advantage over the smaller 25-G needle.

Background and Aim: Endoscopic ultrasound-guided fine-needle aspiration cytology (EUS-FNA) is traditionally carried out with the stylet, as it is believed to prevent blockage or contamination of the needle by tissue coming from the gastrointestinal wall. However, this recommendation has not been demonstrated on an empirical basis. The aim of the present study was to compare the yield of EUS-FNA in a very large series of patients with (S+) and without (S-) the stylet., Methods: Until 2004, the stylet was used for EUS-FNA in our center. After that, the stylet was never used. The results of all EUS-FNA in solid lesions carried out by one endosonographer with the same needle type were compared before and after stylet use was stopped., Results: 3364 EUS-FNA procedures (in 3078 patients) in solid lesions were included (1483 S+ and 1881 S-). There was no significant difference between the S+ and S- results for any variable other than the number of passes required. The number of passes was significantly lower in the S- group when sampling lymph nodes, wall lesions and when carrying out biopsies through the gastric or rectal wall. However the statistical differences disappeared after controlling for malignancy, location and lesion size., Conclusion: This very large comparative study showed no benefit in diagnostic yield when using the stylet for EUS-FNA., (© 2012 The Authors. Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society.)

Background and Study Aims: Diagnostic yield of endoscopic ultrasound (EUS)-fine-needle aspiration (FNA) varies depending on the equipment used and the site targeted. Multiple needle passes are usually required to obtain a diagnosis. A new needle incorporating a side-port carries a theoretical advantage regarding acquisition of cytological material. The aim of the study was to demonstrate the safety and efficacy of the Olympus side-port needle in solid upper gastrointestinal indications., Patients and Methods: A prospective multicenter evaluation of patients referred for EUS-FNA for solid lesions was performed across six tertiary gastroenterology referral centers in four capital cities in Australia. The main outcome measures include cytological diagnosis, number of needle passes required for diagnosis and complication rates., Results: Thirty patients (17 men; 13 women) with a mean age of 67.5 years were studied. Indications included pancreatic or biliary mass in 24 patients, retroperitoneal or periduodenal mass in 2, enlarged lymph node in 2, a gastric submucosal tumor in 1 and a subcarinal mass in 1. The mean size of the lesions was 3.47 cm (range, 0.5-8 cm). All but one case had a diagnosis made (96.7%). The mean number of passes required to reach a diagnosis was 1.7. In neoplastic lesions the diagnosis was made with a mean of 1.6 passes. No complications were encountered., Conclusions: The new EUS-FNA needle with side port appears effective and safe in solid upper gastrointestinal EUS-FNA indications., (© 2012 The Authors. Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society.)

Introduction: A prior study with 22-gauge needles recommended more than seven needle passes for endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) of solid pancreatic lesions (SPL) without onsite cytopathology for optimal acquisition of cytopathological diagnosis. The feasibility of this recommendation should be re-evaluated considering the later development and popularity of 25-gauge EUS-FNA needles. We aimed to determine the optimal number of needle passes for cytopathological specimen acquisition with 25-gauge needles for EUS-FNA of SPL., Methods: A preliminary prospective study of 22 patients with an onsite cytopathology technician showed a sensitivity of 93.3% and a specificity of 100% with four needle passes that was not statistically different from five needle passes. Based on our preliminary study, we fixed the number of needle passes to four (Group A). As a control group, we carried out sampling in consecutive patients using 25-gauge needles with an onsite cytopathologist (Group B). Sampling rate, diagnostic value and complications were evaluated., Results: We enrolled 20 patients in each group. Sampling rate was higher in Group B (20/20, 100%) than in Group A (19/20, 95%), but there was no statistical difference between them (P-value = 0.31). In Group A, sensitivity, specificity and accuracy were 100% among 19. In Group B, sensitivity was 94.1%, specificity 100%, accuracy 95%. There were also no statistical differences between the groups. No complications were seen., Conclusion: Our study suggests that four needle passes using a 25-gauge needle may be sufficient for EUS-FNA of SPL where onsite cytology is not available., (© 2012 The Authors. Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society.)

Aim: A number of potential variables are associated with the diagnostic accuracy of endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA). The aim of this study was to evaluate factors affecting the diagnostic accuracy of EUS-FNA for upper gastrointestinal submucosal or extraluminal solid lesions., Methods: Patients with such lesions who underwent EUS-FNA between January 2009 and December 2010 were studied retrospectively. Needles of 22, 25 and 19 gauge were used. The associations between the EUS-FNA results and factors such as mass location, mass size, needle size, number of needle passes, combined histologic-cytologic analysis and final diagnosis were analyzed., Results: A total of 170 EUS-FNA procedures were performed in 158 patients with upper gastrointestinal submucosal or extraluminal solid lesions. The overall accuracy of EUS-FNA was 86.5% (147/170). The diagnostic accuracy with three or more needle passes was higher than with less than 3.0 needle passes (90.0%, 108/120 vs 78.0%, 39/50; P < 0.05). Mass location, mass size, and final diagnosis were not associated with EUS-FNA accuracy. Combined cytologic-histologic analysis had significantly higher diagnostic accuracy than either cytologic or histologic analysis alone (P < 0.001). In a subgroup of 90 patients, both 22 and 25 gauge needles were used for EUS-FNA. The overall diagnostic accuracy was similar for 25 gauge needles and 22 gauge needles (80.0% vs 78.9% P = 1.000) in this subgroup., Conclusion: Overall, 25 and 22 gauge needles have a similar diagnostic accuracy. Our results suggest that 3.0 or more needle passes and combined cytologic-histologic analysis enhance the diagnostic accuracy of EUS-FNA., (© 2012 The Authors. Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society.)