4 Research recommendations
We have made the following recommendations for research, based on our review of evidence, to improve NICE guidance in the future.
This guideline focuses on the use of ablative and excisional therapies to treat high-grade dysplasia or intramucosal cancer in patients with Barrett's oesophagus. Therefore, the natural history of Barrett's oesophagus, including oesophageal reflux disease, diagnosis and assessment, and progression to cancer was not reviewed systematically. The Guideline Development Group noted that treatment should only be considered after a confirmed diagnosis and full assessment, and they acknowledged that research to support diagnosis and prognosis was needed. The research recommendations below focus on treatment-related questions.
What is the likelihood of Barrett's oesophagus progressing to dysplasia and cancer? What are the significant influencing factors?
Surgical treatment of high-grade dysplasia is the most effective method of treatment; however, there are significant but rare adverse effects. Ablative and excisional therapies are also successful but have an increased risk of recurrence. It is therefore important to identify patients with the highest risk of developing high-grade dysplasia, both before and after surgery, or ablative and excisional therapies. Long-term observational studies are needed to identify the risk of progression and predictive factors (for example age, sex, extent or distribution of disease, or previous treatments).
Do anatomical, pathological and molecular markers indicate successful ablation of Barrett's oesophagus and/or the risk of recurrence of high-grade dysplasia after ablative and excisional treatment?
High-grade dysplasia in Barrett's oesophagus can recur after ablative and excisional therapies; however, it is not known if there are anatomical, pathological and molecular markers associated with the success of treatment or recurrence of high-grade dysplasia. Studies to identify markers associated with long-term treatment success are needed.
What is the effectiveness of ablative and excisional therapies for the treatment of high-grade dysplasia or intramucosal cancer in Barrett's oesophagus?
Many cases were reviewed for this guideline; however, high quality evidence from randomised clinical trials on the benefit of ablative and excisional therapies was lacking. Randomised controlled trials (or well designed studies with a follow-up of at least 5 years or a central register) of ablative and excisional therapies compared with surgery, and compared with other ablative and excisional therapies are required to determine the relative benefits, costs, and impact on quality of life.
What is the most appropriate process of follow-up after the treatment of high-grade dysplasia or intramucosal cancer in Barrett's oesophagus?
Barrett's oesophagus can recur after ablative and excisional therapies. Evidence for the most appropriate follow-up is lacking so research should establish how patients should be monitored after ablative and excisional therapies. This should include randomised controlled trials (with a follow-up of at least 5 years) to evaluate the effectiveness and optimal timing of different follow-up approaches such as universal surveillance, endoscopy if symptoms recur.
What are the information needs of patients considering treatment for high-grade dysplasia or intramucosal cancer in Barrett's oesophagus?
Patients with Barrett's oesophagus deciding on the treatment of high-grade dysplasia or intramucosal cancer need information to make an informed choice. Substantial literature exists concerning their general information needs, but there is very little relating to the point of treatment choice.
Research is required into the delivery of information to patients who are considering ablative and excisional and other treatments for high-grade dysplasia in Barrett's oesophagus. This should include randomised controlled trials of different methods to support shared decision-making, with a process evaluation to identify barriers and facilitators for both patients and healthcare professionals.