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

NCT07100379 | Recruiting

• 1 other identifier: IRB-P00048288
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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

Keywords

endoscopic balloon dilation; post-surgical correction; esophageal strictures

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Change in esophageal anastomotic diameter

  6 months

Study Arms (2)

Group A (30 seconds)

EXPERIMENTAL

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

Procedure: Endoscopic Balloon Dilation

Group B (180 seconds)

EXPERIMENTAL

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

Procedure: Endoscopic Balloon Dilation

Interventions

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.

Group A (30 seconds); Group B (180 seconds)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: collaborator
• Boston Children's Hospital: lead

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (7)

• Khan AA, Shah SW, Alam A, Butt AK, Shafqat F, Castell DO. Pneumatic balloon dilation in achalasia: a prospective comparison of balloon distention time. Am J Gastroenterol. 1998 Jul;93(7):1064-7. doi: 10.1111/j.1572-0241.1998.00330.x.

  PMID: 9672331 BACKGROUND

• Wallner O, Wallner B. Balloon dilation of benign esophageal rings or strictures: a randomized clinical trial comparing two different inflation times. Dis Esophagus. 2014 Feb-Mar;27(2):109-11. doi: 10.1111/dote.12080. Epub 2013 Apr 26.

  PMID: 23621385 BACKGROUND

• Ten Kate CA, Tambucci R, Vlot J, Spaander MCW, Gottrand F, Wijnen RMH, Dall'Oglio L. An international survey on anastomotic stricture management after esophageal atresia repair: considerations and advisory statements. Surg Endosc. 2021 Jul;35(7):3653-3661. doi: 10.1007/s00464-020-07844-6. Epub 2020 Aug 3.

  PMID: 32748272 BACKGROUND

• Kovesi T, Rubin S. Long-term complications of congenital esophageal atresia and/or tracheoesophageal fistula. Chest. 2004 Sep;126(3):915-25. doi: 10.1378/chest.126.3.915.

  PMID: 15364774 BACKGROUND

• Castilloux J, Noble AJ, Faure C. Risk factors for short- and long-term morbidity in children with esophageal atresia. J Pediatr. 2010 May;156(5):755-60. doi: 10.1016/j.jpeds.2009.11.038. Epub 2010 Jan 31.

  PMID: 20123142 BACKGROUND

• Serhal L, Gottrand F, Sfeir R, Guimber D, Devos P, Bonnevalle M, Storme L, Turck D, Michaud L. Anastomotic stricture after surgical repair of esophageal atresia: frequency, risk factors, and efficacy of esophageal bougie dilatations. J Pediatr Surg. 2010 Jul;45(7):1459-62. doi: 10.1016/j.jpedsurg.2009.11.002.

  PMID: 20638524 BACKGROUND

• Krishnan U, Mousa H, Dall'Oglio L, Homaira N, Rosen R, Faure C, Gottrand F. ESPGHAN-NASPGHAN Guidelines for the Evaluation and Treatment of Gastrointestinal and Nutritional Complications in Children With Esophageal Atresia-Tracheoesophageal Fistula. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):550-570. doi: 10.1097/MPG.0000000000001401.

  PMID: 27579697 BACKGROUND

MeSH Terms

Conditions

Esophageal atresia with or without tracheoesophageal fistula; Esophageal Atresia; Esophageal Stenosis

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jessica Yasuda, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Yasuda, MD

CONTACT

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

James Orozco, DO

CONTACT

james.orozco@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): June 24, 2027
• Study Completion (Estimated): June 24, 2028
• Last Updated: April 30, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)