Australian Barrett's Cohort With Dysplasia and Early Cancer Study

Barrett's Esophagus Clinical Trial

— ABCDE  

Official title:

Australian Barrett's Cohort With Dysplasia and Early Cancer Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02198976
• Other study ID #: HREC2013/10/4.1 (3829)
• Status: Recruiting
• Start date: April 2014
• Est. completion date: April 2025

Study information

• Verified date: June 2023
• Source: Western Sydney Local Health District
• Contact: Kathleen Goodrick, BN
• Phone: 98455555
• Email: kathleen.goodrick[@]health.nsw.gov.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age less than 18
• Pregnant patients

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Locations

Country	Name	City	State
Australia	Westmead Endoscopy Unit	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Professor Michael Bourke

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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