Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Esophageal Atresia, Tracheoesophageal Fistula

Intervention / Treatment
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* Device: Transanastomotic Tube (5FR)
* Other: No Transanastomotic Tube


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multisite randomized control trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A. Transanastomotic Tube<br>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)<br>* 5FR tube left in place for 5 days after completion of esophageal anastomosis.<br>|
| Experimental: Group B. No Transanastomotic Tube<br>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<br>* No transanastomotic tube used during repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic stricture | Symptomatic anastomotic stricture requiring dilation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic Leak | Anastomotic leak seen radiographically or in the operating room | 12 months | 
| Recurrent Fistula | Recurrent fistula seen radiographically or in the operating room | 12 months | 
| Vocal cord injury | vocal cord injury seen radiographically or in the operating room | 12 months | 
| Unplanned return to OR | Any unplanned return to opearting room | 12 months | 
| Duration of perenteral nutrition | Days requrining TPN | 12 months | 
| Length of Stay | Length of stay during hospitalization for primary repair | 12 months |