Balloon inflation time for esophageal narrowing after atresia repair
Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study
This trial will try different balloon inflation times during endoscopic dilation to see which works best for children with narrowing after esophageal atresia repair.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT07100379 on ClinicalTrials.gov |
What this trial studies
This randomized multi-center trial compares different balloon inflation durations during endoscopic dilation for esophageal anastomotic strictures in children who have had repair of esophageal atresia. Participants at Boston Children's Hospital and Children's Hospital of Philadelphia are assigned to specified inflation times and are followed for outcomes such as need for repeat dilation, symptom relief, and procedural complications over a six-month period. Eligible patients must have esophago-esophageal anastomotic strictures requiring dilation and at least one dilation within a six-month window, while patients needing incisional therapy, recent intralesional steroid, non-esophageal interposition, or who cannot meet target dilation time are excluded. The study tests whether inflation time influences clinical success, safety, and frequency of additional procedures.
Who should consider this trial
Good fit: Children with surgically repaired esophageal atresia who have esophago-esophageal anastomotic strictures requiring endoscopic balloon dilation and who can undergo at least one dilation within a six-month period are ideal candidates.
Not a fit: Patients who require endoscopic incisional therapy, have received intralesional steroids within four weeks, have non-esophageal interposition anastomoses, or cannot meet the study's target dilation time or follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If a particular inflation duration leads to better long-term widening, children may need fewer repeat dilations, less anesthesia exposure, and fewer clinic visits.
How similar studies have performed: Balloon dilation is a standard treatment for strictures and some adult series suggest inflation technique matters, but randomized pediatric data directly comparing inflation durations are lacking.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jessica Yasuda, MD — Boston Children's Hospital
- Study coordinator: Jessica Yasuda, MD
- Email: Jessica.Yasuda@childrens.harvard.edu
- Phone: 617-355-3038
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.