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Objective: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is the first-line technique for the sampling of pancreatic lesions. Many factors can influence the diagnostic performance of this procedure, including the use of rapid on-site evaluation (ROSE). The primary aim of this study was to compare the adequacy, diagnostic yield, accuracy, sensitivity and specificity of EUS-FNA for solid pancreatic lesions before and after the introduction of ROSE. Methods: This retrospective single-centre study evaluated all consecutive patients who underwent EUS-FNA for suspicious, solid pancreatic masses from April 2012 to March 2015. We compared the findings of EUS-FNA procedures performed during the first and second years following the adoption of ROSE (“ROSE1” and “ROSE2”, respectively) to those performed the year before ROSE introduction (the “pre-ROSE” group). Results: Ninety-one consecutive patients with a total of 93 pancreatic lesions were enrolled. For the pre-ROSE, ROSE1 and ROSE2 groups, the adequacy rates were 96.2%, 96.6% and 100%, the diagnostic yield values were 76.9%, 89.7% and 92.1% and accuracy values were 69.2%, 86.2% and 89.5% (p = NS). Sensitivity for malignancy improved from 63.7% in the pre-ROSE group to 91.7% and 91.2% in the post-ROSE groups (p < 0.05). Specificity for malignancy was 100% in all groups. Conclusions: ROSE can improve the diagnostic performance of EUS-FNA for solid pancreatic lesions, although only sensitivity reached statistical significance.

This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H2 and CH4. Therefore, the SATISFACTION study, an international, multicenter, randomized, parallel-group phase II–III study investigated this issue. The phase II dose-finding part of the study evaluated H2, CH4, and O2 concentrations in 179 patients randomized to treatment with 50 g, 100 g, or 150 g mannitol. Phase III of the study compared the presence of intestinal gases in 680 patients randomized (1:1) to receive mannitol 100 g in single dose or a standard split-dose 2 L polyethylene glycol (PEG)-Asc preparation (2 L PEG-Asc). Phase II results showed that mannitol did not influence the concentration of intestinal gases. During phase III, no patient in either group had H2 or CH4 concentrations above the critical thresholds. In patients with H2 and/or CH4 levels above detectable concentrations, the mean values were below the risk thresholds by at least one order of magnitude. The results also highlighted the effectiveness of standard washing and insufflation maneuvers in removing residual intestinal gases. In conclusion, bowel cleansing with mannitol was safe as the concentrations of H2 and CH4 were the same as those found in patients prepared with 2 L PEG-Asc. In both groups, the concentrations of gases were influenced more by the degree of cleansing achieved and the insufflation and washing maneuvers performed than by the preparation used for bowel cleansing. The trial protocol was registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885) and with EudraCT (eudract_number: 2019-002856-18).

Objective: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is the first-line technique for the sampling of pancreatic lesions. Many factors can influence the diagnostic performance of this procedure, including the use of rapid on-site evaluation (ROSE). The primary aim of this study was to compare the adequacy, diagnostic yield, accuracy, sensitivity and specificity of EUS-FNA for solid pancreatic lesions before and after the introduction of ROSE. Methods: This retrospective single-centre study evaluated all consecutive patients who underwent EUS-FNA for suspicious, solid pancreatic masses from April 2012 to March 2015. We compared the findings of EUS-FNA procedures performed during the first and second years following the adoption of ROSE (“ROSE1” and “ROSE2”, respectively) to those performed the year before ROSE introduction (the “pre-ROSE” group). Results: Ninety-one consecutive patients with a total of 93 pancreatic lesions were enrolled. For the pre-ROSE, ROSE1 and ROSE2 groups, the adequacy rates were 96.2%, 96.6% and 100%, the diagnostic yield values were 76.9%, 89.7% and 92.1% and accuracy values were 69.2%, 86.2% and 89.5% (p = NS). Sensitivity for malignancy improved from 63.7% in the pre-ROSE group to 91.7% and 91.2% in the post-ROSE groups (p < 0.05). Specificity for malignancy was 100% in all groups. Conclusions: ROSE can improve the diagnostic performance of EUS-FNA for solid pancreatic lesions, although only sensitivity reached statistical significance.

This study aimed to define the pharmacokinetics (PKs) of oral mannitol used as an osmotic laxative for bowel preparation for colonoscopy. The PKs of oral mannitol was evaluated in a substudy as part of a phase II dose-finding, international, multicenter, randomized, parallel-group, endoscopist-blinded study. Patients were randomly assigned to take 50, 100, or 150 g mannitol. Venous blood samples were drawn at baseline (T0), 1 h (T1), 2 h (T2), 4 h (T4), and 8 h (T8) after completion of mannitol self-administration. The mean mannitol plasma concentrations (mg/ml) were dose-dependent with a consistent difference among doses. The mean maximum concentration (Cmax) ± SD was 0.63 ± 0.15, 1.02 ± 0.28, and 1.36 ± 0.39 mg/ml, in the three dosage groups, respectively. The mean area under the curve from zero to infinity (AUC0−∞) was 2.667 ± 0.668, 4.992 ± 1.706, and 7.403 ± 3.472 mg/ml*h in the 50, 100, and 150 g mannitol dose groups, respectively. Bioavailability was similar in the three dose groups and was just over 20% (0.243 ± 0.073, 0.209 ± 0.081, and 0.228 ± 0.093 in the 50, 100, and 150 g mannitol dose groups, respectively). The present study showed that the bioavailability of oral mannitol is just over 20% and is similar for the three tested doses (50, 100, and 150 g). The linear increase in Cmax, AUC0−t8, and AUC0−∞ must be considered when choosing the oral mannitol dose for bowel preparation to avoid its systemic osmotic effects.

Goals: The present survey from the Italian Society of Digestive Endoscopy (SIED-Società Italiana di Endoscopia Digestiva) was aimed at reporting infection control practice and outcomes at Digestive Endoscopy Units in a high-incidence area. Background: Lombardy was the Italian region with the highest coronavirus disease-2019 (COVID-19) prevalence, at the end of March 2020 accounting for 20% of all worldwide deaths. Joint Gastro-Intestinal societies released recommendations for Endoscopy Units to reduce the risk of the contagion. However, there are few data from high-prevalence areas on adherence to these recommendations and on their efficacy. Methods: A survey was designed by the Lombardy section of SIED to analyze (a) changes in activity and organization, (b) adherence to recommendations, (c) rate of health care professionals' (HCP) infection during the COVID-19 outbreak. Results: In total, 35/61 invited centers (57.4%) participated; most modified activities were according to recommendations and had filtering face piece 2/filtering face piece 3 and water-repellent gowns available, but few had negative-pressure rooms or provided telephonic follow-up; 15% of HCPs called in sick and 6% had confirmed COVID-19. There was a trend (P = 0.07) toward different confirmed COVID-19 rates among endoscopists (7.9%), nurses (6.6%), intermediate-care technicians (3.4%), and administrative personnel (2.2%). There was no correlation between the rate of sick HCPs and COVID-19 incidence in the provinces and personal protective equipment availability and use, whereas an inverse correlation with hospital volume was found. Conclusions: Adherence to recommendations was rather good, though a minority were able to follow all recommendations. Confirmed COVID-19 seemed higher among endoscopists and nurses, suggesting that activities in the endoscopy rooms are at considerable viral spread risk.