NCT03730454

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

6.8 years

First QC Date

November 1, 2018

Last Update Submit

March 5, 2025

Conditions

Esophageal AtresiaTracheoesophageal Fistula

Outcome Measures

Primary Outcomes (1)

  • Anastomotic stricture

    Symptomatic anastomotic stricture requiring dilation

    12 months

Secondary Outcomes (6)

  • Anastomotic Leak

    12 months

  • Recurrent Fistula

    12 months

  • Vocal cord injury

    12 months

  • Unplanned return to OR

    12 months

  • Duration of perenteral nutrition

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Group A. Transanastomotic Tube

EXPERIMENTAL

Group A. Transanastomotic Tube: Standard repair of EA/TEF will be performed. TT will be used during the esophageal anastomosis creation.

Device: Transanastomotic Tube (5FR)

Group B. No Transanastomotic Tube

EXPERIMENTAL

Group B. No Transanastomotic tube group: Standard repair of EA/TEF will be performed. TT will NOT be used during the esophageal anastomosis creation.

Other: No Transanastomotic Tube

Interventions

Transanastomotic Tube (5FR)DEVICE

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

Group A. Transanastomotic Tube
No Transanastomotic TubeOTHER

No transanastomotic tube used during repair

Group B. No Transanastomotic Tube

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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 may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Doernbecher Children's Hospital

Portland, Oregon, 97239, United States

Location

Children's Medical Center

Dallas, Texas, 75235, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Esophageal AtresiaTracheoesophageal Fistula

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEsophageal FistulaDigestive System FistulaRespiratory Tract FistulaRespiratory Tract DiseasesTracheal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Justin Lee, MD

    Phoenix Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multisite randomized control trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Surgeon

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 5, 2018

Study Start

May 11, 2018

Primary Completion

February 28, 2025

Study Completion

February 28, 2026

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(10)