Prevention of recurrent narrowing of the esophagus after correction of esophageal atresia by injecting steroids

Intralesional steroid injections to prevent refractory strictures in patinets with esophageal atresia - a randomized controlled trial - STEPS-EA trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002863-24-FI

Enrollment

110

Registered

2019-07-03

Start date

2019-09-11

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

Recurrent stenosis after correction of esophageal atresia

Interventions

Trade Name: Kenacort A-10 Product Name: Kenacort A-10 Product Code: 01591 Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The following patients are eligible for the study: - 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: 110 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The following patients are excluded from the study: - 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: The primary objective is to find out whether intralesional steroid injections in children with esophageal atresia can prevent refractory strictures from developing and consequently can reduce the total number of dilatations needed within 28 days interval. ;Secondary Objective: The secondary objectives are: -To compare between the two groups the level of dysphagia and the child’s eating behavior at the end of the follow up period. -To compare between the two groups the efficacy of dilatation with or without intralesional steroid injections on the luminal diameter and the stricture length. -To evaluate a possible influence of co-medication (e.g. antacids) on stricture formation. -To analyze the possible systemic effects of a one-time intralesional steroid injection. -To analyze the cost-effectiveness of the use of intralesional steroid injections to prevent refractory strictures. ;Primary end point(s): The primary outcome parameter is the 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: Six months after the intervention	—

Measure

Time frame

Main Objective: The primary objective is to find out whether intralesional steroid injections in children with esophageal atresia can prevent refractory strictures from developing and consequently can reduce the total number of dilatations needed within 28 days interval. ;Secondary Objective: The secondary objectives are: -To compare between the two groups the level of dysphagia and the child’s eating behavior at the end of the follow up period. -To compare between the two groups the efficacy of dilatation with or without intralesional steroid injections on the luminal diameter and the stricture length. -To evaluate a possible influence of co-medication (e.g. antacids) on stricture formation. -To analyze the possible systemic effects of a one-time intralesional steroid injection. -To analyze the cost-effectiveness of the use of intralesional steroid injections to prevent refractory strictures. ;Primary end point(s): The primary outcome parameter is the 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: Six months after the intervention

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Secondary

Measure	Time frame
Secondary end point(s): The secondary outcome parameters are: Total number of dilatations within the study period, regardless of the interval. Interval (in weeks) between the start of the study and the last dilatation procedure within the study period. Montreal Feeding Scale (in Dutch Screeningslijst Eetgedrag Peuters (SEP)), measured at the end of the follow up period. The relative change in maximal luminal diameter after the 3rd dilatation compared to the diameter before the 3rd dilatation. The relative change in length of the esophageal stricture after the 3rd dilatation compared to the length before the 3rd dilatation. The use of co-medication (e.g. antacids) during the study period. 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. Total costs of the treatment, including medical and non-medical costs. Incremental costs per refractory stricture prevented and incremental costs per additional dysphagia-free patient. Ad 2) The start of the study is defined as the day of the intervention, i.e. the interval is between the date of the 3rd dilatation and the date of the final dilatation. Ad 3) This scale has been validated and used in previous research in children with EA [41-43]. Ad 4, 5) Prior to the 3rd dilatation an esophagram is made to quantify the stricture, as standard of care. Two to three weeks after the 3rd dilatation another esophagram is made. This applies to both the intervention as the control group. An anterior-posterior and a lateral X-ray will be taken with the use of contrast. The diameter will be determined at the narrowest point of the esophagus. The length will be determined between the two points where the esophageal diameter starts narrowing. The diameter and length will be determined in both anterior-posterior and lateral direction. Earlier studies have proven that this is quite feasible from an esophagram [40]. All esophagrams	—

Measure

Time frame

Secondary end point(s): The secondary outcome parameters are: Total number of dilatations within the study period, regardless of the interval. Interval (in weeks) between the start of the study and the last dilatation procedure within the study period. Montreal Feeding Scale (in Dutch Screeningslijst Eetgedrag Peuters (SEP)), measured at the end of the follow up period. The relative change in maximal luminal diameter after the 3rd dilatation compared to the diameter before the 3rd dilatation. The relative change in length of the esophageal stricture after the 3rd dilatation compared to the length before the 3rd dilatation. The use of co-medication (e.g. antacids) during the study period. 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. Total costs of the treatment, including medical and non-medical costs. Incremental costs per refractory stricture prevented and incremental costs per additional dysphagia-free patient. Ad 2) The start of the study is defined as the day of the intervention, i.e. the interval is between the date of the 3rd dilatation and the date of the final dilatation. Ad 3) This scale has been validated and used in previous research in children with EA [41-43]. Ad 4, 5) Prior to the 3rd dilatation an esophagram is made to quantify the stricture, as standard of care. Two to three weeks after the 3rd dilatation another esophagram is made. This applies to both the intervention as the control group. An anterior-posterior and a lateral X-ray will be taken with the use of contrast. The diameter will be determined at the narrowest point of the esophagus. The length will be determined between the two points where the esophageal diameter starts narrowing. The diameter and length will be determined in both anterior-posterior and lateral direction. Earlier studies have proven that this is quite feasible from an esophagram [40]. All esophagrams

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Countries

Denmark, Finland, France, Netherlands

Contacts

Public Contactproject leader

Erasmus MC

c.tenkate@erasmusmc.nl+31107036116

Outcome results

None listed

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