Back to Trials
NCT07100379NARecruiting

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

Boston Children's Hospital

Start Date

10/28/2025

Completion Date

6/24/2028

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.

Eligibility Criteria

Age Range: No minimum to 18 years

Inclusion Criteria: * Diagnosed with esophageal atresia with and without tracheoesophageal fistula, surgically repaired esophageal atresia, esophageal anastomotic strictures requiring endoscopic balloon dilation, and at least 1 endoscopic balloon dilation for esophageal anastomotic strictures within a 6 month period. Exclusion Criteria: * Patients who need endoscopic incisional therapy to manage anastomotic stricture during their first follow up endoscopy, patients requiring administration of intralesional steroid within 4 weeks of repair, have no follow up endoscopy within 6 months period, have any anastomosis type other than esophago-esophageal (e.g. jejunal or colonic interposition), and/or failure to meet target dilation time.

Interventions

PROCEDURE

Endoscopic Balloon Dilation

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Esophageal Atresia With Tracheo-esophageal FistulaEsophageal AtresiaEsophageal Strictures

Locations

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States