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

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Justine's Hospital
• Treatments: Budesonide

Criteria

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