About this trial
The purpose of this study is to collect prospective observational data regarding endoscopic management and outcomes of patients with Barrett's oesophagus (BO) with high grade dysplasia and/or intramucosal carcinoma. To observe the natural history of patients with low grade dysplastic and non dysplastic Barrett's oesophagus
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Can give informed consent to trial participation
Age greater than 18
Barrett's oesophagus
Disqualifiers
Age less than 18
Pregnant patients
Trial population
Patient's presenting to tertiary referral study site with HGD or IMC Barrett's Oesophagus for removal.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of Serious and Non-Serious Adverse Events
Collect prospective observational data on patients undergoing endoluminal therapy for dysplastic BO to determine * Long term risk of oesophageal adenocarcinoma (OAC) development * Long term efficacy (dysplasia and metaplasia free) in both long and short segment BO * Short and long term safety and complications * Comparison of the safety, long term efficacy, cost and patient tolerability between endoscopic mucosal resection (EMR) and radiofrequency ablation (RFA) Document the endoscopic location and characterise morphology of HGD/IMC in short and long segment BO Define the short term and long term causes of morbidity / mortality of patients undergoing ER This will be recorded on a datasheet, de-identified during the procedure.
Secondary outcomes
Number of Participants with Serious and Non-Serious Adverse Events
Establish the effect of endoluminal therapies for BO HGD/IMC on oesophageal motility. Document and grade the post EMR oesophageal defect and establish a possible link to subsequent complications (including stricture, bleeding and perforation) and recurrence. Perform cost-utility analyses comparing different treatment approaches for BO HGD/IMC, including EMR, RFA and oesophagectomy. Establish the relationship between Obstructive Sleep Apnea and BO. Understand patient attitudes and perceptions regarding BO, its treatment and its implication. Participants will be approached following their procedure and data recorded on a datasheet, this data will be linked to the initial procedure outcomes.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Professor Michael Bourke
Lead sponsor
Western Sydney Local Health District
Sponsor institution