A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

Trial Information
Status: Recruiting
Location: See all (9) 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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Maximum Age:
6 months
Healthy Volunteers:
No

• 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)

Where is this trial taking place?
United States
Arizona
Phoenix Children's Hospital
Recruiting
Phoenix
California
Children's Hospital Los Angeles
Not yet recruiting
Los Angeles
Rady Children's Hospital
Not yet recruiting
San Diego
Benioff Children's Hospital
Not yet recruiting
San Francisco
Lucile Packard Children's Hospital
Recruiting
Stanford
Colorado
Children's Hospital Colorado
Not yet recruiting
Aurora
Oregon
Doernbecher Children's Hospital
Recruiting
Portland
Utah
Primary Children's Hospital
Recruiting
Salt Lake City
Washington
Seattle Children's Hospital
Recruiting
Seattle
When is this trial taking place?
Start Date: May 11, 2018
Estimated Completion Date: February 14, 2025
How many participants will be in this trial?
Target number of participants: 136
What treatment is being studied in this trial?
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.
Who are the authors of this trial?
Lorriane Kelley-Quon, Caitlin Smith, Katie Russell, Elizabeth Fialkowski, Jose Diaz-Miron, Justin Lee, Kenneth Azarow, Karen Kling, David Lazar, Claudia Mueller, Aaron Jensen, Stephen Shew

This content was sourced from clinicaltrials.gov