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NCT Number: NCT07100379

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

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.

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Key information

Conditions

Esophageal Atresia With Tracheo-esophageal Fistula Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Esophageal Atresia Esophageal Diseases Esophageal Stenosis Esophageal Strictures Esophageal atresia with or without tracheoesophageal fistula Gastrointestinal Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic Balloon Dilation

Procedure

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.

Primary outcomes

  1. Stricture response to endoscopic balloon dilation

    Time frame: 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 outcomes

  1. Change in esophageal anastomotic diameter

    Time frame: 6 months

    Secondary outcome measures will include esophageal anastomotic diameter at the conclusion of the study period compared to starting esophageal diameter.

Study contacts

Contact information is provided by the study sponsor or research team.

James Orozco, DO

CONTACT

[email protected]

Jessica Yasuda, MD

CONTACT

[email protected]

617-355-3038

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Acronym: BITES

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 3, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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