Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair (TEF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Atresia; Tracheoesophageal Fistula
• Intervention / Treatment: Device: Transanastomotic Tube (5FR); Other: No Transanastomotic Tube

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Phoenix Children's Hospital
      • Contact: Justin Lee, MD; Phone Number: 602-933-0016; Email: jlee8@phoenixchildrens.com
      • Contact: Zeb Hunteman, BS; Phone Number: (602) 933-1858; Email: zhunteman@phoenixchildrens.com
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital Los Angeles
      • Contact: Lorraine Kelley-Quon, MD; Phone Number: 323-361-1628; Email: lkquon@chla.usc.edu
      • Principal Investigator: Lorriane Kelley-Quon, MD
      • Contact: Nikhita Datar; Phone Number: 323-361-7218; Email: ndatar@chla.usc.edu
    • San Diego, California, United States, 92123
      • Recruiting
      • Rady Children's Hospital
      • Principal Investigator: David Lazar, MD
      • Contact: David Lazar, MD; Phone Number: 858-966-7711; Email: Dlazar@rchsd.org
      • Contact: Katie Joskowitz; Phone Number: 223124 858-576-1700; Email: mjoskowitz@rchsd.org
      • Sub-Investigator: Karen Kling, MD
    • San Francisco, California, United States, 94158
      • Not yet recruiting
      • Benioff Children's Hospital
      • Contact: Aaron Jensen, MD; Phone Number: 510-428-3022; Email: Aaron.Jensen@ucsf.edu
      • Contact: Dane Munar; Phone Number: 415-476-6978; Email: Dane.Munar@ucsf.edu
      • Principal Investigator: Aaron Jensen, MD
    • Stanford, California, United States, 94305
      • Recruiting
      • Lucile Packard Children's Hospital
      • Contact: Claudia Mueller, MD, PhD; Phone Number: 650-723-6439; Email: ClMueller@stanfordchildrens.org
      • Principal Investigator: Claudia Mueller, MD, PhD
      • Contact: Elena Harnish; Phone Number: 650-723-6439; Email: eharnish@stanford.edu
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Jose Diaz-Miron, MD; Phone Number: 720-777-6549; Email: jose.diaz-miron@childrenscolorado.org
      • Contact: Claudia Mata, MS; Phone Number: 720-777-0798; Email: claudia.mata@childrenscolorado.org
      • Principal Investigator: Jose Diaz-Miron, MD
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Doernbecher Children's Hospital
      • Contact: Elizabeth Fialkowski, MD; Phone Number: 503-494-7764; Email: fialkows@ohsu.edu
      • Contact: Andrew Mason; Phone Number: 503-418-0104; Email: masoned@ohsu.edu
      • Principal Investigator: Elizabeth Fialkowski, MD
      • Sub-Investigator: Kenneth Azarow, MD
  • Texas
    • Dallas, Texas, United States, 75235
      • Active, not recruiting
      • Children's Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Recruiting
      • Primary Children's Hospital
      • Contact: Katie Russell, MD; Phone Number: 801-662-2956; Email: katie.russell@hsc.utah.edu
      • Contact: Kezlyn Larsen; Phone Number: 801-662-2989; Email: kezlyn.larsen@hsc.utah.edu
      • Principal Investigator: Katie Russell, MD
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Contact: Caitlin Smith, MD; Phone Number: 206-987-7419; Email: caitlin.smith@seattlechildrens.org
      • Contact: Debra Glazer; Email: debra.glazer@seattlechildrens.org
      • Principal Investigator: Caitlin Smith, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Transanastomotic Tube (5FR); 5FR tube left in place for 5 days after completion of esophageal anastomosis.
Experimental: 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.	Other: No Transanastomotic Tube; No transanastomotic tube used during repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic stricture	Symptomatic anastomotic stricture requiring dilation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic Leak	Anastomotic leak seen radiographically or in the operating room	12 months
Recurrent Fistula	Recurrent fistula seen radiographically or in the operating room	12 months
Vocal cord injury	vocal cord injury seen radiographically or in the operating room	12 months
Unplanned return to OR	Any unplanned return to opearting room	12 months
Duration of perenteral nutrition	Days requrining TPN	12 months
Length of Stay	Length of stay during hospitalization for primary repair	12 months

Collaborators and Investigators

• Sponsor: Phoenix Children's Hospital
• Investigators: Principal Investigator: Justin Lee, MD, Phoenix Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2018
• Primary Completion (Estimated): February 14, 2025
• Study Completion (Estimated): February 14, 2025

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Digestive System Fistula; Digestive System Abnormalities; Tracheal Diseases; Esophageal Fistula; Respiratory Tract Fistula; Fistula; Esophageal Atresia; Tracheoesophageal Fistula
• Other Study ID Numbers: 17-136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes