Pneumatic balloon dilation in achalasia: a prospective comparison of balloon distention time.
A A Khan, S W Shah, A Alam...
https://pubmed.ncbi.nlm.nih.gov/9672331Actively Recruiting
Phase Not Applicable
Age: 0 - 18Years
All Genders
ID07100379
Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study
Led by Boston Children's Hospital · Updated on 2026-04-30
128
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Esophageal atresia (EA) is a common congenital condition affecting the esophagus, requiring surgical repair to survive. This research evaluates the impact of different balloon inflation times during endoscopic balloon dilation, a treatment for esophageal anastomotic strictures—a common complication after surgery that narrows the esophagus. The study aims to understand whether the duration of balloon inflation affects treatment outcomes in pediatric patients. Participants will be randomly assigned to one of two groups. Group A will receive endoscopic balloon dilation with the balloon inflated for 30 seconds, while Group B will have the balloon inflated for 180 seconds. This procedure involves placing a catheter with a balloon at the narrowed esophageal section via endoscopy and inflating it to widen the stricture. The study compares these two inflation times to assess their effects on stricture response. During the study, participants will be monitored over six months to evaluate the response of strictures to the balloon dilation and changes in the diameter of the esophageal anastomosis. Researchers will use follow-up endoscopies to measure these outcomes. The study involves regular assessments to track progress and safety, with the total participation period covering at least six months after the dilation procedure.
CONDITIONS
Brief Title
Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study
Who Can Participate
Age: 0 - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with esophageal atresia with or without tracheoesophageal fistula
- Surgically repaired esophageal atresia
- Esophageal anastomotic strictures requiring endoscopic balloon dilation
- At least one endoscopic balloon dilation for esophageal anastomotic strictures within a 6 month period
You will not qualify if you...
- Need for endoscopic incisional therapy to manage anastomotic stricture during first follow-up endoscopy
- Administration of intralesional steroid within 4 weeks of repair
- No follow-up endoscopy within 6 months
- Any anastomosis type other than esophago-esophageal (e.g. jejunal or colonic interposition)
- Failure to meet target dilation time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Within a 6 month period
Participants undergo endoscopic balloon dilation to treat esophageal strictures. The balloon will be inflated for either 30 or 180 seconds depending on their randomization group.
At least 1 endoscopic balloon dilation procedure
Follow-up
Duration - 6 months
Participants are monitored for response to the treatment and changes in esophageal diameter after the dilation procedure.
Follow-up endoscopy visits within 6 months
Trial Site Locations
Total: 2 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Loading map...
Research Team
J
Jessica Yasuda, MD
J
James Orozco, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Balloon dilation of benign esophageal rings or strictures: a randomized clinical trial comparing two different inflation times.
O Wallner, B Wallner
https://pubmed.ncbi.nlm.nih.gov/23621385An international survey on anastomotic stricture management after esophageal atresia repair: considerations and advisory statements.
Chantal A Ten Kate, Renato Tambucci, John Vlot...
https://pubmed.ncbi.nlm.nih.gov/32748272Long-term complications of congenital esophageal atresia and/or tracheoesophageal fistula.
Thomas Kovesi, Steven Rubin
https://pubmed.ncbi.nlm.nih.gov/15364774Risk factors for short- and long-term morbidity in children with esophageal atresia.
Julie Castilloux, Angela J Noble, Christophe Faure
https://pubmed.ncbi.nlm.nih.gov/20123142Anastomotic stricture after surgical repair of esophageal atresia: frequency, risk factors, and efficacy of esophageal bougie dilatations.
Lydia Serhal, Frédéric Gottrand, Rony Sfeir...
https://pubmed.ncbi.nlm.nih.gov/20638524ESPGHAN-NASPGHAN Guidelines for the Evaluation and Treatment of Gastrointestinal and Nutritional Complications in Children With Esophageal Atresia-Tracheoesophageal Fistula.
Usha Krishnan, Hayat Mousa, Luigi Dall'Oglio...
https://pubmed.ncbi.nlm.nih.gov/27579697