Australian Barrett's Cohort With Dysplasia and Early Cancer Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Number of Serious and Non-Serious Adverse Events
Study Overview
Brief Summary
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Can give informed consent to trial participation
- •Age greater than 18
- •Barrett's oesophagus
Exclusion Criteria
- •Age less than 18
- •Pregnant patients
Outcomes
Primary Outcomes
Number of Serious and Non-Serious Adverse Events
Time Frame: During the Barretts Excision
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(Up to 5 years after procedure)
Investigators
Professor Michael Bourke
Director of Gastrointestinal Endoscopy
Western Sydney Local Health District