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Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

NCT03730454 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-03-10

No results posted yet for this study

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.

Conditions

  • Esophageal Atresia
  • Tracheoesophageal Fistula

Interventions

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

Sponsors & Collaborators

  • Phoenix Children's Hospital

    lead OTHER

Principal Investigators

  • Justin Lee, MD · Phoenix Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-11
Primary Completion
2025-02-28
Completion
2026-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03730454 on ClinicalTrials.gov