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

Phase 3

Recruiting

• Conditions: narrowing esophagus; stricture after esophageal atresia; 10018008

• Registration Number: NL-OMON50430
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter is the total number of dilatations within 28 days<br /><br>interval needed per patient during the study period, i.e. from the day of the<br /><br>3rd dilatation until 6 months later. </p><br>