NCT03730454

Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Phoenix Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Esophageal Atresia
• Tracheoesophageal Fistula

Interventions

Type	Name	Description
DEVICE	Transanastomotic Tube (5FR)	5FR tube left in place for 5 days after completion of esophageal anastomosis.
OTHER	No Transanastomotic Tube	No transanastomotic tube used during repair

Timeline

• Start date: 2018-05-11
• Primary completion: 2025-02-28
• Completion: 2026-02-28
• First posted: 2018-11-05
• Last updated: 2025-03-10

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study