STEPS-EA trial: Esophageal Atresia
With Dr. Anfleur von Hall · EUPSA/ERNICA
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Esophageal Atresia 52 items
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What the experts said
The STEPS-EA trial is an international multi-center randomized control trial initiated by the Sophia Children's Hospital in Rotterdam with cooperation from the European Reference Network ERICA.
The standard treatment for esophageal atresia is surgery with an end-to-end anastomosis to restore continuity.
Stricture formation remains the most frequent post-operative complication in more than half of esophageal atresia cases.
The current standard treatment for esophageal stricture is endoscopic dilatation either by bouginage or by balloon dilatation.
Worldwide, balloon dilatation is most frequently used for esophageal strictures, which is why it has been chosen as the standard procedure for the intervention in this study.
Intralesional steroid injections are an adjuvant treatment to endoscopic dilatation, where mostly triamcinolone is used.
Steroids are thought to inhibit the formation of collagen, enhance its breakdown, and decrease fibrotic healing, thereby inhibiting scar formation and making stenosis less likely to recur.
Each of the four quadrants of the stricture will be injected with steroid.
The trial will investigate three main topics: effectiveness, safety, and cost-effectiveness of intralesional steroid injection.
110 children born with esophageal atresia are needed to prove the effectiveness of the steroid injection.
Study group A will be injected with triamcinolone and then undergo balloon dilatation, while study group B will only undergo balloon dilatation as part of standard of care.
All patients undergo an esophagram prior to dilatation as part of standard of care.
A second esophagram will be performed to objectify the effectiveness of the intervention on the length and diameter of the stricture.
Physical length and weight will be measured at 4 time points throughout the 6-month study period to investigate possible systemic side effects of a single dose steroid injection.
At the end of the follow-up period, a small scale hair sample will be collected to measure cortisol levels to investigate possible systemic effects and 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.