Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

Brief Title

Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

Official Title

A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

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.
    

Detailed Description

      Esophageal atresia 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 9 children's hospitals including Phoenix
      Children's Hospital, Doerbnercher Children's Hospital, Primary Children's Hospital, Lucille
      Packard Children's Hospital, Seattle Children's Hospital, Colorado Children's Hospital,
      Children's Hospital of Los Angeles, Rady Children's Hospital, and Benioff Children's
      Hospital. 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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Anastomotic stricture

Secondary Outcome

 Anastomotic Leak

Condition

Esophageal Atresia

Intervention

Transanastomotic Tube (5FR)

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

150

Start Date

May 11, 2018

Completion Date

May 2020

Primary Completion Date

May 2020

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - 6 Months

Accepts Healthy Volunteers

No

Contacts

Justin Lee, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03730454

Organization ID

17-136


Responsible Party

Principal Investigator

Study Sponsor

Phoenix Children's Hospital


Study Sponsor

Justin Lee, MD, Principal Investigator, Phoenix Children's Hospital


Verification Date

November 2018