Australian Barrett's Cohort With Dysplasia and Early Cancer Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorProfessor Michael Bourke

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Barrett's Oesophagus

Trial outcomes

Primary outcomes

1

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.

Time frame
During the Barretts Excision

Secondary outcomes

1

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.

Time frame
Up to 5 years after procedure

Other 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