Intralesional steroids injections to prevent refractory strictures in patients with esophageal atresia - a randomized controlled tiral
Phase 1
- Conditions
- refractory strictures in patients with esophageal atresiaMedDRA version: 20.0Level: PTClassification code 10021530Term: Imperforate oesophagusSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2018-002863-24-FR
- Lead Sponsor
- Erasmus Universitu Medical Center - Sophia Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
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
- Age <3 months
- Known inability from previous dilatations to use an endoscope with a size of 5.8 mm
- No parental written informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method