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

NCT ID: NCT07100379

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-06-24

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A (30 seconds)

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

Group Type: EXPERIMENTAL

Endoscopic Balloon Dilation

Intervention Type: 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 B (180 seconds)

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

Group Type: EXPERIMENTAL

Endoscopic Balloon Dilation

Intervention Type: 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.

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jessica Lacy Yasuda

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Yasuda, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Central Contacts

Jessica Yasuda, MD

Role: CONTACT

Jessica.Yasuda@childrens.harvard.edu

617-355-3038

References

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.

Reference Type: BACKGROUND

PMID: 9672331 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23621385 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32748272 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15364774 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20123142 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20638524 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27579697 (View on PubMed)

Other Identifiers

IRB-P00048288

Identifier Type: -

Identifier Source: org_study_id