Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
Running, not enrolling · Not applicable
Conditions studied: Esophageal Atresia, Tracheoesophageal Fistula
In brief
This trial will compare the effectiveness of two common surgical practices for Type C esophageal atresia repair: esophageal atresia (EA) with distal tracheoesophageal fistula (TEF). Infants with EA/TEF requiring surgical intervention will be recruited. Subjects will be randomized to either repair with or without transanstomotic tube (TT) during esophageal anastomosis creation. Primary outcome is symptomatic anastomotic stricture development requiring dilation within 12 months.
Key facts
- Study ID
- NCT03730454
- Run by
- Phoenix Children's Hospital
- People needed
- 142
- Starts
- 2018-05-11
- Expected to finish
- 2026-02-28
- Last updated by the study team
- 2025-03-10
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants diagnosed with type C esophageal atresia: proximal esophageal atresia and distal tracheoesophageal fistula
- Primary repair of the esophageal atresia within the first six months of life
- Minimum follow up of 1 year (12 months)
You may not qualify if…
- Other types of esophageal atresia without esophageal anastomosis creation
- Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations
Where it is running
- Phoenix Children's Hospital — Phoenix, Arizona, United States
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Rady Children's Hospital — San Diego, California, United States
- Benioff Children's Hospital — San Francisco, California, United States
- Lucile Packard Children's Hospital — Stanford, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Doernbecher Children's Hospital — Portland, Oregon, United States
- Children's Medical Center — Dallas, Texas, United States
- Primary Children's Hospital — Salt Lake City, Utah, United States
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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