An interventional study of Endoscopic Balloon Dilation in Esophageal Atresia With Tracheo-esophageal Fistula, Esophageal Atresia and Esophageal Strictures, sponsored by Boston Children's Hospital. Recruiting at 2 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
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.
37 studies on the registry are indexed under Esophageal Atresia; 12 are open to participants now.
This study's planned enrollment of 128 is above the median of 50 across 17 interventional studies indexed under Esophageal Atresia.
Browse Esophageal Atresia studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are randomized into Group A will undergo endoscopic balloon dilation for a total of 30 seconds.
Procedure: Endoscopic Balloon Dilation
Patients randomized into Group B will undergo endoscopic balloon dilation for a duration of 180 seconds.
Procedure: Endoscopic Balloon Dilation
Endoscopic balloon dilation is a routine procedure in which a catheter with a balloon is introduced into the esophagus to help treat esophageal strictures via endoscope. The catheter is placed directly across the span of the esophageal stricture and the balloon is inflated to pre-determined volume in order to dilate the esophageal stricture. Balloon will remain inflated for either 30 or 180 seconds based on patient's randomization.
Stricture response to endoscopic balloon dilation
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.
Time frame: 6 months
Change in esophageal anastomotic diameter
Secondary outcome measures will include esophageal anastomotic diameter at the conclusion of the study period compared to starting esophageal diameter.
Time frame: 6 months
Plan to share: No — Individual participant data will not be shared. Individual data will not provide us with an overall understanding of the efficacy of endoscopic ballon dilation, which is the primary goal of our study. This study will focus on analyzing the results obtained from the cohort as a whole and the results obtained from that analysis will be shared as part of a future manuscript.
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