Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair (TEF)
Primary Purpose
Esophageal Atresia, Tracheoesophageal Fistula
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transanastomotic Tube (5FR)
No Transanastomotic Tube
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Atresia
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
Sites / Locations
- Phoenix Children's HospitalRecruiting
- Children's Hospital Los AngelesRecruiting
- Rady Children's HospitalRecruiting
- Benioff Children's Hospital
- Lucile Packard Children's HospitalRecruiting
- Children's Hospital ColoradoRecruiting
- Doernbecher Children's HospitalRecruiting
- Children's Medical Center
- Primary Children's HospitalRecruiting
- Seattle Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A. Transanastomotic Tube
Group B. No Transanastomotic Tube
Arm Description
Group A. Transanastomotic Tube: Standard repair of EA/TEF will be performed. TT will be used during the esophageal anastomosis creation.
Group B. No Transanastomotic tube group: Standard repair of EA/TEF will be performed. TT will NOT be used during the esophageal anastomosis creation.
Outcomes
Primary Outcome Measures
Anastomotic stricture
Symptomatic anastomotic stricture requiring dilation
Secondary Outcome Measures
Anastomotic Leak
Anastomotic leak seen radiographically or in the operating room
Recurrent Fistula
Recurrent fistula seen radiographically or in the operating room
Vocal cord injury
vocal cord injury seen radiographically or in the operating room
Unplanned return to OR
Any unplanned return to opearting room
Duration of perenteral nutrition
Days requrining TPN
Length of Stay
Length of stay during hospitalization for primary repair
Full Information
NCT ID
NCT03730454
First Posted
November 1, 2018
Last Updated
February 2, 2023
Sponsor
Phoenix Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03730454
Brief Title
Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
Acronym
TEF
Official Title
A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2018 (Actual)
Primary Completion Date
February 14, 2025 (Anticipated)
Study Completion Date
February 14, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phoenix Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Atresia, Tracheoesophageal Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multisite randomized control trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A. Transanastomotic Tube
Arm Type
Experimental
Arm Description
Group A. Transanastomotic Tube: Standard repair of EA/TEF will be performed. TT will be used during the esophageal anastomosis creation.
Arm Title
Group B. No Transanastomotic Tube
Arm Type
Experimental
Arm Description
Group B. No Transanastomotic tube group: Standard repair of EA/TEF will be performed. TT will NOT be used during the esophageal anastomosis creation.
Intervention Type
Device
Intervention Name(s)
Transanastomotic Tube (5FR)
Intervention Description
5FR tube left in place for 5 days after completion of esophageal anastomosis.
Intervention Type
Other
Intervention Name(s)
No Transanastomotic Tube
Intervention Description
No transanastomotic tube used during repair
Primary Outcome Measure Information:
Title
Anastomotic stricture
Description
Symptomatic anastomotic stricture requiring dilation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Anastomotic Leak
Description
Anastomotic leak seen radiographically or in the operating room
Time Frame
12 months
Title
Recurrent Fistula
Description
Recurrent fistula seen radiographically or in the operating room
Time Frame
12 months
Title
Vocal cord injury
Description
vocal cord injury seen radiographically or in the operating room
Time Frame
12 months
Title
Unplanned return to OR
Description
Any unplanned return to opearting room
Time Frame
12 months
Title
Duration of perenteral nutrition
Description
Days requrining TPN
Time Frame
12 months
Title
Length of Stay
Description
Length of stay during hospitalization for primary repair
Time Frame
12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Lee, MD
Organizational Affiliation
Phoenix Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Lee, MD
Phone
602-933-0016
Email
jlee8@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Zeb Hunteman, BS
Phone
(602) 933-1858
Email
zhunteman@phoenixchildrens.com
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorraine Kelley-Quon, MD
Phone
323-361-1628
Email
lkquon@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Donia Hijaz
Phone
323-361-7218
Email
dhijaz@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Lorriane Kelley-Quon, MD
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Lazar, MD
Phone
858-966-7711
Email
Dlazar@rchsd.org
First Name & Middle Initial & Last Name & Degree
Katie Joskowitz
Phone
858-576-1700
Ext
223124
Email
mjoskowitz@rchsd.org
First Name & Middle Initial & Last Name & Degree
David Lazar, MD
First Name & Middle Initial & Last Name & Degree
Karen Kling, MD
Facility Name
Benioff Children's Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Jensen, MD
Phone
510-428-3022
Email
Aaron.Jensen@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Akbar Khan, MPH
Phone
415-476-4086
Email
Akbar.Khan@UCSF.edu
First Name & Middle Initial & Last Name & Degree
Aaron Jensen, MD
Facility Name
Lucile Packard Children's Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Mueller, MD, PhD
Phone
650-723-6439
Email
ClMueller@stanfordchildrens.org
First Name & Middle Initial & Last Name & Degree
Vicente Marcelo
Phone
650-723-6439
Email
vimarcelo@stanfordchildrens.org
First Name & Middle Initial & Last Name & Degree
Claudia Mueller, MD, PhD
First Name & Middle Initial & Last Name & Degree
Stephen Shew, MD
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Diaz-Miron, MD
Phone
720-777-6549
Email
jose.diaz-miron@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Claudia Mata, MS
Phone
720-777-0798
Email
claudia.mata@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Jose Diaz-Miron, MD
Facility Name
Doernbecher Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Fialkowski, MD
Phone
503-494-7764
Email
fialkows@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Andrew Mason
Phone
503-418-0104
Email
masoned@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Fialkowski, MD
First Name & Middle Initial & Last Name & Degree
Kenneth Azarow, MD
Facility Name
Children's Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Russell, MD
Phone
801-662-2956
Email
katie.russell@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Kandace McGrath
Phone
801-581-7085
Email
kandace.mcgrath@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Katie Russell, MD
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Smith, MD
Phone
206-987-7419
Email
caitlin.smith@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Debra Glazer
Email
debra.glazer@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Caitlin Smith, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
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