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ID
Source
Brief title
Health condition
esophageal atresia, strictures, slokdarmatresie, stricturen, stenose
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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.
Background summary
This is an international multicentre single-blinded randomised controlled trial with two arms: injection prior to balloon dilatation and single dilatation without any injection. One hundred and ten children with EA type C will be recruited within the framework of an European Reference Network. After the indication for dilatation has been determined with an oesophagram, the intervention will take place at time of the 3rd dilatation. During a follow up period of six months, patients will undergo an oesophagram, length and weight will be measured, a scalp hair sample will be collected and parents will be invited to fill out three questionnaires. The primary outcome parameter is the total number of dilatations within 28 days interval needed per patient during the study period. Secondary outcome parameters include the level of dysphagia, the luminal esophageal diameter and stricture length as measured on the oesophagrams, influence of co-medication, systemic effects of TAC (cortisol levels, length and weight) and the cost-effectiveness. The primary outcome parameter will be analysed with a linear-by-linear chi-square association test.
Study objective
We hypothesize that the application of intralesional steroid injections in esophageal strictures in children with esophageal atresia could prevent the occurrence of refractory strictures and reduce the total number of dilatations by 50% in this population.
Study design
Outcome: total number of dilatations, time point: 6 months
Outcome: interval untill last dilatation, time point: 6 months
Outcome: Montreal Feeding Scale, time point: 6 months
Outcome: change in diameter en stricture length, time point: 3 weeks
Outcome: use of co-medication, time point: 6 months
Outcome: cortisol level, time point: 6 months
Outcome: total costs, time point: 6 months
Intervention
Injection with 10mg triamcinolone acetonide (1mL Kenacort-A 10)
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
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
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7484 |
| NTR-old | NTR7726 |
| CCMO | NL65364.078.18 |
| OMON | NL-OMON50430 |