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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

N/A - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Endoscopic Balloon Dilation — PROCEDURE
  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.

Study Details

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 Dates

Start date

Oct 28, 2025

Status verified

Jul 2025

Primary completion

Jun 24, 2027

Completion

Jun 24, 2028

Study Design

Enrollment

128 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group A (30 seconds)
  Patients who are randomized into Group A will undergo endoscopic balloon dilation for a total of 30 seconds.
• Experimental: Group B (180 seconds)
  Patients randomized into Group B will undergo endoscopic balloon dilation for a duration of 180 seconds.

Primary Outcome Measure

Stricture response to endoscopic balloon dilation [ Time Frame: 6 months ]

Central Contacts

• Jessica Yasuda, MD
  617-355-3038
  [email protected]
• James Orozco, DO
  [email protected]

Locations (2)

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