TOAST - Treating Oesophageal Atresia to prevent STricture
Research type
Research Study
Full title
TOAST - A multicentre, randomised trial of gastric acid suppression medication for treating oesophageal atresia to prevent stricture
IRAS ID
1005191
Contact name
Nigel Hall
Contact email
Sponsor organisation
University of Oxford Research Governance, Ethics and Assurance
Eudract number
2022-000713-14
Research summary
Oesophageal atresia is a rare (about 1 in 2,500–3,000 births) condition where babies are born without an intact oesophagus (swallowing tube) and usually have a connection between their trachea (windpipe) and their stomach instead. It requires urgent lifesaving surgery in the first days of life. In the UK, every year around 150 babies are born with this condition
The surgery rebuilds the oesophagus, this is usually successful but sometimes there are problems. One of these problems is reflux where the acid content of the stomach comes back into the oesophagus and can cause regurgitation of feeds and/or damage to the oesophagus. Another problem that happens sometimes is that the join where the oesophagus has been rebuilt can narrow down (called a stricture) and cause difficulties with feeding and swallowing. It is thought that strictures can be caused or made worse by reflux.
Some surgeons who look after these babies use a medication to suppress the acid produced by the stomach even if there are no symptoms of reflux. A major reason for this is to reduce the risk of strictures forming. Despite this being an apparently popular option (about half of babies with oesophageal atresia are treated with this medication) the evidence for using this medication is weak. In fact, some studies of babies with oesophageal atresia have actually found that strictures are more common in babies treated with acid suppression than in those who were not. In addition, there is some suggestion that taking the medicine can increase the chance of certain types of infection.
We want to answer the question, “Should babies born with oesophageal atresia all be treated routinely with antacid medication to reduce strictures?”
In this randomised controlled trial, babies with oesophageal atresia are allocated at random to either being given acid suppressing medicine or not. They are then followed up for 2 years, to see if they develop a stricture and require any further treatments.REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0038
Date of REC Opinion
1 Dec 2023
REC opinion
Further Information Unfavourable Opinion