Intraoperative visualisation and treatment of salivary glands in Sjögren's syndrome by contrast-enhanced ultrasound sialendoscopy (CEUSS):protocol for a phase I single-centre, single-arm, exploratory study

INTRODUCTION: We established a promising sialendoscopic treatment for in vivo enhancement of salivation in salivary glands affected by Sjögren's syndrome (SS). In this technique, the ducts of the salivary glands are irrigated with saline and steroids. This allows for dilatation of ductal strictures and removal of debris. Unfortunately, it is not possible to assess the delivery and penetration of saline or medications in the ductal system and parenchyma. To address this problem, we will conduct contrast-enhanced ultrasound sialendoscopy (CEUSS) using sulphur hexafluoride microbubbles. To the best of our knowledge, microbubbles have never been used for the treatment of salivary glands in SS. It is, therefore, imperative to test this application for its safety and feasibility. METHODS AND ANALYSIS: A single-arm phase I study will be performed in 10 SS patients. Under local anaesthesia, ultrasound (US) guided infusion of the parotid and submandibular glands with microbubbles will be performed. Continuous US imaging will be used to visualise the glands, including the location of strictures and occlusions. Main outcomes will be the evaluation of safety and technical feasibility of the experimental treatment. Secondary outcomes will consist of determinations of unstimulated whole mouth saliva flow, stimulated whole mouth saliva flow, stimulated parotid saliva flow, clinical oral dryness, reported pain, xerostomia, disease activity, salivary cytokine profiles and clinical SS symptoms. Finally, salivary gland topographical alterations will be evaluated by US. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the Medical Ethics Committee of the Amsterdam University Medical Centre, Amsterdam, The Netherlands (NL68283.029.19). data will be presented at national and international conferences and published in a peer-reviewed journal. The study will be implemented and reported in line with the Standard Protocol Items: Recommendations for Interventional Trials' statement. TRIAL REGISTRATION NUMBERS: The Netherlands Trial Register: NL7731, MREC Trial Register: NL68283.029.19; Pre-results

Sialendoscopy increases saliva secretion and reduces xerostomia up to 60 weeks in Sjogren's syndrome patients:a randomized controlled study

OBJECTIVE: To assess the effect of sialendoscopy of the major salivary glands on salivary flow and xerostomia in patients with Sjögren's syndrome (SS). METHODS: Forty-five patients with SS were randomly assigned to a control group (no irrigation, control, n = 15), to irrigation of the major salivary glands with saline (saline, n = 15) or to irrigation with saline followed by corticosteroid application (triamcinolone acetonide in saline, saline/TA, n = 15). Unstimulated whole saliva flow (UWSF), chewing-stimulated whole saliva flow (SWSF), citric acid-stimulated parotid flow, Clinical Oral Dryness Score (CODS), Xerostomia Inventory (XI) and EULAR SS Patient Reported Index (ESSPRI) scores were obtained 1 week before (T0), and 1, 8, 16, 24, 36, 48 and 60 weeks after sialendoscopy. Data were analysed using linear mixed models. RESULTS: Irrespective of the irrigation protocol used, sialendoscopy resulted in an increased salivary flow during follow-up up to 60 weeks. Significant between-group differences in the longitudinal course of outcomes were found for UWSF, SWSF, XI and ESSPRI scores (P = 0.028, P = 0.001, P = 0.03, P = 0.021, respectively). UWSF at 60 weeks was higher compared with T0 in the saline group (median: 0.14 vs median: 0.10, P = 0.02) and in the saline/TA group (median: 0.20, vs 0.13, P = 0.035). In the saline/TA group SWSF at 48 weeks was higher compared with T0 (median: 0.74 vs 0.38, P = 0.004). Increase in unstimulated salivary flow was also reflected in improved CODS, XI and ESSPRI scores compared with baseline. CONCLUSION: Irrigation of the major salivary glands in patients with SS increases salivary flow and reduces xerostomia

Impact Evaluation of Wet-Weather Events on Influent Flow and Loadings of a Water Resource Recovery Facility

Since the introduction of environmental legislation and directives in Europe, the impact of combined sewer overflows (CSO) on receiving water bodies has become a priority concern in water and wastewater treatment industry. Time-consuming and expensive local sampling and monitoring campaigns have been carried out to estimate the characteristic flow and pollutant concentrations of CSO water. This study focused on estimating the frequency and duration of wet-weather events and their impacts on influent flow and wastewater characteristics of the largest Italian water resource recovery facility (WRRF) in Castiglione Torinese. Eight years (viz. 2009–2016) of routinely collected influent data in addition to the arithmetic mean daily precipitation rates (PI) of the plant catchment area, were elaborated. Relationships between PI and volumetric influent flow rate (Qin), chemical oxygen demand (COD), ammonium concentration (N-NH4) and total suspended solids (TSS) are investigated. Time series data mining (TSDM) method is implemented for segmentation of time series by use of sliding window algorithm to partition the available records associated with wet and dry weather events based on the daily variation of PI time series. Appling the methodology in conjunction with results obtained from data reduction techniques, a wet-weather definition is proposed for the plant. The results confirm that applied methodology on routinely collected plant data can be considered as a good substitute for time-consuming and expensive sampling campaigns and plant monitoring programs usually conducted for accurate emergency response and long-term preparedness for extreme climate conditions