UNASSIGNED: The superiority of EUS-guided fine-needle biopsy (EUS-FNB) over fine-needle aspiration (FNA) remains controversial. This study aimed to compare the efficacy of FNB and FNA in immunohistochemistry (IHC)-required lesions, including, type 1 autoimmune pancreatitis (AIP), neuroendocrine tumor (NET), mesenchymal tumor, and lymphoma.
UNASSIGNED: In this multicenter study, specimens from all eligible patients who underwent EUS-FNB/FNA with these specific lesions were prospectively evaluated. Demographics, adequacy of specimens for IHC, diagnostic accuracy, and integrity of tissue were analyzed. Subgroup analysis and multivariate logistic regression were also performed to control confounders.
UNASSIGNED: A total of 439 patients were included for analysis. Most lesion types were type 1 AIP (41.69%), followed by NET, mesenchymal tumor, and lymphoma. FNB yielded specimens with better adequacy for IHC (82.41% vs. 66.67%, P < 0.001) and higher diagnostic accuracy (74.37% vs. 55.42%, P < 0.001). The superiority of FNB over FNA in adequacy for IHC (odds ratio, 2.786 [1.515-5.291]) and diagnostic accuracy (odds ratio, 2.793 [1.645-4.808]) remained significant after control of confounders including needle size, lesion site, lesion size, and endoscopists. In subgroup analysis, FNB showed higher diagnostic accuracy in AIP and mesenchymal tumor, whereas no statistically significant difference was observed in NET and lymphoma.
UNASSIGNED: FNB was superior to FNA needles in obtaining tissues with better adequacy and integrity. These results suggest that FNB should be considered a first-line modality in the diagnosis of IHC-required lesions, especially AIP and mesenchymal tumor. However, a randomized controlled trial with larger sample size is needed to further confirm our findings.

BACKGROUND: The effects of the Franseen needle size in endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) of solid pancreatic masses remain unclear. This study aimed to compare 25G and 22G Franseen needles in terms of adequate tissue acquisition from solid pancreatic masses.
METHODS: In this single-center, crossover, randomized noninferiority trial, eligible patients underwent EUS-FNB with both 25G and 22G Franseen needles in a randomized order between November 2018 and August 2020. Tissue specimens from each pass were separately evaluated based on the cellularity scoring system. The primary outcome was the proportion of acquired specimens allowing adequate histological assessment (cellularity score ≥3). A -15% noninferiority margin was assumed.
RESULTS: Data from 88 patients were analyzed, which showed malignant and benign lesions in 84 (95.5%) and four (4.5%) patients, respectively. Of the 88 specimens, 62 (70.5%) and 69 (78.4%) acquired using 25G and 22G needles, respectively, allowed adequate histological assessment. The adjusted proportion difference was -6.6% (95% confidence interval -8.8% to -4.5%), indicating noninferiority of the 25G Franseen needle (P < 0.001). The diagnostic accuracies of the 25G and 22G needles were 86.4% and 89.8%, respectively, with no significant difference (P = 0.180). Adverse events occurred in one patient.
CONCLUSIONS: The 25G Franseen needle showed a noninferior adequate tissue acquisition and similar diagnostic performance compared to that of the 22G Franseen needle. However, a 15% noninferiority margin was high for clinical use; thus, further consideration is needed (Clinical Trial Registry no. UMIN000034596).

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).
To assess the histological material acquisition rate and histological diagnostic capability of the 22-gauge Franseen needle (AC22) during EUS-FNB for solid lesions.
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.
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.
EUS-FNB using AC22 showed high histological diagnostic capability with the high first pass yield.
UMIN Clinical Trials Registry (UMIN ID: UMIN000036641).

OBJECTIVE: Although several techniques for improved outcomes in endoscopic ultrasound (EUS)-guided tissue acquisition have been reported, the reported diagnostic yield for pancreatic masses is not satisfactory. The effects of novel technique (torque method) on twisting the scope in the clockwise or counterclockwise direction during EUS-fine needle biopsy (EUS-FNB) are unknown. We compared the diagnostic yield of EUS-FNB for pancreatic masses using the torque and standard techniques.
METHODS: From April 20, 2017, to March 16, 2018, 124 consecutive patients with solid pancreatic mass who underwent EUS-FNB using either the torque or standard technique were randomly assigned. Three passes were made with each technique, comprising 10 uniform to-and-fro movements on each pass with a 10-mL syringe suction. The primary outcome was procurement rates of histologic cores, and the secondary outcomes were the diagnostic performance and technical failure.
RESULTS: There were significant differences between the groups regarding the procurement rate of the histologic core and optimal quality core (standard vs torque: 87.1% [54/62] vs 98.4% [61/62], P = 0.038 and 79.0% [49/62] vs 93.5% [58/62], P = 0.037). The sensitivity, specificity, positive predictive value, and negative predictive values of EUS-FNB were 85.45%, 100%, 100%, and 46.67%, respectively, for the standard technique and 96.49%, 100%, 100%, and 71.43%, respectively, for the torque technique. The diagnostic accuracies of the standard and torque techniques were 87.10% and 96.77%, respectively.
CONCLUSIONS: The torque technique for EUS-FNB offered acceptable technical feasibility and superior diagnostic performance, including optimal histologic core procurement, compared with the standard technique.

UNASSIGNED: Recently, EUS-guided fine-needle biopsy (EUS-FNB) using a Franseen needle was developed for histological tissue acquisition. However, the yield of a 25G Franseen needle when acquiring histological core tissue has been unclear.
UNASSIGNED: We performed a prospective, multicenter, and observational cohort study that included 100 solid lesions scheduled for EUS-FNB using a 25G Franseen needle at eight centers in Hokkaido, Japan. Only EUS-FNB specimens acquired at the first pass were evaluated without a rapid on-site evaluation. The tissue acquisition rate, acquisition rate of an adequate specimen for histological assessment, the quality of tissue sample, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), diagnostic accuracy, and adverse events were evaluated.
UNASSIGNED: We analyzed a total of 100 solid lesions in 100 patients. The patients were 57 males and 43 females with a median age of 70 years. The technical success rate was 100%. The tissue acquisition rate was 95.0%. The acquisition rate of an adequate specimen for histological assessment was 82.0%. The sensitivity, specificity, PPV, NPV, and diagnostic accuracy were 87.0%, 100%, 100%, 40.0%, and 88.0%, respectively. The adverse event rate was 1.0%, and it was reported in only one patient who had a moderate pancreatic fistula.
UNASSIGNED: EUS-FNB using the 25G Franseen needle was feasible, and adequate histological core tissue samples were acquired with this method.

OBJECTIVE: Procurement of tissue core biopsy may overcome some of the limitations of EUS-FNA. We aimed at assessing the safety, core procurement yield and diagnostic accuracy of two novel available histology needles.
METHODS: Data from consecutive patients with solid lesions who underwent EUS-FNB using the 25G-22G SharkCore™ needles were retrieved from 4 tertiary-care centers database.
RESULTS: 146 patients (mean age 64 ± 12 years; M/F, 76/68) with 156 lesions (114 pancreatic) were identified. In 83 cases the 22G needle was used. 3.6 ± 1.2 passes per lesion were performed, without any major complications. A core biopsy was procured in 89.1% of cases. Considering malignant vs. non-malignant disease, the sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, and diagnostic accuracy were 90.2% (95% CI, 83.7-94.3), 100% (95% CI, 87.2-100), 0.099 (95% CI, 0.058-0.170), 60.4 (95% CI, 3.86-947.4), and 92.3% (95% CI, 88.1-96.5). Procurement yield was significantly higher for the 22G (95.2% vs. 82.2%, p = 0.011), despite the fact that more needle passes were performed with the 25G needle (3.8 ± 1.3 vs. 3.4 ± 1.0, p = 0.028).
CONCLUSIONS: EUS-FNB using the 25G-22G SharkCore™ needles is able to reach a very good procurement yield and diagnostic accuracy. The 22G-size needle showed superior core procurement and diagnostic capabilities. Large prospective studies are warranted to further evaluate the use of these types of needles.

OBJECTIVE: Procurement of tissue core biopsy samples may overcome some of the limitations of endoscopic ultrasound (EUS)-guided fine-needle aspiration. We aimed at assessing the safety, histological sample procurement yield, and diagnostic accuracy of a newly available histology needle.
METHODS: Data from consecutive patients with pancreatic solid lesions who underwent EUS-fine needle biopsy (EUS-FNB) using the 22-gauge Acquire™ needle were retrospectively retrieved from four tertiary care centers database.
RESULTS: Fifty-nine patients (mean age 68 ± 12 years; male/female 29/30) with pancreatic solid lesions underwent EUS-FNB using the 22-gauge Acquire™ needle. The biopsy was done transgastrically in 22 (37.3%) patients and transduodenally in 37 (62.7%) cases. A mean of 2.8 ± 0.45 needle passes per lesion site were performed, without any major complication. A tissue core biopsy sample for histological evaluation was obtained in 55 (93.2%) cases. In the additional four cases, the specimen obtained resulted adequate for cytological evaluation. Considering malignant versus nonmalignant disease, sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, and diagnostic accuracy were 98.2% (95% confidence interval [CI], 90.6-99.7), 100% (95% CI, 43.6-100), 0.018 (95% CI, 0.003-0.125), 295.6 (95% CI, 0-9.3 × 1010), and 98.3% (95% CI, 94.9-100), respectively.
CONCLUSIONS: EUS-FNB using the 22-gauge Acquire™ needle is able to reach a very high procurement yield and diagnostic accuracy. Large prospective studies are warranted to further evaluate the utility of this newly developed needle.