Esophageal AtresiaTEFNCT03730454
Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
A study testing Transanastomotic Tube (5FR) and No Transanastomotic Tube in people with Esophageal Atresia and Tracheoesophageal Fistula, run by Phoenix Children's Hospital at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Esophageal Atresia, Tracheoesophageal Fistula
- What is being tested?
- Transanastomotic Tube (5FR) and No Transanastomotic Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 10 sitesUnited States
- Study dates
- 11 May 2018to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Other types of esophageal atresia without esophageal anastomosis creation
- Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Children's Medical Center
Dallas, Texas, 75235
Children's Hospital Los Angeles
Los Angeles, California, 90027
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Doernbecher Children's Hospital
Portland, Oregon, 97239
Primary Children's Hospital
Salt Lake City, Utah, 84113
Rady Children's Hospital
San Diego, California, 92123
Benioff Children's Hospital
San Francisco, California, 94158
Seattle Children's Hospital
Seattle, Washington, 98105
Lucile Packard Children's Hospital
Stanford, California, 94305
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Atresia, Tracheoesophageal Fistula
- Being tested
- Transanastomotic Tube (5FR), No Transanastomotic Tube
- Medical subject headings
- Esophageal Atresia, Tracheoesophageal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanastomotic Tube (5FR)Device
5FR tube left in place for 5 days after completion of esophageal anastomosis.
No Transanastomotic TubeOther
No transanastomotic tube used during repair
| Study group | Role | What they receive |
|---|---|---|
| Group A. Transanastomotic Tube | Experimental | Group A. Transanastomotic Tube: Standard repair of EA/TEF will be performed. TT will be used during the esophageal anastomosis creation. Receives: Device: Transanastomotic Tube (5FR) |
| Group B. No Transanastomotic Tube | Experimental | Group B. No Transanastomotic tube group: Standard repair of EA/TEF will be performed. TT will NOT be used during the esophageal anastomosis creation. Receives: Other: No Transanastomotic Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic stricture
Symptomatic anastomotic stricture requiring dilation
Measured: 12 months
Secondary outcomes (6)
Anastomotic Leak
Anastomotic leak seen radiographically or in the operating room
Measured: 12 months
Recurrent Fistula
Recurrent fistula seen radiographically or in the operating room
Measured: 12 months
Vocal cord injury
vocal cord injury seen radiographically or in the operating room
Measured: 12 months
Unplanned return to OR
Any unplanned return to opearting room
Measured: 12 months
Duration of perenteral nutrition
Days requrining TPN
Measured: 12 months
Length of Stay
Length of stay during hospitalization for primary repair
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start11 May 2018
- Primary completion28 Feb 2025
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multisite randomized control trial.
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Lee, MD, Phoenix Children's Hospital
- Investigators
- Justin Lee, MD, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730454
- Sponsor's protocol ID
- 17-136
- Acronym
- TEF
- Status last verified
- Mar 2025
- First submitted
- 1 Nov 2018
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
- ClinicalTrials.gov ID
- NCT03730454
- Acronym / sponsor ID
- TEF / 17-136
- Conditions
- Esophageal Atresia, Tracheoesophageal Fistula
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- 11 May 2018 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multisite randomized control trial.
| Arm | Type | Receives |
|---|---|---|
| Group A. Transanastomotic Tube | Experimental | Device: Transanastomotic Tube (5FR)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 | Experimental | Other: No Transanastomotic TubeGroup B. No Transanastomotic tube group: Standard repair of EA/TEF will be performed. TT will NOT be used during the esophageal anastomosis creation. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Other types of esophageal atresia without esophageal anastomosis creation
- Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transanastomotic Tube (5FR)5FR tube left in place for 5 days after completion of esophageal anastomosis. | Device | Group A. Transanastomotic Tube |
| No Transanastomotic TubeNo transanastomotic tube used during repair | Other | Group B. No Transanastomotic Tube |
Primary outcome
Anastomotic stricture
Time frame: 12 months
Symptomatic anastomotic stricture requiring dilation
6 secondary outcomes
Anastomotic Leak
Time frame: 12 months
Recurrent Fistula
Time frame: 12 months
Vocal cord injury
Time frame: 12 months
Unplanned return to OR
Time frame: 12 months
Duration of perenteral nutrition
Time frame: 12 months
Length of Stay
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Lee, MD principal investigator
Phoenix Children's Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanastomotic Tube (5FR) and No Transanastomotic Tube in people with Esophageal Atresia and Tracheoesophageal Fistula, run by Phoenix Children's Hospital at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic stricture (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.