Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.

NCT07560462 | Not Yet Recruiting

• 1 other identifier: Budesonide following EBD
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Stricture

Keywords

EBD; esophageal stricture; Oral viscous budesonide

Outcome Measures

Primary Outcomes (1)

• The number of EBD procedures required to achieve clinical success.

  The number of endoscopic balloon dilatation (EBD) procedures required to achieve clinical success (defined as effective swallowing without dysphagia or dietary restriction for 3 months) will be compared between the Budesonide and control groups.

  From the first dilation up to 6 months after the initial dilation.

Secondary Outcomes (6)

• Restenosis rate 6 months after last EBD performed

  Up to 6 months after the last dilation.

• Rate of refractory strictures

  Up to 5 months from the initial dilatation, or until the 7th dilatation, whichever occurs first.

• Patient Weight

  Up to 6 months after the last dilation.

• Dysphagia score

  From baseline until 6 months following the last dilation.

• Pre-dilatation stricture diameter at each procedure

  From baseline until final dilation, on average 6 months following the first.

Study Arms (2)

Budesonide arm

EXPERIMENTAL

Patients will take budesonide gel (1mg/8mL) 250mcg orally twice daily for 12 weeks from the first dilatation.

Drug: Budesonide intervention

Control arm

NO INTERVENTION

Patients will not receive any treatment following their dilations.

Interventions

Budesonide intervention DRUG

Patients will receive budesonide gel (1mg/8mL) 250mcg orally twice daily for 12 weeks from the first dilatation.

Budesonide arm

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead
• European Society of Pediatric Gastroenterology, Hepatology and Nutrition: collaborator

Study Sites (1)

Shaare Zedek Medical Centre

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Esophageal Stenosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Oren Leder, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oren Ledder, Dr

CONTACT

+972-2-6666743; orenl@szmc.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Oren Ledder, Principal Investigator

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)