Search

Simple Summary: There is limited literature on sample adequacy for molecular testing and genomic sequencing for pancreatic ductal adenocarcinoma obtained via EUS fine-needle aspiration (FNA) versus EUS fine-needle biopsy (FNB). Thus, we aimed to compare these two modalities regarding sample adequacy for molecular testing and genomic sequencing. In this retrospective chart review study, we analyzed all patients with pancreatic ductal adenocarcinoma who underwent EUS at Saint Luke's Hospital, Kansas City, MO, from 1 January 2018, to 31 December 2021. A rapid on-site evaluation was performed for all cases by cytotechnologists. We found that out of 1417 EUS procedures, 132 patients underwent EUS-guided biopsies. The mean number of passes required for FNB and FNA was similar. However, EUS-FNB, under rapid on-site specimen evaluation guidance, was superior to FNA in obtaining adequate samples for molecular testing. In addition, tumor surface area and tumor cellularity are essential parameters in determining sample adequacy for molecular testing, regardless of the tissue acquisition modality. Background and Aims: There is limited literature on sample adequacy for molecular testing in pancreatic ductal adenocarcinoma obtained via endoscopic ultrasound (EUS) fine-needle aspiration (FNA) versus EUS fine-needle biopsy (FNB). We aimed to compare these two modalities regarding sample adequacy for molecular and genomic sequencing. Methods: We reviewed all patients with pancreatic ductal adenocarcinoma who underwent EUS at Saint Luke's Hospital from 2018 to 2021. The patients were categorized based on the method of EUS tissue acquisition, specifically FNA or FNB. A comprehensive evaluation was conducted for all cases by cytotechnologists. Results: Out of 132 patients who underwent EUS-guided biopsies, 76 opted for FNA, 48 opted for FNB, and 8 opted for a combination of both. The average number of passes required for FNB and FNA was 2.58 ± 1.06 and 2.49 ± 1.07, respectively (p = 0.704), indicating no significant difference. Interestingly, 71.4% (35) of FNB-obtained samples were deemed adequate for molecular testing, surpassing the 32.1% (26) adequacy observed with FNA (p < 0.001). Additionally, 46.4% (26) of FNB-obtained samples were considered adequate for genomic testing, a notable improvement over the 23.8% (20) adequacy observed with FNA (p = 0.005). Conclusion: Although the number of passes required for cytologic diagnosis did not differ significantly between EUS-FNB and EUS-FNA, the former demonstrated superiority in obtaining samples adequate for molecular testing. Tumor surface area and cellularity were crucial parameters in determining sample adequacy for molecular testing, irrespective of the chosen tissue acquisition modality. [ABSTRACT FROM AUTHOR]

Objective: Evaluate safety and efficacy of the pose™ procedure for obesity treatment.Methods: Subjects with Class I to II obesity were randomized (2:1) to receive active or sham procedure, after each investigator performed unblinded lead-in cases. All subjects were provided low-intensity lifestyle therapy. Efficacy end points were the mean difference in percent total body weight loss (%TBWL) at 12 months between randomized groups, and responder rate achieving ≥5% TBWL. The primary safety end point was incidence of reported adverse events.Results: Three hundred thirty-two subjects were randomized (active, n = 221; sham, n = 111); thirty-four subjects were included in the unblinded lead-in cohort. Twelve-month results were mean TBWL 7.0 ± 7.4% in lead-in, 4.95 ± 7.04% in active, and 1.38 ± 5.58% in sham groups, respectively. Responder rate was 41.55% in active and 22.11% in sham groups, respectively (P < 0.0001); mean responder result was 11.5% TBWL. The differences observed between active and sham groups for co-primary end points were statistically significant (P < 0.0001); however, super superiority margin as set forth in the study design was not met. No unanticipated adverse events or deaths occurred. Procedure-related serious adverse event rates were 5.0% (active) and 0.9% (sham), P = 0.068.Conclusions: The pose procedure was safe and resulted in statistically significant and clinically meaningful weight loss over sham through 1 year. [ABSTRACT FROM AUTHOR]