Recruiting

Balloon Dilation

Sponsor:

Boston Children's Hospital

Code:

NCT07100379

Conditions

Esophageal Atresia With Tracheo-esophageal Fistula

Esophageal Atresia

Esophageal Strictures

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Endoscopic Balloon Dilation

Study Details

Brief summary:

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.

Conditions

Esophageal Atresia With Tracheo-esophageal Fistula

Esophageal Atresia

Esophageal Strictures

Study ID

NCT07100379

Start date

Oct 28, 2025

Status verified date

Jul, 2025

Completion date

Jun 24, 2028

Anticipated

Primary completion date

Jun 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A (30 seconds)

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

experimental: Group B (180 seconds)

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

Interventions

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.

Primary outcome measure

  • Stricture response to endoscopic balloon dilation [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jessica Yasuda, MD

617-355-3038Jessica.Yasuda@childrens.harvard.edu

James Orozco, DO

james.orozco@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jessica Yasuda, MD

jessica.yasuda@childrens.harvard.edu

James Orozco, DO

james.orozco@childrens.harvard.edu

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Michael Manfredi, MD

manfredim@chop.edu

Rosa Hwang

HWANGR3@chop.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Apr 30, 2026

Last verified

Jul, 2025

Keywords

  • endoscopic balloon dilation
  • post-surgical correction
  • esophageal strictures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-04-30.