Summary

for people ages up to 6 months (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Details

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.

Keywords

Esophageal Atresia Tracheoesophageal Fistula Fistula Transanastomotic Tube (5FR) No Transanastomotic Tube

Eligibility

You can join if…

Open to people ages up to 6 months

  • 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)

You CAN'T join if...

  • Other types of esophageal atresia without esophageal anastomosis creation
  • Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations

Locations

  • Benioff Children's Hospital not yet accepting patients
    San Francisco California 94158 United States
  • Lucile Packard Children's Hospital not yet accepting patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Phoenix Children's Hospital
ID
NCT03730454
Phase
Phase 4
Study Type
Interventional
Last Updated