Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

Esophageal atresia 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 9 children's hospitals including Phoenix
Children's Hospital, Doerbnercher Children's Hospital, Primary Children's Hospital, Lucille
Packard Children's Hospital, Seattle Children's Hospital, Colorado Children's Hospital,
Children's Hospital of Los Angeles, Rady Children's Hospital, and Benioff Children's
Hospital. 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.

Inclusion Criteria:

- 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)

Exclusion Criteria:

- Other types of esophageal atresia without esophageal anastomosis creation

- Major anomaly that influences likelihood of developing primary outcome or affects
surgical treatment considerations