Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.

Starting soon · Not applicable

Conditions studied: Esophageal Stricture

In brief

Endoscopic balloon dilatation (EBD) is a common therapeutic procedure performed for esophageal strictures. While the etiologies of esophageal strictures are numerous - including congenital strictures, caustic injuries and eosinophilic esophagitis (EoE) -anastomotic strictures following esophageal atresia and trachea-esophageal fistula repairs is reported as the most frequent cause in children. Stricture dilatation is usually performed under direct endoscopic vision, with graduated balloon dilatation, utilizing increasing balloon diameters deployed until reaching a pre-determined, age-based, dilatation target. Balloon dilatation is repeated every 2-4 weeks until the target is reached. Success is defined as prolonged restoration of effective swallow with no dysphagia or dietary restrictions. Dilatation is repeated if clinical resolution is not obtained, or if symptoms return after initial resolution. In children, a stricture is considered refractory when the age-appropriate esophageal lumen is not achieved with five dilatations within 5 months, or if despite ≥7 dilatations overall an age-appropriate esophageal lumen was not maintained. Several interventions have been studied to improve the efficacy of balloon dilatation, including injecting corticosteroids at the dilatation site, topical Mitomycin C following dilatation, or pre-dilatation endoscopic incisions of the anastomotic scar tissue. All these interventions are performed endoscopically at the time of the dilatation, require advanced endoscopic skills and may potentially have associated additional risk. In this study the investigators aim to test the efficacy and safety of topical budesonide gel following EBD for anastomotic esophageal strictures in a single-blinded, randomized controlled study of children.

Key facts

Study ID

NCT07560462

Run by

Shaare Zedek Medical Center

People needed

32

Starts

2026-05-01

Expected to finish

2029-05-01

Last updated by the study team

2026-05-01

Who can join

Age: any, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Shaare Zedek Medical Centre — Jerusalem, Israel

Full record on ClinicalTrials.gov

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