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The oesophagus is a muscular tube connecting the mouth and stomach. In Barrett's oesophagus, the cells lining the lower part of the oesophagus change, becoming more like the cells lining the intestines (intestinal metaplasia). The changed cells can become abnormal (dysplastic) over time. There is a small chance of the abnormal cells becoming cancerous. Treatment may be offered to try and remove the affected tissue. This aims to lower the cancer risk.
Management of Barrett's oesophagus may include lifestyle changes, acid-suppressing medicines, endoscopic mucosal resection, endoscopic submucosal dissection, ablative therapies and surgery. Ablative therapies include radiofrequency ablation, photodynamic therapy, argon plasma coagulation, laser ablation, multipolar electrocoagulation and cryotherapy. People with Barrett's oesophagus whose cells are dysplastic may be offered ablative therapy, but which one depends on the grading of the dysplasia.
NICE's guideline on the monitoring and management of Barrett's oesophagus and stage 1 oesophageal adenocarcinoma recommends offering radiofrequency ablation to people with low-grade dysplasia confirmed by 2 separate endoscopies. Endoscopic resection of visible lesions should be offered as first-line treatment to people with high-grade dysplasia. Endoscopic ablation may be offered after the initial resection to treat any residual Barrett's oesophagus.
Treatment options for Barrett's oesophagus may not always be feasible or suitable. Radiofrequency ablation should be avoided in people with severe comorbidities (such as cardiopulmonary disease) or in people unable to stop anticoagulation therapy. It may also be unfeasible because of an uneven Barrett's oesophagus surface or because of oesophageal strictures precluding passage of the radiofrequency ablation catheter. Endoscopic resection may be unsuitable for people with coagulation disorders, portal hypertension and people unable to stop anticoagulation therapy. It may also be difficult for longer Barrett's oesophagus segments or if there is no endoscopically visible lesion.
Cryoablation may be an option for some people who cannot have radiofrequency ablation. It may cause less pain than radiofrequency ablation in some people. In addition, it may be better tolerated or more appropriate than radiofrequency ablation or endoscopic resection for some people with comorbidities.
The cryoballoon is configured in both cylindrical and pear shapes, as well as different sizes, to allow for more tailored treatment. The pear-shaped balloon may be preferred for people with narrowing at the distal oesophagus or gastroesophageal junction. It may also be used when there is difficulty in stabilising the position of the cylinder because of a pre-existing or new stenosis.
NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 9 sources, which was discussed by the committee. The evidence included 1 meta-analysis and 8 observational studies (4 prospective cohort and 4 retrospective analyses). It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
The professional experts and the committee considered the key safety outcomes to be pain, stricture formation and perforation.
Five commentaries from people who have had this procedure were received. The views of these people were mostly positive, with some negative views about sedation noted.
Patient pathways and indications for cryoablation use are not clear. Prospective studies have focused on groups with an unmet need, such as people who are resistant to radiofrequency ablation. More evidence is needed clearly identifying the patient pathway and across wider population groups to address uncertainties about who would most benefit from the procedure.
In the UK, the procedure is currently only done for people with short Barrett's oesophagus segment lengths. When length was reported, the evidence base was limited to lengths of 6 cm or less. The safety and efficacy of the procedure for longer segment lengths is not clear from the evidence.
There may be a role for cryoablation for people who are resistant to radiofrequency ablation. But most of the identified evidence only included people who had not had this treatment. So, evidence for cryoablation as a secondary treatment is limited, and more evidence is needed on the safety and efficacy of this use.
While most short-term safety data seems reassuring, longer-term issues with strictures need further exploration. A comparative study with standard care (radiofrequency ablation) would be useful.
Current research includes only a small sample of people. Longer-term outcome data on balloon cryoablation in more people would be beneficial, looking at:
how many people remain free from dysplasia and metaplasia
the length of time before any recurrence.
Ideally, this would be in the context of a comparison with standard care (radiofrequency ablation) in a randomised control trial.
The committee was pleased that a UK registry evaluating the Focal C2 CryoBalloon Ablation System for Barrett's oesophagus-related neoplasia has been established. But data on only a small cohort of people with Barrett's oesophagus has been included to date. Also, results from the registry have not yet been published in a full-text peer-reviewed journal article. Recruitment of more people to the cohort would be useful, and publication of outcomes in peer-reviewed journals could be used to inform future decisions.
The committee are aware of different cryoablation durations being used from the included research. Research on outcomes using the same cryoablation duration as that employed within the UK would be useful.
The prevalence of Barrett's oesophagus is related to age, typically affecting adults over 50.
Barrett's oesophagus is between 2 to 4 times more common among men than women, across all ages.
Barretts oesophagus is more common among those from White backgrounds.
The committee noted that there are only certain centres in the UK that offer balloon cryoablation ablation. So, people living further from these centres may not have access to this procedure.
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