Transanastomotic Tube for Esophageal Atresia

(TEF Trial)

Recruiting at 9 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Phoenix Children's Hospital

Disqualifiers: Other EA types, Major anomaly

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

142 Participants Needed

Trial Summary

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether participants need to 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. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Transanastomotic Tube for Esophageal Atresia?

The use of transanastomotic feeding tubes (TAFT) in esophageal atresia repair is considered safe and effective, as it allows for early feeding and reduces the need for additional procedures like gastrostomy or parenteral nutrition. It does not seem to increase complications such as leaks or reflux, according to a study involving 19 patients. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

Is the transanastomotic tube safe for use in humans?

The use of transanastomotic feeding tubes (TAFT) in patients with esophageal atresia has been associated with some risks, such as esophageal strictures (narrowing of the esophagus) and gastroesophageal reflux (backflow of stomach acid into the esophagus). However, one study concluded that these tubes are generally safe and effective, reducing the need for other types of nutrition support without increasing the risk of complications like leaks or strictures. ^{1 2 4 5 6}

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. ^{1 2 3 4 5}

How does the transanastomotic tube treatment for esophageal atresia differ from other treatments?

The transanastomotic tube (TAFT) treatment for esophageal atresia is unique because it allows for early enteral nutrition (feeding directly into the stomach or intestines) without the need for a gastrostomy (a surgical opening into the stomach) or total parenteral nutrition (feeding through a vein), which can reduce costs and recovery time. ^{1 2 3 4 5}

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.

Research Team

Justin Lee, MD

Principal Investigator

Phoenix Children's Hospital

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Intervention

Infants undergo surgical repair of esophageal atresia with or without transanastomotic tube

Hospital stay

Inpatient stay for surgery

Postoperative Monitoring

Participants are monitored for complications such as anastomotic stricture, leak, and vocal cord injury

12 months

Regular follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• No Transanastomotic Tube
• Transanastomotic Tube

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Phoenix Children's Hospital

Lead Sponsor

Trials

78

Recruited

5,014,000+

Findings from Research

The use of transanastomotic feeding tubes (TAFT) in patients with esophageal atresia significantly increases the risk of developing strictures, with a risk ratio of 1.83 based on a meta-analysis of four studies involving 455 patients.

Despite the increased risk of stricture, TAFT does not appear to be associated with other major postoperative complications such as anastomotic leakage, sepsis, or pneumonia, indicating a specific safety concern rather than a broad range of risks.

NCBI (Pubmed)

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. Wang, C., Feng, L., Li, Y., et al.[2020]

In a study of 33 neonates who underwent esophageal atresia/tracheoesophageal fistula repairs, avoiding the use of transanastomotic feeding tubes (TAFT) did not lead to increased post-operative complications or longer total parenteral nutrition (TPN) duration.

Not using a TAFT was associated with a significantly lower incidence of pneumonitis, suggesting that it may reduce the risk of aspiration-related complications post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is routine use of transanastomotic tube justified in the repair of esophageal atresia? Narayanan, SK., Vazhiyodan, AP., Somnath, P., et al.[2018]

In a study of 21 children with esophageal atresia and tracheoesophageal fistula type C, the use of transanastomotic feeding tubes (TAFTs) was associated with a shorter duration of total parenteral nutrition (TPN) compared to those without feeding tubes (12 days vs 20 days).

While there were no significant differences in complications like anastomotic leaks or stenosis between the two groups, the potential benefits of TAFTs in reducing cholestasis (11% in TAFT group vs 36% in non-feeding tube group) suggest further investigation is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of transanastomotic feeding tubes during esophageal atresia repair. Alabbad, SI., Ryckman, J., Puligandla, PS., et al.[2018]

In a study of 23 patients undergoing esophageal atresia repair, the use of transanastomotic feeding tubes allowed for early enteral nutrition, significantly reducing the need for gastrostomy and parenteral nutrition during the healing period.

The approach was found to be safe and effective, with no increase in complications such as anastomotic leaks, strictures, or gastroesophageal reflux, while also lowering overall treatment costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transanastomotic feeding tubes in repair of esophageal atresia. Moriarty, KP., Jacir, NN., Harris, BH., et al.[2019]

In a review of 110 tracheoesophageal fistula repairs, the use of transanastomatic feeding tubes (TATs) was associated with a significantly higher stricture rate of 56% compared to 17% in patients without TATs, indicating a potential risk when using this intervention.

The surgical approach (thoracoscopic vs. open thoracotomy) did not affect the rates of stricture or anastomotic leak, but open thoracotomy was linked to a higher incidence of musculoskeletal complications (28% vs. 0%), suggesting that minimally invasive techniques may reduce certain postoperative risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A large single-institution review of tracheoesophageal fistulae with evaluation of the use of transanastomotic feeding tubes. Fusco, JC., Calisto, JL., Gaines, BA., et al.[2019]

In a study of 244 patients with esophageal atresia and tracheoesophageal fistula, the use of transanastomotic tubes (TATs) was linked to a significantly higher risk of developing anastomotic strictures, with a stricture rate of 36% in patients with TATs compared to 19% in those without.

Even after adjusting for various factors, patients with TATs had 2.72 times higher odds of developing strictures, indicating that TATs pose a notable risk without reducing the duration of postoperative total parenteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transanastomotic feeding tubes on anastomotic strictures in patients with esophageal atresia and tracheoesophageal fistula: The Quebec experience. LaRusso, K., Joharifard, S., Lakabi, R., et al.[2022]

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]

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

Is routine use of transanastomotic tube justified in the repair of esophageal atresia? [2018]

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

Use of transanastomotic feeding tubes during esophageal atresia repair. [2018]

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

Transanastomotic feeding tubes in repair of esophageal atresia. [2019]

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]

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]