Australian Barrett's Cohort With Dysplasia and Early Cancer Study

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

Official Title
-----------------
Australian Barrett's Cohort With Dysplasia and Early Cancer Study

Conditions
-----------------
Barrett's Esophagus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Can give informed consent to trial participation Age greater than 18 Barrett's oesophagus Exclusion Criteria: Age less than 18 Pregnant patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Barrett's Oesophagus<br>Patients with Barrett's Oesophagus with either high grade dysplasia (HGD) or intramucosal cancer (IMC) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the Barretts Excision | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 5 years after procedure |