A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
Status: Active_not_recruiting
Location: See all (10) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: f
View:
• 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)
Locations
United States
Arizona
Phoenix Children's Hospital
Phoenix
California
Children's Hospital Los Angeles
Los Angeles
Rady Children's Hospital
San Diego
Benioff Children's Hospital
San Francisco
Lucile Packard Children's Hospital
Stanford
Colorado
Children's Hospital Colorado
Aurora
Oregon
Doernbecher Children's Hospital
Portland
Texas
Children's Medical Center
Dallas
Utah
Primary Children's Hospital
Salt Lake City
Washington
Seattle Children's Hospital
Seattle
Time Frame
Start Date: 2018-05-11
Completion Date: 2026-02-28
Participants
Target number of participants: 142
Treatments
Experimental: Group A. Transanastomotic Tube
Group A. Transanastomotic Tube: Standard repair of EA/TEF will be performed. TT will be used during the esophageal anastomosis creation.
Experimental: Group B. No Transanastomotic Tube
Group B. No Transanastomotic tube group: Standard repair of EA/TEF will be performed. TT will NOT be used during the esophageal anastomosis creation.
Authors
Related Therapeutic Areas
Sponsors
Leads: Phoenix Children's Hospital