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Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study
Sponsor: Boston Children's Hospital
Summary
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.
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2025-09-01
Completion Date
2027-06-24
Last Updated
2025-08-03
Healthy Volunteers
No
Interventions
Endoscopic Balloon Dilation
Endoscopic balloon dilation is a routine procedure in which a catheter with a balloon is introduced into the esophagus to help treat esophageal strictures via endoscope. The catheter is placed directly across the span of the esophageal stricture and the balloon is inflated to pre-determined volume in order to dilate the esophageal stricture. Balloon will remain inflated for either 30 or 180 seconds based on patient's randomization.