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

Not Applicable

Not yet recruiting

• Conditions: Esophageal Atresia With Tracheo-esophageal Fistula; Esophageal Atresia; Esophageal Strictures

• Registration Number: NCT07100379
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-28
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Study Start: 2025-09-01
• Primary Completion: 2027-06-24
• Study Completion: 2027-06-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stricture response to endoscopic balloon dilation	6 months	Study aims to determine whether the efficacy of endoscopic ballon dilation depends on duration of balloon inflation duration and does this influence the need for repeat endoscopic balloon dilations. Response to dilation will be defined by total number of dilations needed to treat stricture in a 6 month period.

Secondary Outcome Measures

Name	Time	Method
Change in esophageal anastomotic diameter	6 months	Secondary outcome measures will include esophageal anastomotic diameter at the conclusion of the study period compared to starting esophageal diameter.