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

Esophageal atresia (EA) is one of the most common gastrointestinal congenital anomalies that affects 1 in 2500 to 1 in 4000 live births. It is characterized by abnormal development of the esophagus, which requires surgical intervention to be compatible with life. Surgical repair of EA is associated with risk of developing esophageal strictures or narrowing, which nearly affects 40% of cases. Strictures can be treated using endoscopic balloon dilation, which consists of introducing a catheter with a balloon into the esophagus via endoscopy and positioning it across stricture followed by balloon inflation. The inflated balloon is held in position for a set amount of time with the goal to dilate the narrowed area. At this time there are no pediatric studies comparing difference balloon dilation times and outcomes. Our study's goal is to evaluate balloon dilation inflation time in treating esophageal anastomotic strictures to understand if inflation time is associated with outcome.

NCT Number	NCT07100379
Lead Sponsor	Boston Children's Hospital Collaborators: Children's Hospital of Philadelphia
Conditions	Esophageal Atresia With Tracheo-esophageal Fistula, Esophageal Atresia, Esophageal Strictures
Enrollment	128 participants
Start Date	2025-10-28
Primary Completion	2027-06-24 (estimated)
Study Completion	2028-06-24 (estimated)
Updated on ClinicalTrials.gov	2026-04-30