Intralesional Steroid Injections to Prevent Refractory Strictures in Patients with Esophageal Atresia – a randomized controlled trial (STEPS-EA)

This is an international multicentre single-blinded randomised controlled trial with two arms: injection prior to balloon dilatation and single dilatation without any injection. One hundred and ten children with EA type C will be recruited within the framework of an European Reference Network. After the indication for dilatation has been determined with an oesophagram, the intervention will take place at time of the 3rd dilatation. During a follow up period of six months, patients will undergo an oesophagram, length and weight will be measured, a scalp hair sample will be collected and parents will be invited to fill out three questionnaires. The primary outcome parameter is the total number of dilatations within 28 days interval needed per patient during the study period. Secondary outcome parameters include the level of dysphagia, the luminal esophageal diameter and stricture length as measured on the oesophagrams, influence of co-medication, systemic effects of TAC (cortisol levels, length and weight) and the cost-effectiveness. The primary outcome parameter will be analysed with a linear-by-linear chi-square association test.

We hypothesize that the application of intralesional steroid injections in esophageal strictures in children with esophageal atresia could prevent the occurrence of refractory strictures and reduce the total number of dilatations by 50% in this population.

Outcome: total number of dilatations, time point: 6 months
Outcome: interval untill last dilatation, time point: 6 months
Outcome: Montreal Feeding Scale, time point: 6 months
Outcome: change in diameter en stricture length, time point: 3 weeks
Outcome: use of co-medication, time point: 6 months
Outcome: cortisol level, time point: 6 months
Outcome: total costs, time point: 6 months

Injection with 10mg triamcinolone acetonide (1mL Kenacort-A 10)