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出境医 / 临床实验 / Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA) (OVB in EA)

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Esophageal Atresia Anastomotic Stenosis Drug: Budesonide Oral Drug: Placebos Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2023
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. number of dilations needed after randomization (beginning of treatment) [ Time Frame: 12 months ]
    number of dilations needed after randomization (beginning of treatment)


Secondary Outcome Measures :
  1. Number of patients needing dilation after randomization (beginning of treatment) [ Time Frame: 12 months ]
    Number of patients needing dilation after randomization (beginning of treatment)

  2. Number of patients needing more than 3 dilations after randomization [ Time Frame: 12 months ]
    Number of patients needing more than 3 dilations after randomization

  3. Mean time to further dilation [ Time Frame: 12 months ]
    Mean time to further dilation

  4. Number of patients treated with an adjuvant therapy [ Time Frame: 12 months ]
    Number of patients treated with an adjuvant therapy

  5. Ability to tolerate normal food for age [ Time Frame: 12 months ]
    Ability to tolerate normal food for age

  6. Dysphagia score [ Time Frame: 12 months ]
    Dysphagia score

  7. Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age [ Time Frame: 12 months ]
    Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age

  8. Side effects/Adverse events [ Time Frame: 12 months ]
    Side effects/Adverse events


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   1 Month to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date June 26, 2019
Estimated Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019) 		number of dilations needed after randomization (beginning of treatment) [ Time Frame: 12 months ]
number of dilations needed after randomization (beginning of treatment)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Number of patients needing dilation after randomization (beginning of treatment) [ Time Frame: 12 months ]
    Number of patients needing dilation after randomization (beginning of treatment)
  • Number of patients needing more than 3 dilations after randomization [ Time Frame: 12 months ]
    Number of patients needing more than 3 dilations after randomization
  • Mean time to further dilation [ Time Frame: 12 months ]
    Mean time to further dilation
  • Number of patients treated with an adjuvant therapy [ Time Frame: 12 months ]
    Number of patients treated with an adjuvant therapy
  • Ability to tolerate normal food for age [ Time Frame: 12 months ]
    Ability to tolerate normal food for age
  • Dysphagia score [ Time Frame: 12 months ]
    Dysphagia score
  • Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age [ Time Frame: 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 [ Time Frame: 12 months ]
    Side effects/Adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Esophageal Atresia
  • Anastomotic Stenosis
Intervention  ICMJE
  • 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.

  • Drug: Placebos
    Apple Sauce 5 mL+ 1 mL saline
Study Arms  ICMJE
  • 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

    Intervention: Drug: Budesonide Oral
  • Placebo Comparator: Placebo
    Placebo: 5 ml apple sauce BID plus 1 mL saline
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2023
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03999008
Other Study ID Numbers  ICMJE OVB in EA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christophe Faure, St. Justine's Hospital
Study Sponsor  ICMJE St. Justine's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account St. Justine's Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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