STEPS-EA trial
Phase 1
- Conditions
- Strictures after esophageal atresia repairTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
Children with EA type C who underwent primary anastomotic surgery within the first days of life, Age =3 months at the time of the 3rd dilatation, In need of a 3rd dilatation, Written informed consent by both parents or legal representatives, if applicable
Exclusion Criteria
Age <3 months, Known inability from previous dilatations to use an endoscope with a size of 5.8 mm, No parental written informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to find out whether intralesional steroid injections (ISI) in children with esophageal atresia (EA) can prevent refractory strictures from developing and consequently can reduce the total number of dilatations needed within 28 days interval.;Secondary Objective: To compare the level of dysphagia, To compare the efficacy of the effect of dilatation with ISI on the luminal esophageal diameter and the stricture length, To evaluate a possible influence of co-medication on stricture formation, To analyze the possible systemic effects of ISI, To analyze the costs-effectiveness of the intervention between the two groups.;Primary end point(s): The total number of dilatations within 28 days interval needed per patient during the study period, i.e. from the day of the 3rd dilatation until 6 months later.
- Secondary Outcome Measures
Name Time Method