STEPS-EA trial: Esophageal Atresia

Hello, my name is Anfleur von Hall, and I'm one of the coordinating investigators of the SECA trial. In this short 3 minute video, I will explain the aim of our study and how the SEP CA trial will be performed. The SEP CA trial stands for intralesional steroid injections to prevent refractory strictures in patients with esophageal atresia and is an international multi-center randomized control trial. The SEP CA is initiated by the Sophia Children's Hospital in Rotterdam with close cooperation with the European Reference Network ERICA. As you know, the standard treatment for oesophageal atricia is surgery with an end to end anastomosis to restore continuity. However, stricture formation remains the most frequent post-operative complication in more than half of the cases. Currently, the standard treatment for oesophageal stricture is endoscopic dilatation either by bouginage or by balloon dilatation. Worldwide, the balloon is most frequently used, which is why this has been chosen as a standard procedure for the intervention in this study, leaving open all other dilatations for own preferences. With the intervention, we hope to prevent the development of refractory stricture. An adjuvant treatment to endoscopic dilatation is intralesional steroid injections, where mostly quinacort is used. It is thought that these steroids inhibit the formation of collagen, enhances its breakdown, and decreases the fibrotic healing. Scar formation will therefore be inhibited, and the stenosis will be less likely to recur. This video shows an endoscopic injection of an esophageal stricture. Each of the four quadrants of the stricture will be injected like this. Together with you, we want to investigate three main topics the effectiveness, the safety, and the cost effectiveness of this intervention. 110 children born with esophageal atresia are needed to prove the effectiveness of the steroid injection. Patients will be randomized into two study groups. The study group A will be injected with Ginnacort and then undergo balloon dilatation. Study Group B will not be injected and will only undergo balloon dilatation. As part of the standard of care. All patients undergo an esophagram prior to dilatation. For this study, a second esophagram will be performed to objectify the effectiveness of the intervention on the length and diameter of the stricture. To investigate the possible systemic side effects of a single dose steroid injection, we will measure physical length and weight at 4 time points throughout the 6 month study period. At the end of the follow-up period, a small scale hair sample will be collected to measure the cortisol levels to investigate the possible systemic effects and therefore the safety of the intralesional steroid injection. During the follow-up period, parents will be asked to fill out an online questionnaire about disease-related expenses and dysphagia. This is the Steps CA trial in a nutshell. Thanks to the Sophia Children's Hospital Funds, we are happy to tell you that each center will receive €750 for each inclusion to cover the extra costs made while taking part in the trial. Different members and affiliated partners of the Ernica have shown interest or are taking part in our trial. We are very happy to cooperate with these centers and are always willing to welcome more participating centers. We hope we've sparked your enthusiasm about this unique trial. If you have any questions or if you would like to participate, please let us know by sending us an email. We are more than happy to help you.