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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

Intralesional Steroid Injections – This medication is administered directly into the tissue at the site of a problem, specifically through injections. It is currently being studied in clinical trials to determine its effectiveness in preventing strictures, which are narrowings that can occur after surgical repair of esophageal atresia, a condition where the esophagus does not form properly. The main therapeutic use being investigated is to prevent these strictures from becoming severe and to reduce the need for additional procedures to widen the esophagus. At the molecular level, steroids work by reducing inflammation and suppressing the immune response, which can help prevent the formation of scar tissue that leads to strictures. This medication falls under the pharmacological classification of corticosteroids, which are commonly used to reduce inflammation in various medical conditions.

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 detailsLast updated 7 Oct 2026
Age0-17PhasePhase ITrial ID2023-504905-36-00Protocol codeNL65364.078.18Estimated enrolment110 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

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