Is intralesional steroid injection effective in treating recurrent stricture following reconstruction of esophageal malformation in children?
Phase 1
- Conditions
- Recurrent anastomotic strictures in the esophagus following surgical repair with primary anastomosis of esophageal atresia in neonates.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2022-003287-25-SE
- Lead Sponsor
- Erasmus University Medical Center - Sophia Childrens Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
Children with esophageal atresia type C (Gross C, the most common form) repaired with primary anastomosis, that are considered for a third dilatation
Are the trial subjects under 18? yes
Number of subjects for this age range: 110
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Children < 3 months of age.
2. No informed consent obtained prior to intervention
3. Not suitable for endoscopic procedure using standard pediatric endoscopic equipment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This study aims to provide evidence regarding the beneficial effect of local steroid injection in anastomotic strictures following reconstructed esophageal atresia. The specific research questions are: (1) do intralesional steroid injection prevent refractory strictures in children with EA, and (2) do intralesional steroid injection reduce the number of dilatations needed?;Secondary Objective: Secondary aims include the treatment effect on dysphagia, stricture characteristics, serum cortisol levels and potential systemic effects of steroid injection, co-medication and cost-benefit analysis.;Primary end point(s): The primary outcome parameter is the total number of dilatations per patient within 28 days interval required during the study period, defined as the period from the day of the 3rd dilatation until 6 months later.;Timepoint(s) of evaluation of this end point: Evaluation of primary outcome will be 6 months after intervention.
- Secondary Outcome Measures
Name Time Method