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

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Atresia; Anastomotic Stenosis
• Intervention / Treatment: Drug: Budesonide Oral; Drug: Placebos

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Budesonide; Oral viscous budesonide will be given in apple sauce according to body weight at inclusion: < 10 kg: 250 mcg BID in 5 ml apple sauce 10 kg to <15 kg: 500 mcg BID in 5 ml apple sauce >15 kg: 1000 mcg BID in 5 ml apple sauce	Drug: Budesonide Oral; The subjects will be included at time of the first dilation for an anastomotic stricture. Basal physical exam and clinical evaluation (weight and height, dysphagia score, gastroesophageal reflux, feeding problems, respiratory symptoms, other symptoms). Randomization will be conducted by centre. Because long gap esophageal atresia, high tension anastomosis and history of anastomotic leak are reported as risk factors for occurrence of anastomotic strictures, a stratification at randomization will be performed according to these criteria in each centre. OVB or placebo will be given by the parents and started the day of the dilation at the first meal after recovering of the dilation and anesthesia. Parents will be asked to bring the empty caps which will be counted for assessment of compliance.
Placebo Comparator: Placebo; Placebo: 5 ml apple sauce BID plus 1 mL saline	Drug: Placebos; Apple Sauce 5 mL+ 1 mL saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of dilations needed after randomization (beginning of treatment)	number of dilations needed after randomization (beginning of treatment)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients needing dilation after randomization (beginning of treatment)	Number of patients needing dilation after randomization (beginning of treatment)	12 months
Number of patients needing more than 3 dilations after randomization	Number of patients needing more than 3 dilations after randomization	12 months
Mean time to further dilation	Mean time to further dilation	12 months
Number of patients treated with an adjuvant therapy	Number of patients treated with an adjuvant therapy	12 months
Ability to tolerate normal food for age	Ability to tolerate normal food for age	12 months
Dysphagia score	Dysphagia score	12 months
Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age	Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age	12 months
Side effects/Adverse events	Side effects/Adverse events	12 months

Collaborators and Investigators

• Sponsor: St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Digestive System Abnormalities; Constriction, Pathologic; Esophageal Atresia; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: OVB in EA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No