1 Recommendations

1.1

More research is needed on balloon cryoablation to treat Barrett's oesophagus in adults before it can be used in the NHS.

1.2

This procedure should only be done as part of formal research and a research ethics committee needs to have approved its use.

What this means in practice

There is not enough evidence to know if this procedure is safe and effective. Balloon cryoablation to treat Barrett's oesophagus in adults should only be done as part of formal research.

Auditing of outcomes

Healthcare professionals doing this procedure should collect data on safety and outcomes of the procedure. Enter details about everyone having the procedure into the C2 CryoBalloon Ablation International Research Database Registry. Review data on outcomes and safety regularly.

Who should be involved with the procedure

Patient selection should be done by a multidisciplinary team including gastroenterologists, pathologists and surgeons. This procedure should only be done by gastroenterologists and surgeons with specific training in this procedure.

What research is needed

More research, in the form of longer-term prospective studies, is needed on:

  • patient selection, including people:

    • with different Barrett's oesophagus segment lengths

    • who have not had radiofrequency ablation

    • who cannot have radiofrequency ablation

    • whose Barrett's oesophagus is resistant to radiofrequency ablation and who are having balloon cryoablation as a secondary treatment

  • longer-term efficacy outcomes compared with radiofrequency ablation, such as:

    • time to recurrence

    • freedom from dysplasia and internal metaplasia

  • safety outcomes, including:

    • the formation, severity and longer-term impact of strictures

    • serious adverse events, such as perforation.

Studies should compare standard care (radiofrequency ablation) with balloon cryoablation done using the duration used in NHS practice, currently 8 seconds.

Why the committee made these recommendations

There is little good-quality evidence on the safety and efficacy of this procedure. All the evidence comes from observational studies. The results suggest that for some people, balloon cryoablation may cause less pain and be better tolerated or more appropriate than radiofrequency ablation. In the short term, it also appears to be as effective as radiofrequency ablation for cancer prevention and recurrence. But it has not been directly compared with radiofrequency ablation in a randomised controlled trial. Also, long-term data is lacking. So, more research is needed on long-term clinical effectiveness and safety, and for different populations.