Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA)

A Multicentre, Prospective, Randomized, Placebo Controlled, Double-blinded Study to Demonstrate Potential and Beneficial Effects of Oral Viscous Budesonide (OVB) in the Prevention of Recurrence of Anastomotic Stricture in Children Operated on for Esophageal Atresia With Recurrent Anastomotic Strictures

The aim of this study is to perform a multicentre, prospective, randomized, placebo controlled, double-blinded study to demonstrate the potential and beneficial effects of OVB in the prevention of recurrence of anastomotic stricture in children operated for esophageal atresia with an anastomotic stricture.

Inclusion Criteria:

• Children aged > 1 month to 3 years

• Operated for an esophageal atresia of all types except pure TEF.

• Presence of an anastomotic stricture defined according to experts recommendations :

  • a relative esophageal narrowing at the level of the anastomosis,
  • demonstrated by a contrast study and/or an endoscopy
  • with significant functional impairment and associated symptoms requiring dilation.
  • Symptoms include: feeding or swallowing difficulties, coughing and choking during feeds, food impaction, regurgitation/vomiting of undigested food, drooling. In very young patients: apnea and food refusal.

• Receiving an ongoing treatment by PPI 1 to 2 mg/kg die

• Informed parental consent

Exclusion Criteria:

• Known immune deficiency
• Acute respiratory or intestinal infection
• Severe respiratory, cardiac or neurological condition precluding OVB or placebo swallowing
• Child fed exclusively via nasogastric tube or gastrostomy
• Absence of parental consent