Actively Recruiting
Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study
Led by Boston Children's Hospital · Updated on 2026-04-30
128
Participants Needed
2
Research Sites
138 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with esophageal atresia with or without tracheoesophageal fistula
- Surgically repaired esophageal atresia
- Esophageal anastomotic strictures requiring endoscopic balloon dilation
- At least 1 endoscopic balloon dilation for esophageal anastomotic strictures within a 6 month period
You will not qualify if you...
- Need for endoscopic incisional therapy to manage anastomotic stricture during first follow-up endoscopy
- Administration of intralesional steroid within 4 weeks of repair
- No follow-up endoscopy within 6 months
- Any anastomosis type other than esophago-esophageal (e.g., jejunal or colonic interposition)
- Failure to meet target dilation time
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
J
Jessica Yasuda, MD
CONTACT
J
James Orozco, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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