Transanastomotic Tube for Esophageal Atresia
(TEF Trial)
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.12345
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.12345
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.12456
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.12456
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.12345
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.12345
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgical Intervention
Infants undergo surgical repair of esophageal atresia with or without transanastomotic tube
Postoperative Monitoring
Participants are monitored for complications such as anastomotic stricture, leak, and vocal cord injury
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- No Transanastomotic Tube
- Transanastomotic Tube
No Transanastomotic Tube is already approved in United States for the following indications:
- Type C Esophageal Atresia Repair
- Esophageal Atresia with Distal Tracheoesophageal Fistula
Find a Clinic Near You
Who Is Running the Clinical Trial?
Phoenix Children's Hospital
Lead Sponsor