Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

Trial ID or NCT#

NCT03730454

Status

recruiting iconRECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: Younger than 6 Months
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - Other types of esophageal atresia without esophageal anastomosis creation - Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations
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Contact us to find out if this trial is right for you.

Contact

Claudia Mueller, MD, PhD
650-723-6439

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View on ClinicalTrials.gov