An interventional study of Transanastomotic Tube (5FR) and No Transanastomotic Tube in Esophageal Atresia and Tracheoesophageal Fistula, sponsored by Phoenix Children's Hospital. Active, not recruiting at 10 sites in United States. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by Phoenix Children's Hospital · Not applicable, Interventional, and Treatment
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.
Esophageal atresia is a congenital condition requiring surgical intervention. The most common configuration is Gross type C, proximal EA with distal TEF (EA/TEF). The operation for type C includes tracheoesophageal fistula closure and esophageal anastomosis creation. Although mortality has markedly decreased since the operation was first described, overall complication rate remains at 62%, with the most common complication being anastomotic stricture, 43%.
During the creation of esophageal anastomosis, two common practices are to either use or not use a transanastomtic tube (TT) across the anastomosis. However the utility and benefits of TT have not been validated. A recent retrospective analysis by the Midwestern Pediatric Surgical Research Consortium identified anastomotic stricture to be the most common postoperative complications (43%). On univariate analysis, only utilization of a TT was significantly associated with strictures (p=0.013). On multivariate analysis after adjusting for both pre and perioperative variables, TT use remained significant with an odd ratio (OR) of 1.91 (p=0.04).
Given the inherent limitations and biases of retrospective analysis, there is a critical need for a prospective multi-institutional study to validate this finding. The Western Pediatric Surgical Research Consortium (WPSRC) consists of 10 children's hospitals including Phoenix Children's Hospital, Doernbecher Children's Hospital, Primary Children's Hospital, Lucile Packard Children's Hospital, Seattle Children's Hospital, Colorado Children's Hospital, Children's Hospital of Los Angeles, Rady Children's Hospital, Benioff Children's Hospital, and Children's Medical Center Dallas. The WPSRC will conduct a prospective randomized control trial comparing the effects of TT use. Target enrollment is 150. One group of patients will receive TTs and another group of patients will not receive TTs. We hypothesize that the use of TT will result in increased anastomotic stricture formation. Primary outcome is symptomatic anastomotic stricture requiring dilation within 12 months.
37 studies on the registry are indexed under Esophageal Atresia; 12 are open to participants now.
This study's enrollment of 142 is above the median of 50 across 17 interventional studies indexed under Esophageal Atresia.
Browse Esophageal Atresia studies →Phoenix Children's Hospital is the lead sponsor of 42 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Group A. Transanastomotic Tube: Standard repair of EA/TEF will be performed. TT will be used during the esophageal anastomosis creation.
Device: Transanastomotic Tube (5FR)
Group B. No Transanastomotic tube group: Standard repair of EA/TEF will be performed. TT will NOT be used during the esophageal anastomosis creation.
Other: No Transanastomotic Tube
5FR tube left in place for 5 days after completion of esophageal anastomosis.
No transanastomotic tube used during repair
Anastomotic stricture
Symptomatic anastomotic stricture requiring dilation
Time frame: 12 months
Anastomotic Leak
Anastomotic leak seen radiographically or in the operating room
Time frame: 12 months
Recurrent Fistula
Recurrent fistula seen radiographically or in the operating room
Time frame: 12 months
Vocal cord injury
vocal cord injury seen radiographically or in the operating room
Time frame: 12 months
Unplanned return to OR
Any unplanned return to opearting room
Time frame: 12 months
Duration of perenteral nutrition
Days requrining TPN
Time frame: 12 months
Length of Stay
Length of stay during hospitalization for primary repair
Time frame: 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Feb 2025, 81 months.
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This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Phoenix Children's Hospital