Intralesional steroids injections to prevent refractory strictures in patients with esophageal atresia - a randomized controlled tiral

Intralesional steroids injections to prevent refractory strictures in patients with esophageal atresia - a randomized controlled tiral - STEPS-EA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002863-24-FR

Enrollment

110

Registered

2021-02-24

Start date

2021-07-21

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

refractory strictures in patients with esophageal atresia MedDRA version: 20.0 Level: PT Classification code 10021530 Term: Imperforate oesophagus System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Kenacort-A 10 mg-ml Product Name: Kenacort-A Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children with EA type C who underwent primary anastomotic surgery within the first days of life - Age 3 months at the time of the 3rd dilatation - In need of a 3rd dilatation - Written informed consent by both parents or legal representatives, if applicable Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Age <3 months - Known inability from previous dilatations to use an endoscope with a size of 5.8 mm - No parental written informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluate whether intralesional injection with steroids in children with EA can prevent the development of a refractory stricture, and thus can minimize the total number of dilatations within 28 days interval.;Secondary Objective: - compare between the two groups the level of dysphagia and the child’s eating behavior at the end of the follow up period. - compare between the two groups the efficacy of dilatation with or without intralesional steroid injections on the luminal diameter and the stricture length. - evaluate a possible influence of co-medication (e.g. antacids) on stricture formation. - analyze the possible systemic effects of a one-time intralesional steroid injection. - analyze the cost-effectiveness of the use of intralesional steroid injections to prevent refractory strictures.;Primary end point(s): total number of dilatations per patient within 28 days interval required during the study period, defined as the period from the day of the 3rd dilatation until 6 months later.;Timepoint(s) of evaluation of this end point: 28 days	—

Measure

Time frame

Main Objective: evaluate whether intralesional injection with steroids in children with EA can prevent the development of a refractory stricture, and thus can minimize the total number of dilatations within 28 days interval.;Secondary Objective: - compare between the two groups the level of dysphagia and the child’s eating behavior at the end of the follow up period. - compare between the two groups the efficacy of dilatation with or without intralesional steroid injections on the luminal diameter and the stricture length. - evaluate a possible influence of co-medication (e.g. antacids) on stricture formation. - analyze the possible systemic effects of a one-time intralesional steroid injection. - analyze the cost-effectiveness of the use of intralesional steroid injections to prevent refractory strictures.;Primary end point(s): total number of dilatations per patient within 28 days interval required during the study period, defined as the period from the day of the 3rd dilatation until 6 months later.;Timepoint(s) of evaluation of this end point: 28 days

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Secondary

Measure	Time frame
Secondary end point(s): 1) Total number of dilatations within the study period, regardless of the interval. 2) Interval (in weeks) between the start of the study and the last dilatation procedure within the study period. 3) Montreal Feeding Scale (in Dutch Screeningslijst Eetgedrag Peuters (SEP)), measured at the end of the follow up period. 4) The relative change in maximal luminal diameter after the 3rd dilatation compared to the diameter before the 3rd dilatation. 5) The use of co-medication (e.g. antacids) during the study period. 6) The mean cortisol level over the first three months after the 3rd dilatation, measured in a hair sample taken at the end of the follow up period. 7) Total costs of the treatment, including medical and non-medical costs. ;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Secondary end point(s): 1) Total number of dilatations within the study period, regardless of the interval. 2) Interval (in weeks) between the start of the study and the last dilatation procedure within the study period. 3) Montreal Feeding Scale (in Dutch Screeningslijst Eetgedrag Peuters (SEP)), measured at the end of the follow up period. 4) The relative change in maximal luminal diameter after the 3rd dilatation compared to the diameter before the 3rd dilatation. 5) The use of co-medication (e.g. antacids) during the study period. 6) The mean cortisol level over the first three months after the 3rd dilatation, measured in a hair sample taken at the end of the follow up period. 7) Total costs of the treatment, including medical and non-medical costs. ;Timepoint(s) of evaluation of this end point: 6 months

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Countries

Croatia, Denmark, European Union, Finland, France, Lithuania, Netherlands, United Kingdom

Contacts

Public ContactAramatoulaye SAMBOU (ARC

Centre Hopsitalier et universitaire de Lille

DRC@chru-lille.fr00330320444145

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026