Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.

This single-blinded randomized controlled trial aims to prospectively evaluate the efficacy of swallowed budesonide gel following EBD of esophageal strictures. Due to the variable nature of congenital strictures and the more disparate features of caustic and EoE strictures, the study is limited to simple strictures at the site of anastomoses.

Patients will be assessed as per the ESPGHAN and NASPGHAN guidelines for the evaluation and treatment of children with esophageal atresia-trachoesophageal fistula, with gastroscopy performed either at one-year of age or earlier in symptomatic patients with dysphagia.

Patients in whom an anastomotic esophageal stricture is identified, dilatations will be performed as per physician discretion regarding diameter and timing of dilatations, guided predominantly by the aforementioned treatment guidelines. Patients will be randomly assigned to either budesonide gel (1mg/8mL) 250mcg orally twice daily for 12 weeks from the first dilatation, or to standard of care with no oral budesonide. Treating physician will be blinded to patient treatment Esophageal stricture characteristics will be recorded at each endoscopy with pre-dilation diameter (estimated based on relative size to pre-measured biopsy forceps placed in proximity to the stricture) and maximal dilatation diameter at each session.

Patients will be assessed clinically routinely at 1, 2, 3, 4 and 6 months following initial dilatation, and at 6 months following the last dilatation in the series, during which dysphagia symptom score and patient weight will be assessed.

Success is defined as restoration of effective swallow with no dysphagia or age-appropriate dietary restrictions for 3 months. Outcome measures will include number of EBD procedures until success is achieved, as well as the rate of restenosis (defined clinically as a dysphagia score of ≥1) after success is achieved 6 months following the last EBD procedure.

The primary aim of the study is to assess the number of dilatations required to achieve clinical success between the treatment and placebo group. Secondary aims include rate of refractory strictures, restenosis rate, dysphagia score, patient weight and safety (including cortisol suppression, oral or esophageal fungal infection, and anthropomorphics).

Inclusion criteria

• Infants and children < 12 years old with an anastomotic esophageal stricture following repair of congenital esophageal atresia / tracheoesophageal fistula
• Dysphagia score ≥1
• Parental consent

Exclusion criteria

• Additional stricture/s besides anastomotic stricture eg. Congenital stricture
• Complicated stricture - including length >2cm, significant angulation or irregularity
• Neurological impairment or other cause of expected limitation to oral intake
• Previous anastomotic dilatations
• Complicated surgical course including need for re-operation, re-fistularization or surgical anastomotic leak
• Suspected or verified thoracic vascular anomaly affecting esophageal patency or function
• Verified co-diagnosis of eosinophilic esophagitis
• Any contraindication to EBD according to treating physician's planned treatment course