Transanastomotic Tube for Esophageal Atresia

(TEF 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.

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

The trial information does not specify whether participants need to stop taking their current medications.

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.

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.

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.¹²³⁶⁷