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

Boston Children's Hospital

Status: Not yet enrolling

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

Treatments: Procedure: Endoscopic Balloon Dilation

Study type: Interventional

Funder types: Other

Identifiers

NCT07100379

IRB-P00048288

Details and patient eligibility

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.

Enrollment: 128 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

128 participants in 2 patient groups

Group A (30 seconds)

Experimental group

Description:

Patients who are randomized into Group A will undergo endoscopic balloon dilation for a total of 30 seconds.

Treatment:

Procedure: Endoscopic Balloon Dilation

Group B (180 seconds)

Experimental group

Description:

Patients randomized into Group B will undergo endoscopic balloon dilation for a duration of 180 seconds.

Treatment:

Procedure: Endoscopic Balloon Dilation