NCT07100379

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Atresia With Tracheo-esophageal Fistula
• Esophageal Atresia
• Esophageal Strictures

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-06-24
• Completion: 2027-06-24
• First posted: 2025-08-03
• Last updated: 2025-08-03