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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03730454
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : September 24, 2021
Information provided by (Responsible Party):
Justin Lee, MD, Phoenix Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Esophageal Atresia Tracheoesophageal Fistula Device: Transanastomotic Tube (5FR) Other: No Transanastomotic Tube Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multisite randomized control trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : February 14, 2022
Estimated Study Completion Date : February 14, 2022

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

Primary Outcome Measures :
  1. Anastomotic stricture [ Time Frame: 12 months ]
    Symptomatic anastomotic stricture requiring dilation

Secondary Outcome Measures :
  1. Anastomotic Leak [ Time Frame: 12 months ]
    Anastomotic leak seen radiographically or in the operating room

  2. Recurrent Fistula [ Time Frame: 12 months ]
    Recurrent fistula seen radiographically or in the operating room

  3. Vocal cord injury [ Time Frame: 12 months ]
    vocal cord injury seen radiographically or in the operating room

  4. Unplanned return to OR [ Time Frame: 12 months ]
    Any unplanned return to opearting room

  5. Duration of perenteral nutrition [ Time Frame: 12 months ]
    Days requrining TPN

  6. Length of Stay [ Time Frame: 12 months ]
    Length of stay during hospitalization for primary repair

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03730454

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United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Justin Lee, MD    602-933-7007   
Contact: Zeb Hunteman, BS    (602) 933-1858   
United States, California
Children's Hospital Los Angeles Not yet recruiting
Los Angeles, California, United States, 90027
Contact: Lorraine Kelley-Quon, MD    323-361-1628   
Contact: Donia Hijaz    323-361-7218   
Principal Investigator: Lorriane Kelley-Quon, MD         
Rady Children's Hospital Not yet recruiting
San Diego, California, United States, 92123
Contact: David Lazar, MD    858-966-7711   
Contact: Katie Joskowitz    858-576-1700 ext 223124   
Principal Investigator: David Lazar, MD         
Sub-Investigator: Karen Kling, MD         
Benioff Children's Hospital Not yet recruiting
San Francisco, California, United States, 94158
Contact: Aaron Jensen, MD    510-428-3022   
Contact: Akbar Khan, MPH    415-476-4086   
Principal Investigator: Aaron Jensen, MD         
Lucile Packard Children's Hospital Recruiting
Stanford, California, United States, 94305
Contact: Claudia Mueller, MD, PhD    650-723-6439   
Contact: Vicente Marcelo    650-723-6439   
Principal Investigator: Claudia Mueller, MD, PhD         
Sub-Investigator: Stephen Shew, MD         
United States, Colorado
Children's Hospital Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Jose Diaz-Miron, MD    720-777-6549   
Contact: Claudia Mata, MS    720-777-0798   
Principal Investigator: Jose Diaz-Miron, MD         
United States, Oregon
Doernbecher Children's Hospital Recruiting
Portland, Oregon, United States, 97239
Contact: Elizabeth Fialkowski, MD    503-494-7764   
Contact: Andrew Mason    503-418-0104   
Principal Investigator: Elizabeth Fialkowski, MD         
Sub-Investigator: Kenneth Azarow, MD         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Katie Russell, MD    801-662-2956   
Contact: Kandace McGrath    801-581-7085   
Principal Investigator: Katie Russell, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Caitlin Smith, MD    206-987-7419   
Contact: Debra Glazer   
Principal Investigator: Caitlin Smith, MD         
Sponsors and Collaborators
Phoenix Children's Hospital
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Principal Investigator: Justin Lee, MD Phoenix Children's Hospital
  Study Documents (Full-Text)

Documents provided by Justin Lee, MD, Phoenix Children's Hospital:
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Responsible Party: Justin Lee, MD, Pediatric Surgeon, Phoenix Children's Hospital Identifier: NCT03730454    
Other Study ID Numbers: 17-136
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Esophageal Atresia
Tracheoesophageal Fistula
Pathological Conditions, Anatomical
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Congenital Abnormalities
Esophageal Fistula
Digestive System Fistula
Respiratory Tract Fistula
Respiratory Tract Diseases
Tracheal Diseases