Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

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Trial ID: NCT03730454

Age - N/A-6 Months Gender - All Accepting Healthy Volunteers - No

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


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

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Intervention(s):

device: Transanastomotic Tube (5FR)

other: No Transanastomotic Tube

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Claudia Mueller, MD, PhD
650-723-6439

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