Transanastomotic Tube for Esophageal Atresia

(TEF Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen by Justin Lee, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Phoenix Children's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether participants must stop taking their current medications.

What data supports the idea that Transanastomotic Tube for Esophageal Atresia is an effective treatment?

The available research shows that using a transanastomotic feeding tube (TAFT) during esophageal atresia repair can be effective. One study found that TAFTs allow for early feeding and reduce the need for other feeding methods like gastrostomy or intravenous nutrition. In a group of 19 patients, only two needed additional nutrition support, and the tubes did not seem to increase complications like leaks or reflux. This suggests that TAFTs can be a safe and cost-effective option for feeding after surgery.

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What safety data exists for transanastomotic tubes in esophageal atresia treatment?

The safety of transanastomotic tubes (TAFT) in esophageal atresia treatment is still under investigation. Some studies suggest that TAFTs may predispose patients to esophageal strictures, while others report that they are safe and effective, reducing the need for parenteral nutrition without increasing the incidence of anastomotic leaks, strictures, or gastroesophageal reflux. However, the overall safety profile remains unclear and requires further clarification.

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Is the Transanastomotic Tube a promising treatment for esophageal atresia?

The Transanastomotic Tube (TAFT) is a promising treatment for esophageal atresia because it allows for early feeding, reduces the need for more invasive procedures like gastrostomy, and is considered safe and effective. It also helps in reducing costs and does not seem to increase complications like leaks or reflux.

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Eligibility Criteria

This trial is for infants needing surgery for Type C esophageal atresia, which is a birth defect affecting the tube that connects the mouth to the stomach. Infants must be under six months old and able to have follow-ups for at least one year.

Inclusion Criteria

My infant has a specific type of esophageal birth defect.

My esophageal atresia was surgically repaired within my first six months.

Minimum follow up of 1 year (12 months)

Exclusion Criteria

I have a major health issue that could affect my treatment outcome.

My condition involves a type of esophageal atresia without surgery to connect the esophagus.

Participant Groups

The study compares two surgical methods for repairing esophageal atresia with tracheoesophageal fistula in infants: one using a transanastomotic tube during surgery, and one without it. The main focus is on whether an uncomfortable narrowing of the connection (stricture) develops within a year.

Group I: Group B. No Transanastomotic Tube Experimental Treatment 1 Intervention

Group B. No Transanastomotic tube group: Standard repair of EA/TEF will be performed. TT will NOT be used during the esophageal anastomosis creation.

Group II: Group A. Transanastomotic Tube Experimental Treatment 1 Intervention

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

No Transanastomotic Tube is already approved in United States for the following indications:

🇺🇸 Approved in United States as No Transanastomotic Tube for:

• Type C Esophageal Atresia Repair
• Esophageal Atresia with Distal Tracheoesophageal Fistula

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Benioff Children's Hospital San Francisco, CA

Children's Medical Center Dallas, TX

Lucile Packard Children's Hospital Stanford, CA

Doernbecher Children's Hospital Portland, OR

More Trial Locations

Who Is Running the Clinical Trial?

Phoenix Children's Hospital Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

What is the impact of the use of transanastomotic feeding tube on patients with esophageal atresia: a systematic review and meta-analysis. [2020] The transanastomotic feeding tube (TAFT) is widely used around the world in patients with esophageal atresia (EA). However, the safety of the use of TAFT is still unknown and remains to be clarified.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Is routine use of transanastomotic tube justified in the repair of esophageal atresia? [2018] Transanastomotic feeding tube (TAFT) is commonly used for post-operative enteral nutrition after esophageal atresia (EA)/tracheoesophageal fistula (TEF) repairs. The purpose of this study is to analyze the therapeutic implications of avoiding a TAFT and its impact on the outcomes post-operatively.

3. United States pubmed.ncbi.nlm.nih.gov

Use of transanastomotic feeding tubes during esophageal atresia repair. [2018] Esophageal atresia (EA) with tracheoesophageal fistula (TEF) type C accounts for 85% of all EA. In our center, patients were previously started on total parenteral nutrition (TPN) postoperatively and oral feedings initiated only after a contrast esophagogram. Our aim is to assess the benefit of intraoperatively placed transanastomotic feeding tubes (TAFTs).

4. United States pubmed.ncbi.nlm.nih.gov

Transanastomotic feeding tubes in repair of esophageal atresia. [2019] To avoid the need for a gastrostomy and parenteral nutrition during the 7- to 10-day healing period after esophageal anastomosis, the authors modified their technique for esophageal atresia repair to include placement of a transanastomotic feeding tube. A SILASTIC transanastomotic feeding tube and early enteral nutrition was used for 19 of 23 consecutively treated patients after repair of esophageal atresia and tracheoesophageal fistula. One of the 19 patients had recurrent fistula and another had an anastomotic leak. Five patients had significant gastroesophageal reflux (noted on barium esophagram), and four had strictures that required dilatation. Parenteral nutrition was necessary for only two patients. The authors conclude that transanastomotic feeding tubes and early enteral nutrition are safe and effective, reduce costs, and do not appear to increase the incidence of anastomotic leaks, strictures, or gastroesophageal reflux.

5. United States pubmed.ncbi.nlm.nih.gov

A large single-institution review of tracheoesophageal fistulae with evaluation of the use of transanastomotic feeding tubes. [2019] Transanastomatic feeding tube (TAT) use in the repair of tracheoesophageal fistulas (TEF) with or without esophageal atresia (EA) and EA with or without TEF allows for earlier enteral feedings, however, may predispose to esophageal stricture.

6. United States pubmed.ncbi.nlm.nih.gov

Effect of transanastomotic feeding tubes on anastomotic strictures in patients with esophageal atresia and tracheoesophageal fistula: The Quebec experience. [2022] Recent studies have identified transanastomotic tubes (TATs) as a risk factor for the development of anastomotic strictures after repair of esophageal atresia with tracheoesophageal fistula (EATEF). We further investigated these findings in a multicenter study.