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Introduction: Anastomotic stricture is a common complication following esophageal atresia (EA) repair, substantially affecting the patient's quality of life (QoL). Multiple dilations are often required to maintain the appropriate diameter of the esophagus, leading to ongoing challenges. The aim of this study is to assess the efficacy of oral viscous budesonide (OVB) in prolonging the time between symptom recurrence and subsequent dilation. Methods: We carried out a retrospective single-center study for pediatric patients (0-18 years) who had undergone recurrent esophageal dilations (=3) following EA repair and initiated treatment with OVB (1 mg/day <10 years, otherwise 2 mg/day). Efficacy of treatment was determined by assessing a dysphagia symptom score (DSS) =1 for at least 3 months. Recurrence time to dysphagia and dilation were analyzed according to Kaplan-Meier method. Results: Of 29 patients screened, 19 were enrolled: 19/19 were responsive to OVB and 13/19 (68%) didn't required further dilations. The median time between dilations was significantly prolonged compared to the pre-treatment period [30 months vs 2months; p<0.01] as well as the time to dysphagia relapse [18months vs 1 month; p<0.01]. Conclusion: Topical budesonide has proven to be an effective treatment for recurrent esophageal stricture in repaired EA. Further investigation is required to assess the long-term sustained response of symptoms to topical steroids. [ABSTRACT FROM AUTHOR]

Background and study aims Currently available polyethylene glycol (PEG)-based preparations continue to represent a challenge in children. The aim of this study was to compare the efficacy and safety of a new low-volume PEG preparation with a conventional PEG-electrolyte solution (PEG-ES) in children and adolescents. Patients and methods This was a multicenter, randomized, observer-blind, parallel-group, phase 3 clinical trial, where patients were randomized between PMF104 (Clensia) and a conventional PEG-ES (Klean-Prep), and stratified by age stratum (2 to <6; 6 to < 12;12 to <18 years). The primary endpoint was to test the non-inferiority of PMF104 versus PEG-ES, in terms of colon cleansing. Safety, tolerability, acceptability, palatability, and compliance were also assessed. Efficacy endpoints were analyzed in the per protocol set (PPS) and full analysis set (FAS) and safety and tolerability endpoints in the safety set (SAF). Results Of the 356 patients enrolled, 258 were included in the PPS, 346 in the FAS, and 351 in the SAF. Non-inferiority of PMF104 was confirmed for children aged > 6 years and for all age groups in PPS and FAS, respectively. Optimal compliance was reported more frequently in the PMF104 than in the PEG-ES group, in both PPS (86.1% vs. 68.4%) and FAS (82.9% vs. 65.3%). Both preparations were equally safe and tolerable. Palatability and acceptability were considered better in the PMF104 group than in the PEG-ES group (27.1% vs. 15.3% and 15.3% vs. 3.5%, respectively). Conclusions In children aged 6 to 17 years, the new low-volume product PMF104 is non-inferior to the reference PEG-ES in terms of bowel cleansing, safety, and tolerability, with slightly better results in compliance, palatability, and acceptability., Competing Interests: Conflict of Interest AlfaSigma has funded this clinical trial with grants provided to the trial sites. Michela Padovani, Raffaella Tacchi and Fabio Cenci are Alfasigma employees. The remaining authors have no other conflict of interest to declare., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)