Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-11

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Esophageal Atresia Tracheoesophageal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multisite randomized control trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A. Transanastomotic Tube

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

Group Type EXPERIMENTAL

Transanastomotic Tube (5FR)

Intervention Type DEVICE

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

Group B. No Transanastomotic Tube

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

Group Type EXPERIMENTAL

No Transanastomotic Tube

Intervention Type OTHER

No transanastomotic tube used during repair

Interventions

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Transanastomotic Tube (5FR)

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

Intervention Type DEVICE

No Transanastomotic Tube

No transanastomotic tube used during repair

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No