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.
clinicalThe 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.↗
▶Ep 46 · 0:00
quoteHello, my name is Anfleur von Hall, and I'm one of the coordinating investigators of the SECA trial.↗
▶Ep 46 · 0:20
quoteThe 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.↗
▶Ep 46 · 0:40
clinicalThe standard treatment for esophageal atresia is surgery with an end-to-end anastomosis to restore continuity.↗
▶Ep 46 · 0:55
quotestricture formation remains the most frequent post-operative complication in more than half of the cases.↗
▶Ep 46 · 0:55
epidemiologicalStricture formation remains the most frequent post-operative complication in more than half of esophageal atresia cases.↗
▶Ep 46 · 1:10
clinicalThe current standard treatment for esophageal stricture is endoscopic dilatation either by bouginage or by balloon dilatation.↗
▶Ep 46 · 1:20
clinicalWorldwide, 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.↗
▶Ep 46 · 1:35
clinicalIntralesional steroid injections are an adjuvant treatment to endoscopic dilatation, where mostly triamcinolone is used.↗
▶Ep 46 · 1:45
clinicalSteroids 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.↗
▶Ep 46 · 1:45
quoteIt is thought that these steroids inhibit the formation of collagen, enhances its breakdown, and decreases the fibrotic healing.↗
▶Ep 46 · 1:55
clinicalEach of the four quadrants of the stricture will be injected with steroid.↗
▶Ep 46 · 2:00
clinicalThe trial will investigate three main topics: effectiveness, safety, and cost-effectiveness of intralesional steroid injection.↗
▶Ep 46 · 2:10
clinical110 children born with esophageal atresia are needed to prove the effectiveness of the steroid injection.↗
▶Ep 46 · 2:18
clinicalStudy 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.↗
▶Ep 46 · 2:35
clinicalAll patients undergo an esophagram prior to dilatation as part of standard of care.↗
▶Ep 46 · 2:42
clinicalA second esophagram will be performed to objectify the effectiveness of the intervention on the length and diameter of the stricture.↗
▶Ep 46 · 2:52
clinicalPhysical 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.↗
▶Ep 46 · 3:03
clinicalAt 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.↗
▶Ep 46 · 3:13
clinicalDuring the follow-up period, parents will be asked to fill out an online questionnaire about disease-related expenses and dysphagia.↗
