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Background: The cutoff value for stereomicroscopic on-site evaluation (SOSE) in endoscopic ultrasound-guided tissue acquisition (EUS-TA) has high diagnostic sensitivity when a Franseen needle is employed for upper gastrointestinal subepithelial lesions (SELs) (stereomicroscopically visible white core [SVWC] ≥ 4 mm)., Aim: We aimed to determine whether high diagnostic sensitivity could be obtained when EUS-TA was performed using a Fork-tip needle., Methods: Twenty-one patients were prospectively registered. Patients underwent EUS-TA using a Fork-tip needle for upper gastrointestinal SELs at Kitasato University Hospital between January and November 2022. Punctures were made twice using the needle, and SOSE was conducted for each specimen. Blood and physical examination were performed to assess adverse events. Pathological diagnosis was made using hematoxylin and eosin-stained sections and immunohistochemical staining. Statistical comparisons were completed using Fisher's exact tests., Results: The diagnostic rate of EUS-TA was 100% (21/21 cases). The final diagnosis was gastrointestinal stromal tumor in 17 (81.0%) and leiomyoma in 4 (19.0%) patients. SOSE was conducted on all 42 punctures, and the tissue sampling rate was 100% (42/42 punctures). Specimens with SVWC ≥ 4 mm were collected in 97.6% punctures (41/42 punctures) and the diagnostic sensitivity for these specimens was 100% (41/41 punctures), which is significantly higher (p < 0.0238) compared to the absence of cutoff value (diagnostic sensitivity of 0%). No EUS-TA-related adverse events occurred., Conclusions: EUS-TA combined with SOSE for upper gastrointestinal SEL using a fork-tip needle had a high diagnostic rate, and the cutoff value of SVWC ≥ 4 mm had high diagnostic sensitivity., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Cutting needles are thought to be effective as biopsy needles. A few types of cutting needles are available for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), and the Menghini-type needle is an end-type cutting needle., Aims: A prospective randomized controlled trial was conducted to compare the results of EUS-FNA using a Menghini-type needle (needle M) versus a conventional needle (needle S)., Methods: The main eligibility criteria were as follows: patients with a pancreatic mass referred for EUS-FNA, ≥ 20 years old, and a performance status < 4. The primary outcome was the sample quality. The secondary outcomes were factors associated with the sample quality, diagnostic accuracy, and adverse events., Results: A total of 97 patients were enrolled in this study. The sample quality for total puncture with needle M (92.8%) was significantly higher than that with needle S (81.4%) (p = 0.0305). The tumor size (p = 0.033) and type of needle (p = 0.031) were significant factors associated with adequate tissue collection in univariate and multivariate analyses (odds ratio [OR] 2.71; 95% confidence interval [CI] 1.12-6.54; p = 0.027 for tumor size, and OR 2.93; 95% CI 1.23-8.21; p = 0.0153 for type of needle). The diagnostic accuracy of each needle was 88.7% (86/97) with needle M and 73.2% (71/97) with needle S. Adverse events occurred in 2 of the 97 patients (0.02%)., Conclusion: A Menghini-type needle was able to obtain core tissue for histology more effectively than a conventional aspiration needle., Trial Registration Numbers: UMIN registration number of 000020668., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)

Background: EUS-guided liver biopsy (EUS-LB) has been shown to be a safe and effective alternative to percutaneous liver biopsy. The optimal needle device and technique for EUS-LB is still evolving. The aim of this study was to compare the efficacy of two second-generation 19G fine-needle biopsy (FNB) (Franseen- and Fork-tip) devices for EUS-LB., Methods: This is a repeated-measure crossover study with a prospectively maintained cohort of patients. We performed EUS-LB with a one-pass and single-actuation method using two 19G FNB needles in 22 consecutive patients between 10/2018 and 9/2019. Patients were randomized to left vs right liver lobes to be biopsied as well as the needle sequence. The specimens obtained were evaluated for adequacy for histologic diagnosis. The primary outcome was number of complete portal tracts (CPTs), post-fix aggregate, and longest specimen length. Secondary outcomes were prefix aggregate specimen length and the specimen adequacy judged by two expert pathologists., Results: A total of 44 liver biopsies were performed in 22 patients. The CPTs were higher in the Franseen-tip needle group compared to the Fork-tip needle group (14.4 vs 9.5, p = 0.043). Post-fix aggregate specimen length (44.9 mm vs 34.6 mm, p = 0.097), the post-fix longest specimen length (19.9 mm vs 13.7 mm, p = 0.175), and prefix aggregate specimen length (51.7 mm vs 45 mm, p = 0.265) were not significantly different. Both needles showed similarly high histologic adequacy (100% vs 95.5%, p = 0.312). Interestingly, the right of the liver showed higher yield of CPTs with both needles (Franseen, 16.2 vs. 12.8, p = 0.003, the Fork-tip, 12.8 vs. 7.0, p < 0.0001)., Conclusion: EUS-guided liver biopsy using the 19G Franseen-tip needle may provide more CPTs than 19G Fork-tip needle on a single-pass, single-actuation comparison.

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).

Background: Although endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has been widely used for the diagnosis of pancreatic tumors, the ability to obtain adequate pancreatic tumor tissue needs to be improved., Aims: This study was performed to compare a newly designed 21-gauge needle (EUS Sonopsy CY; Hakko Medical, Nagano, Japan) and a standard 22-gauge needle for tissue sampling of solid pancreatic masses., Methods: Consecutive patients with solid pancreatic masses who underwent EUS-FNA with either the EUS Sonopsy CY or the 22-gauge needle from June 2014 to December 2016 were enrolled. The primary outcome was comparison of the diagnostic yield of the FNA samples. The secondary outcomes were comparison of technical success, diagnostic ability for malignancy, and complications., Results: A total of 93 patients (40.9% female; mean age, 70.1 years) underwent EUS-FNA with the EUS Sonopsy CY (n = 47) or the standard 22-gauge needle (n = 46). The technical success rate was 100% in both groups, and the overall diagnostic accuracy for malignancy was similar between the groups (100% in the EUS Sonopsy CY group vs. 95.7% in the 22-gauge needle group, P = 0.242). Nevertheless, the EUS Sonopsy CY resulted in significantly higher scores for cellularity (P = 0.006) and lower scores for blood contamination (P < 0.001). The procedure-related complication rate was comparable between the groups (P = 0.148)., Conclusions: The EUS Sonopsy CY provided higher-quality specimens for histological evaluation in terms of both sample cellularity and blood contamination for the diagnosis of solid pancreatic masses., Trial Registration: The study was registered in a clinical trial registry, No. UMIN000032598.

Background: The necessity of histological analysis is increasing. A 19-gauge histology needle (PC19) in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has recently been developed and has shown high yields of tissue acquisition and histological diagnosis., Aims: To compare the histological diagnostic yield in single-pass EUS-FNA for solid lesions using PC19 and a standard 19-gauge needle (EC19)., Patients and Methods: Consecutive patients with solid lesions were enrolled and underwent one pass with each of PC19 and EC19 for EUS-FNA with the randomized order of the needles. The primary endpoint was the histological diagnostic accuracy. The secondary endpoints were the feasibility, yield of histological core, cytological and overall diagnostic accuracies, and adverse events. Subgroup analysis was performed for the optimal situation with PC19., Results: Of the 115 patients, 110 underwent EUS-FNA and five were excluded. EUS-FNA was performed from the esophagus in four, stomach in 80, or duodenum in 26. The final diagnosis was malignancy in 100 and benign in 10. The feasibility was 98.2 and 97.3% with PC19 and EC19, respectively (p = 1.00). The rate of presence of a histological core and the histological, cytological, and overall diagnostic accuracies for PC19 versus EC19 were 84.6 versus 80.9% (p = 0.593), 83.6 versus 73.6% (p = 0.099), 63.6 versus 56.4% (p = 0.335), and 90.0 versus 79.1% (p = 0.039), respectively. PC19 was favored in the trans-esophageal/gastric approaches to obtain a histological diagnosis (p = 0.013). Adverse events were observed in four patients., Conclusion: Single-pass EUS-FNA with PC19 was feasible and showed significantly higher overall diagnostic accuracy and an increased tendency towards histological diagnostic accuracy, especially with trans-esophageal/gastric FNA.

Background: Theoretically, use of the stylet during endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) will prevent the tip of the needle from being blocked and the sample from being contaminated, improving the quality and diagnostic yield of specimens., Aim: This meta-analysis aimed to evaluate any benefit from the use of a stylet during EUS-FNA., Methods: MEDLINE, EMBASE, WEB of SCIENCE, and the Cochrane Central Register of Controlled Trials were searched for articles published through October 2015. A fixed-effects model was used to calculate the pooled effects when there is no heterogeneity and a random-effects model was used in situations with significant heterogeneity., Results: Five prospective randomized controlled studies and two retrospective studies of a total of 5491 specimens (2504 specimens in the S+ group and 2987 specimens in the S- group) were included in this study. The pooled analysis demonstrated no significant differences in the adequate sample rate between the S+ group (2135/2504, 85.26 %) and S- group (2609/2987, 87.35 %) [odds ratio 0.94 (95 % confidence interval 0.79-1.11), p = 0.45]. Furthermore, the rate of cellularity > 50 %, the contamination rate, and the blood contamination rate were not significantly superior in the S+ group when compared with the S- group., Conclusions: Whether the use of a stylet improves the proportion of adequate specimens or quality of the specimen is questionable. Our results suggest that the use of a stylet dose not guarantee any advantage during EUS-guided tissue sampling.

Background: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic masses is an established procedure for obtaining a pathological specimen. However, application of suction during EUS-FNA is still controversial and the efficacy of the slow-pull technique was recently reported for new core biopsy needles., Aim: The purpose of this study was to compare the suction and slow-pull techniques using regular FNA needles., Methods: The diagnostic yield of the suction and slow-pull techniques was retrospectively studied for patients who underwent EUS-FNA for pancreatic solid lesions., Results: A total of 367 passes (181 by suction and 186 by the slow-pull technique) were performed during 97 EUS-FNA procedures for 93 patients with pancreatic solid lesions. The slow-pull technique resulted in lower scores for cellularity (≥2 for 37.5 % vs. 76.7 %) but scores for contamination with blood were lower (≥2 for 25.0 % vs. 66.7 %) and sensitivity of diagnosis of malignancy was higher (90.0 % vs. 67.9 %) when a 25-gauge FNA needle was used. There were no significant differences between the two techniques when a 22-gauge needle was used. In multivariate analysis of 82 cases with malignancy, the slow-pull technique (odds ratio (OR) 1.92, P = 0.028), tumor size ≥25 mm (OR 4.64, P < 0.001), and tumor location in the body or tail (OR 2.82, P < 0.001) were associated with greater sensitivity., Conclusion: The slow-pull technique was associated with less contamination with blood and can potentially increase the diagnostic yield compared with the suction technique in EUS-FNA of pancreatic solid masses, especially with a 25-gauge FNA needle.

Background: Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) is a safe and effective way to sample lesions in the gastrointestinal tract. Rapid on-site specimen evaluation (ROSE) improves the accuracy of EUS-FNA. While data suggests that EUS with fine-needle biopsy (EUS-FNB) is effective, it remains unclear if ROSE is predictive of a final diagnosis when obtaining core specimens., Aim: The aim of this study was to investigate the utility of ROSE in achieving a final diagnosis for EUS-FNB core specimens., Methods: We evaluated 60 consecutive patients referred for EUS guided sampling of lesions within or adjacent to the gastrointestinal tract. All patients underwent EUS-FNB to evaluate the additive value of ROSE to the diagnostic accuracy of specimens obtained using a core biopsy needle. EUS-FNA was also performed in a majority of cases., Results: EUS-FNB was feasible in all 60 cases; on-site specimen adequacy and final diagnostic accuracy was 58 % [95 % confidence intervals (CI) 45.1-71.2] and 83 % (95 % CI 71.9-91.5), respectively. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value of ROSE for core biopsies were 65, 100, 100, and 39 %, respectively. On-site adequacy and diagnostic accuracy for EUS-FNA was 38 % (95 % CI 22.2-53.5) and 63 % (95 % CI 50.1-75.8), respectively. There were no significant complications., Conclusions: EUS-FNB is safe, feasible, and effective. ROSE of the core biopsy provides excellent PPV; however, an inadequate ROSE appears to be of limited value. Further prospective studies are needed to assess the optimal handling and onsite processing of core specimens to determine whether ROSE is beneficial for EUS-FNB.

Background: Several recent studies have investigated the utility of 19-, 22-, and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic and peri-pancreatic tumors., Aim: The objective of this study was to summarize data from these studies and estimate the effect of needle size on reported outcomes such as accuracy, adequacy, and complications., Methods: Systematic review and meta-analysis comparing the effect of needle size (19, 22, and 25G) on diagnostic accuracy, adequacy, number of needle passes, and complications., Results: 25G appear to confer an advantage in adequacy rates relative to 22G needles (risk difference = 0.12 %, 95 % CI 0.01, 0.25). There was no significant difference in accuracy with an overall sensitivity and specificity for 22G being 0.78 (95 % CI 0.74-0.81) and 1.00 (95 % CI 0.98-1.00) and an overall sensitivity and specificity for 25G being 0.91 (95 % CI 0.87-0.94) and 1.00 (95 % CI 0.97-1.00). There was no difference in number of passes or complications between 25 and 22G. The limited data available regarding 19G needles do not show evidence of improved outcomes with these devices., Conclusions: In the evaluation of pancreatic and peri-pancreatic lesions by EUS-FNA, 25G needles may confer an advantage in adequacy relative to 22G needles but confer no advantages with respect to accuracy, number of passes, or complications.