Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03730454

Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transanastomotic Tube (5FR)

Device

5FR tube left in place for 5 days after completion of esophageal anastomosis.

No Transanastomotic Tube

Other

No transanastomotic tube used during repair

Primary outcomes

  1. Anastomotic stricture

    Time frame: 12 months

    Symptomatic anastomotic stricture requiring dilation

Secondary outcomes

  1. Anastomotic Leak

    Time frame: 12 months

    Anastomotic leak seen radiographically or in the operating room

  2. Recurrent Fistula

    Time frame: 12 months

    Recurrent fistula seen radiographically or in the operating room

  3. Vocal cord injury

    Time frame: 12 months

    vocal cord injury seen radiographically or in the operating room

  4. Unplanned return to OR

    Time frame: 12 months

    Any unplanned return to opearting room

  5. Duration of perenteral nutrition

    Time frame: 12 months

    Days requrining TPN

  6. Length of Stay

    Time frame: 12 months

    Length of stay during hospitalization for primary repair

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Registry information

Official study title

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

Acronym: TEF

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Nov 5, 2018
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.