Australian Barrett's Cohort With Dysplasia and Early Cancer Study (ABCDE)

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 Overview

• Status: Recruiting
• Conditions: Barrett's Esophagus

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Kathleen Goodrick, BN; Phone Number: 59779 98455555; Email: kathleen.goodrick@health.nsw.gov.au
• Study Contact Backup: Name: Farzan F Bahin, MBBS; Phone Number: 56700 98455555; Email: farzan.fahrtash@sydney.edu.au

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Endoscopy Unit
      • Contact: Kathleen Goodrick, BN; Phone Number: 59779 98455555; Email: kathleen.goodrick@health.nsw.gov.au
      • Principal Investigator: Michael Bourke, MBBS
      • Sub-Investigator: Farzan Bahin, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient's presenting to tertiary referral study site with HGD or IMC Barrett's Oesophagus for removal.

Description

Inclusion Criteria:

• Can give informed consent to trial participation
• Age greater than 18
• Barrett's oesophagus

Exclusion Criteria:

• Age less than 18
• Pregnant patients

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Barrett's Oesophagus; 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

Collaborators and Investigators

• Sponsor: Professor Michael Bourke
• Investigators: Principal Investigator: Michael J Bourke, MBBS, Western Sydney Local Health District

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: July 17, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimated): July 24, 2014

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: HREC2013/10/4.1 (3829)