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Esophageal Atresia With Tracheo-esophageal FistulaBITESNCT07100379

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

A study testing Endoscopic Balloon Dilation in people with Esophageal Atresia With Tracheo-esophageal Fistula and Esophageal Atresia, run by Boston Children's Hospital at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years
What is being tested?
Endoscopic Balloon Dilation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
2 sitesUnited States
Study dates
28 Oct 2025to 24 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jessica Yasuda, MD contact

617-355-3038

Jessica.Yasuda@childrens.harvard.edu

James Orozco, DO contact

james.orozco@childrens.harvard.edu

United States2 sites, 2 recruiting

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

    Jessica Yasuda, MD, jessica.yasuda@childrens.harvard.edu

    James Orozco, DO, james.orozco@childrens.harvard.edu

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Michael Manfredi, MD, manfredim@chop.edu

    Rosa Hwang, HWANGR3@chop.edu

    Recruiting

Other trials in United States

About this 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.

Being tested
Endoscopic Balloon Dilation
Keywords
endoscopic balloon dilation, post-surgical correction, esophageal strictures
Medical subject headings
Esophageal atresia with or without tracheoesophageal fistula, Esophageal Atresia, Esophageal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Balloon DilationProcedure or surgery

    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.

Study groups in NCT07100379
Study groupRoleWhat they receive
Group A (30 seconds)ExperimentalPatients who are randomized into Group A will undergo endoscopic balloon dilation for a total of 30 seconds.
Receives: Procedure: Endoscopic Balloon Dilation
Group B (180 seconds)ExperimentalPatients randomized into Group B will undergo endoscopic balloon dilation for a duration of 180 seconds.
Receives: Procedure: Endoscopic Balloon Dilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (1)

  1. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2025
  2. Study start28 Oct 2025
  3. Primary completion24 Jun 2027 (estimated)
  4. Study completion24 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07100379
Sponsor's protocol ID
IRB-P00048288
Acronym
BITES
Status last verified
Jul 2025
First submitted
28 Jul 2025
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 9672331

  • 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.

    PubMed 23621385

  • 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.

    PubMed 32748272

  • 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.

    PubMed 15364774

  • 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.

    PubMed 20123142

  • 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.

    PubMed 20638524

  • 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.

    PubMed 27579697

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic Balloon Dilation in people with Esophageal Atresia With Tracheo-esophageal Fistula and Esophageal Atresia, run by Boston Children's Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jessica Yasuda, MD (617-355-3038, Jessica.Yasuda@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stricture response to endoscopic balloon dilation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07100379, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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