Transanastomotic Tube for Esophageal Atresia

(TEF Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two surgical methods for infants with esophageal atresia (a blockage in the esophagus) and a tracheoesophageal fistula (a connection between the esophagus and windpipe). The goal is to determine if a transanastomotic tube (a small tube placed during surgery) can prevent the esophagus from narrowing post-surgery, which might otherwise require another procedure. Infants diagnosed with Type C esophageal atresia who need surgery within their first six months are suitable candidates for this study. As an unphased trial, it offers a unique opportunity to contribute to medical knowledge and potentially improve surgical outcomes for future patients.

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 prior data suggests that these surgical practices are safe for infants with esophageal atresia?

Research has shown that using a transanastomotic tube (TT) during esophageal atresia repair can be safe and effective, aiding early feeding after surgery. However, some risks exist. Studies have found that TTs can increase the chance of developing a postoperative stricture, a narrowing of the esophagus. Additionally, the risk of leaks at the surgical site rises with TTs; one study noted a 20% occurrence compared to 0% without their use.

While the TT facilitates early feeding, these potential complications must be considered when deciding on treatment options. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial for esophageal atresia (EA) because it explores the use of a transanastomotic tube (TT) during the surgical repair process. This tube could potentially improve outcomes by ensuring better alignment and healing of the esophagus after surgery. The trial compares two approaches: one with the TT and one without. By assessing the differences, researchers hope to determine if the TT offers superior healing and reduces complications, which could lead to a new standard in EA repair.

What evidence suggests that this trial's treatments could be effective for esophageal atresia?

This trial will compare the use of a transanastomotic tube (TT) with no tube during surgery for esophageal atresia (EA) with a tracheoesophageal fistula (TEF). Research has shown that using a TT can increase the risk of complications. Studies have found that patients with a TT are more likely to develop strictures, which are narrowings that can make swallowing difficult. One study reported a 20% chance of leaks at the surgical connection, indicating it might not heal properly. Another study found a strong link between TT use and the formation of strictures after surgery. While TT might offer some benefits, such as reducing the time a feeding tube is needed, the risks seem to outweigh these potential advantages. ^{1 2 3 6 7}

Who Is on the Research Team?

Justin Lee, MD

Principal Investigator

Phoenix Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6292097/

What is the impact of the use of transanastomotic feeding ... This study demonstrates that the use of TAFT in patients with EA significantly increases the risk of stricture.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022346824008959

Repair of Type C Tracheo-esophageal Fistula/ ... The study demonstrated that TAFT placement was associated with a higher incidence of anastomotic leaks (20% vs 0, p=0.03).

3. jpedsurg.org jpedsurg.org/article/S0022-3468(24)00895-9/abstract

Repair of Type C Tracheo-esophageal Fistula/ ... The study demonstrated that TAFT placement was associated with a higher incidence of anastomotic leaks (20 % vs 0, p = 0.03).

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022346821006254

Effect of transanastomotic feeding tubes on anastomotic ... Transanastomotic tubes are associated with a significantly higher risk of postoperative stricture following repair of esophageal atresia with tracheoesophageal ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19433166/

Use of transanastomotic feeding tubes during esophageal ... Conclusion: Transanastomotic feeding tube may lead to shorter TPN duration and decreased cholestasis, but a larger prospective study would be required to prove ...

6. withpower.com withpower.com/trial/phase-esophageal-atresia-4-2018-2e370

Transanastomotic Tube for Esophageal Atresia (TEF Trial) 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03730454

Transanastomotic Tube for Proximal Esophageal Atresia ... Primary outcome is symptomatic anastomotic stricture requiring dilation within 12 months. Official Title. A Multi-Center Randomized Trial of Transanastomotic ...