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The TOAST study – Treating oesophageal atresia to prevent stricture

What is it?

A “gold standard” randomised controlled trial using Omeprazole drug treatment (vs a placebo) for all OA babies.

What are the aims?

To provide solid evidence as to whether treating all OA babies with an anti-reflux drug such as Omeprazole is on balance helpful to them. A key measure, but not the only one, is the extent to which those receiving the Omeprazole experience fewer strictures or need fewer dilatations.

Why?

Despite the existence of an international guideline (ESPGHAN / NASPGHAN) suggesting Omeprazole treatment, there is no “gold standard” evidence anywhere in the world which shows this is beneficial, and some research which indicates it may well cause problems.

When?

The Feasibility study stage started in Spring 2021, and was completed during 2022. The main phase of the study is expected to be underway during Summer 2025 and run for some 6 years.

Where?

Throughout the UK. Many of the specialist NHS centres at which OA babies have surgery have agreed to be involved. The chance to take part is expected to be offered to the parents (who can decline participation) of the majority of OA babies born in the UK.

The team

The study is led by Professor Nigel Hall (Southampton University) and fellow paediatric surgeon Mr Iain Yardley (Evelina Hospital). Oxford University’s National Perinatal Epidemiology Unit is organising much of the detail of the study. The feasibility study has been undertaken by researchers at Liverpool University. Academic staff at Nottingham University are also involved. TOFS is a signatory to the collaboration agreement. The study is funded by the National Institute for Healthcare Research.

Involvement of TOFS – and TOFS members

TOFS is Patient and Public Participation partner for the study. We have been involved since 2019, and have made numerous suggestions to try to make the detail of the study (and indeed the language describing it) as patient-friendly as possible. About 20 TOFS members took part in detailed interviews as part of the feasibility study, and TOFS members make up the study’s “Parent Advisory Group”.

Impacts

Within the UK, it is very likely that surgeons will take note of the findings. In the long term, we anticipate that they will either::

  • give all OA babies Omeprazole because there will be evidence showing that on balance this can be expected to be helpful; or
  • revert to the normal situation of giving Omeprazole only in cases where there is evidence of reflux, knowing that automatic use of this drug with all babies is not generally helpful.

It is expected that the trial’s outcomes will be used to bolster the ESPGHAN / NASPGHAN recommendations – or revise them.

Publications

The feasibility study and its findings have been described in a 2023 paper in the British Medical Journal, which is accessible by anybody: “Mixed-methods feasibility study to inform a randomised controlled trial of proton pump inhibitors to reduce strictures following neonatal surgery for oesophageal atresia.” 

A presentation about TOAST has been given in 2022 to the annual congress of the British Association of Paediatric Surgeons and to the INoEA Worldwide Oesophageal Atresia conference and also to the International Clinical Trials Methodology conference.

The TOAST feasibility poster can be viewed here.

Professor Nigel Hall presented at the TOFS seminar in November 2023. Below is a video recording of his presentation.

Footnote

For a full description of the TOAST study, please see the study’s own website at Oxford University’s NPEU.  The information above is deliberately written in a patient-focussed summary form, and inevitably omits much detail.  

https://www.npeu.ox.ac.uk/toast

toast-study-logo

Updates

The latest updates to this project will be shown here as they are published.

Poster

The TOAST feasibility poster can be viewed here.