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

Launched by BOSTON CHILDREN'S HOSPITAL · Jul 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat narrowing (called strictures) that can happen after surgery to repair a condition called esophageal atresia, where the esophagus (the tube that carries food from the mouth to the stomach) doesn’t develop properly. After surgery, many children develop these narrow spots, which can make swallowing difficult. Doctors often use a procedure called balloon dilation to widen the narrowed area by inflating a small balloon inside the esophagus. This study aims to find out if the amount of time the balloon is kept inflated makes a difference in how well the treatment works.

Children and adults who have had surgery for esophageal atresia and have developed narrowing that requires balloon dilation may be eligible to participate. Participants need to have had at least one balloon dilation in the past six months and meet certain other criteria. During the study, participants will undergo balloon dilation as part of their usual care, and the time the balloon is inflated will be carefully studied to see if it affects healing and swallowing. This study is not yet recruiting, but it hopes to help doctors improve treatment for people with this condition in the future.

Gender

ALL

Eligibility criteria

• 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.