Study Comparing Balloon Inflation Durations to Treat Esophageal Narrowing in Children with Esophageal Atresia

What this Trial Is About

Esophageal atresia EA is a common congenital condition affecting the esophagus, requiring surgical repair to survive. This research evaluates the impact of different balloon inflation times during endoscopic balloon dilation, a treatment for esophageal anastomotic stricturesa common complication after surgery that narrows the esophagus. The study aims to understand whether the duration of balloon inflation affects treatment outcomes in pediatric patients. Participants will be randomly assigned to one of two groups. Group A will receive endoscopic balloon dilation with the balloon inflated for 30 seconds, while Group B will have the balloon inflated for 180 seconds. This procedure involves placing a catheter with a balloon at the narrowed esophageal section via endoscopy and inflating it to widen the stricture. The study compares these two inflation times to assess their effects on stricture response. During the study, participants will be monitored over six months to evaluate the response of strictures to the balloon dilation and changes in the diameter of the esophageal anastomosis. Researchers will use follow-up endoscopies to measure these outcomes. The study involves regular assessments to track progress and safety, with the total participation period covering at least six months after the dilation procedure.

Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study