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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50430

Enrollment

Registered

2018-12-11

Start date

2019-10-24

Completion date

Unknown

Last updated

2024-09-09

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

Conditions

narrowing esophagus stricture after esophageal atresia

Interventions

Children assigned to the intervention group will be treated with ISI preliminary to the 3rd dilatation. Children assigned to the control group will undergo dilatation without any injections.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - Children with EA type C who underwent primary anastomotic surgery - Age >=3 months at the time of the 3rd dilatation - In need of a 3rd dilatation - Written informed consent by both parents or guardians if applicable

Exclusion criteria

Exclusion criteria: - Age

Design outcomes

Primary

Measure	Time frame
The primary outcome parameter is the total number of dilatations within 28 days interval needed per patient during the study period, i.e. from the day of the 3rd dilatation until 6 months later.	—

Secondary

Measure	Time frame
The secondary outcome parameters are: 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 relative change in length of the esophageal stricture after the 3rd dilatation compared to the length before the 3rd dilatation. 6) The use of co-medication (e.g. antacids) during the study period. 7) 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. 8) Total costs of the treatment, including medical and non-medical costs. 9) Incremental costs per refractory stricture prevented and incremental costs per additional dysphagia-free patient.	—

Measure

Time frame

The secondary outcome parameters are: 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 relative change in length of the esophageal stricture after the 3rd dilatation compared to the length before the 3rd dilatation. 6) The use of co-medication (e.g. antacids) during the study period. 7) 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. 8) Total costs of the treatment, including medical and non-medical costs. 9) Incremental costs per refractory stricture prevented and incremental costs per additional dysphagia-free patient.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)