Randomized trial comparing 15 vs 5 actuations per pass during endoscopic ultrasound-guided fine-needle biopsy for specimen acquisition of solid pancreatic lesions.

BACKGROUND AND AIM: There is currently no established number of actuations (to-and-fro movements) per pass during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB). This study aimed to compare 15 vs 5 actuations in terms of adequate specimen acquisition of solid pancreatic lesions. METHODS: In this prospective, randomized, crossover, noninferiority, single-center study, eligible patients underwent EUS-FNB using a 22-G Franseen needle with both 15 and 5 actuations per pass, performed in a randomized order, from October 2020 to December 2021. The acquired specimens from each pass were separately evaluated. The primary outcome was the accuracy of the histological diagnosis per pass. The noninferiority margin was set as 15%. RESULTS: Data from 85 patients were analyzed, revealing pancreatic cancer in 73 patients. The accuracy of the histological diagnosis in the 15 and 5 actuations groups was 83.5% (71/85) and 77.7% (66/85), respectively. The difference was -5.8% (95% confidence interval -15.6-3.4), which does not indicate noninferiority of the five actuations group. Among the secondary outcomes, the 15 actuations group was significantly superior to the five actuations group in terms of the obtained core tissues (1.88 [interquartile range 0.89-3.64] mm2 vs 1.66 [0.83-2.71] mm2 [P = 0.031]) and subjective evaluation of cytology specimens for pancreatic cancer (69.0% vs. 31.0%, P = 0.005). CONCLUSIONS: The noninferiority of five actuations in the accuracy of the histological diagnosis was not confirmed, and 15 actuations are preferred during EUS-FNB for solid pancreatic lesions.

Usefulness of Macroscopic On-Site Evaluation Using a Stereomicroscope during EUS-FNB for Diagnosing Solid Pancreatic Lesions.

METHODS: We reviewed a total of 60 consecutive patients who underwent both S-MOSE and rapid on-site cytopathological evaluation (ROSE) during EUS-FNB between July 2019 and October 2020, and the usefulness of S-MOSE in comparison with histology was evaluated. A 22-gauge Franseen needle was used to perform EUS-FNB in all patients, and only the specimens obtained by the first pass were evaluated. The final diagnosis was based on the surgical specimen or the clinical course consistent with the EUS-FNB results. RESULTS: The final diagnoses of the 60 patients included 45 patients with pancreatic ductal adenocarcinoma, 6 with autoimmune pancreatitis, 4 with mass-forming pancreatitis, 1 with pancreatic metastasis, 2 with pancreatic neuroendocrine tumor, and 2 with intraductal papillary mucinous carcinoma. The histological diagnostic accuracy of the first pass of EUS-FNB was 83.3% (50/60). The agreement between the S-MOSE and the histological diagnosis was 90% (54/60). The positive predictive value of S-MOSE for histological diagnosis was 90.7%, which can be an indicator of when to stop the EUS-FNB procedure. There were no immediate or delayed adverse events reported after the FNB based on the chart and medical visit history review. CONCLUSION: In the EUS-FNB of SPLs, S-MOSE can be an alternative to ROSE for specimen evaluation and has the potential to shorten the procedure time.

Randomized controlled trial on timing and number of sampling for bile aspiration cytology.

BACKGROUND: The issue on timing and number of bile sampling for exfoliative bile cytology is still unsettled. METHODS: A total of 100 patients with cholangiocarcinoma undergoing resection after external biliary drainage were randomized into two groups: a 2-day group where bile was sampled five times per day for 2 days; and a 10-day group where bile was sampled once per day for 10 days (registered University Hospital Medical Information Network/ID 000005983). The outcome of 87 patients who underwent laparotomy was analyzed, 44 in the 2-day group and 43 in the 10-day group. RESULTS: There were no significant differences in patient characteristics between the two groups. Positivity after one sampling session was significantly lower in the 2-day group than in the 10-day group (17.0 ± 3.7% vs. 20.7 ± 3.5%, P = 0.034). However, cumulative positivity curves were similar and overlapped each other between both groups. The final cumulative positivity by the 10th sampling session was 52.3% in the 2-day group and 51.2% in the 10-day group. We observed a small increase in cumulative positivity after the 5th or 6th session in both groups. CONCLUSIONS: Bile cytology positivity is unlikely to be affected by sample time.