Anastomotic Stenosis, Esophageal Atresia
Conditions
Brief 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.
Interventions
DRUGBudesonide 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.
DRUGPlacebos
Apple Sauce 5 mL+ 1 mL saline
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 3 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of dilations needed after randomization (beginning of treatment) | 12 months | number of dilations needed after randomization (beginning of treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients needing more than 3 dilations after randomization | 12 months | Number of patients needing more than 3 dilations after randomization |
| Mean time to further dilation | 12 months | Mean time to further dilation |
| Number of patients treated with an adjuvant therapy | 12 months | Number of patients treated with an adjuvant therapy |
| Number of patients needing dilation after randomization (beginning of treatment) | 12 months | Number of patients needing dilation after randomization (beginning of treatment) |
| Dysphagia score | 12 months | Dysphagia score |
| Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age | 12 months | Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age |
| Side effects/Adverse events | 12 months | Side effects/Adverse events |
| Ability to tolerate normal food for age | 12 months | Ability to tolerate normal food for age |
Outcome results
None listed