Study on Triamcinolone Acetonide Injections to Prevent Esophageal Strictures in Children with Esophageal Atresia

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What is this study about?

This clinical trial is focused on studying a condition known as esophageal atresia, which is a birth defect where a baby is born with an incomplete esophagus. After surgical repair, some children may develop a problem called strictures, which are narrowings in the esophagus that can make swallowing difficult. The study aims to find out if using a treatment called intralesional steroid injections can help prevent these strictures from becoming difficult to treat, known as refractory strictures. The medication used in this study is called triamcinolone acetonide, which is given as an injection directly into the affected area.

The purpose of the study is to see if these injections can reduce the number of procedures needed to widen the esophagus, called dilatations, over a period of 28 days. Children who have undergone surgery for esophageal atresia and are experiencing strictures may receive either the steroid injection or a placebo. The study will monitor the number of dilatations each child needs during the study period, which lasts for six months after the initial treatment.

Participants in the study will receive the treatment through a local injection, which means the medication is delivered directly to the site where it is needed. The study will help determine if this approach can effectively reduce the need for repeated procedures and improve the quality of life for children with esophageal atresia. The trial is known as the STEPS-EA trial and is being conducted to gather important information that could benefit future patients with this condition.

1 joining the study

Upon joining the study, ensure that written informed consent is provided by both parents or legal representatives, if applicable.

Eligibility includes being a child with esophageal atresia type C who underwent primary surgery shortly after birth, being at least 3 months old, and requiring a third or fourth dilatation.

2 initial assessment

An initial assessment will be conducted to confirm eligibility and gather baseline health information.

This assessment helps in understanding the current condition and planning the treatment schedule.

3 treatment administration

The treatment involves intralesional steroid injections using a medication called triamcinolone acetonide.

The medication is administered through a local injection directly into the affected area.

The dosage and frequency of the injections will be determined by the medical team based on individual needs.

4 monitoring and follow-up

Regular monitoring will occur to assess the effectiveness of the treatment and to check for any side effects.

Follow-up appointments will be scheduled to evaluate progress and make any necessary adjustments to the treatment plan.

5 evaluation of outcomes

The primary goal is to determine if the injections can prevent the development of strictures and reduce the need for further dilatations within a 28-day interval.

The total number of dilatations required during the study period, which lasts up to 6 months, will be recorded and analyzed.

Who Can Join the Study?

  • Children with EA type C who had surgery to connect the esophagus within the first days of life.
  • Age 3 months or older at the time of the study procedure.
  • In need of a 3rd or 4th procedure to widen the esophagus.
  • Both parents or legal representatives must provide written informed consent.

Who Cannot Join the Study?

  • Patients who have not had a repair for esophageal atresia. Esophageal atresia is a condition where the esophagus, the tube that carries food from the mouth to the stomach, does not form properly.
  • Patients who do not have strictures after the repair. A stricture is a narrowing of the esophagus that can make it difficult to swallow.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Lund University Hospital Lund Sweden
Karolinska University Hospital Solna Sweden
Odense University Hospital Odense Denmark
Roskilde University Roskilde Denmark
Hgudzgyd Uebodomomu Cdzkyqq Hcazapvh Helsinki Finland
Ehdglrz Ujyqrqjzssuz Mwvmslr Crmbokh Rhwammzxz (tkjvyod Mle Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
28.10.2019
Finland Finland
Recruiting
28.10.2019
France France
Not yet recruiting
28.10.2019
Sweden Sweden
Recruiting
28.10.2019
The Netherlands The Netherlands
Recruiting
28.10.2019

Trial locations

Investigated drugs:

Intralesional Steroid Injections are a type of treatment where steroids are directly injected into a specific area of the body. In this clinical trial, the injections are used in children with a condition called esophageal atresia, which affects the esophagus, the tube that carries food from the mouth to the stomach. The goal of these injections is to prevent the formation of strictures, which are narrowings in the esophagus that can make it difficult to swallow. By preventing these strictures, the treatment aims to reduce the number of procedures needed to widen the esophagus.

Investigated diseases:

Esophageal Strictures after Esophageal Atresia Repair – This condition occurs when there is a narrowing of the esophagus following surgical repair of esophageal atresia, a congenital defect where the esophagus does not form properly. The narrowing, or stricture, can develop as scar tissue forms at the site of the surgical repair. This can lead to difficulty swallowing, as food and liquids may not pass easily through the narrowed section of the esophagus. Over time, the stricture may become more pronounced, potentially requiring medical intervention to alleviate symptoms. The progression of this condition can vary, with some individuals experiencing more frequent or severe symptoms than others. Regular monitoring is often necessary to manage the condition effectively.

Trial ID:
2023-504905-36-00
Protocol code:
NL65364.078.18
Trial Phase:
Human Pharmacology (Phase I) – Other

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