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

Esophageal Atresia Clinical Trial

— OVB in EA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03999008
• Other study ID #: OVB in EA
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2019
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Stenosis
• Constriction, Pathologic
• Esophageal Atresia

Intervention

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.
• Placebos
Apple Sauce 5 mL+ 1 mL saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of dilations needed after randomization (beginning of treatment)	number of dilations needed after randomization (beginning of treatment)	12 months
Secondary	Number of patients needing dilation after randomization (beginning of treatment)	Number of patients needing dilation after randomization (beginning of treatment)	12 months
Secondary	Number of patients needing more than 3 dilations after randomization	Number of patients needing more than 3 dilations after randomization	12 months
Secondary	Mean time to further dilation	Mean time to further dilation	12 months
Secondary	Number of patients treated with an adjuvant therapy	Number of patients treated with an adjuvant therapy	12 months
Secondary	Ability to tolerate normal food for age	Ability to tolerate normal food for age	12 months
Secondary	Dysphagia score	Dysphagia score	12 months
Secondary	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
Secondary	Side effects/Adverse events	Side effects/Adverse events	12 months