Balloon inflation time for esophageal narrowing after atresia repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized multi-center trial compares different balloon inflation durations during endoscopic dilation for esophageal anastomotic strictures in children who have had repair of esophageal atresia. Participants at Boston Children's Hospital and Children's Hospital of Philadelphia are assigned to specified inflation times and are followed for outcomes such as need for repeat dilation, symptom relief, and procedural complications over a six-month period. Eligible patients must have esophago-esophageal anastomotic strictures requiring dilation and at least one dilation within a six-month window, while patients needing incisional therapy, recent intralesional steroid, non-esophageal interposition, or who cannot meet target dilation time are excluded. The study tests whether inflation time influences clinical success, safety, and frequency of additional procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed with esophageal atresia with and without tracheoesophageal fistula, surgically repaired esophageal atresia, esophageal anastomotic strictures requiring endoscopic balloon dilation, and at least 1 endoscopic balloon dilation for esophageal anastomotic strictures within a 6 month period.

Exclusion Criteria:

* Patients who need endoscopic incisional therapy to manage anastomotic stricture during their first follow up endoscopy, patients requiring administration of intralesional steroid within 4 weeks of repair, have no follow up endoscopy within 6 months period, have any anastomosis type other than esophago-esophageal (e.g. jejunal or colonic interposition), and/or failure to meet target dilation time.

Where it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Jessica Yasuda, MD — Boston Children's Hospital
• Study coordinator: Jessica Yasuda, MD
• Email: Jessica.Yasuda@childrens.harvard.edu
• Phone: 617-355-3038

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.