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

Sponsor

Professor Michael Bourke (Other)

Overall Status

Recruiting

CT.gov ID

NCT02198976

Collaborator

(none)

300

Enrollment

Location

132

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Australian Barrett's Cohort With Dysplasia and Early Cancer Study

Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Barrett's Oesophagus Patients with Barrett's Oesophagus with either high grade dysplasia (HGD) or intramucosal cancer (IMC)

Outcome Measures

Primary Outcome Measures

Number of Serious and Non-Serious Adverse Events [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 Outcome Measures

Number of Participants with Serious and Non-Serious Adverse Events [Up to 5 years after procedure]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Age less than 18
Pregnant patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westmead Endoscopy Unit	Westmead	New South Wales	Australia	2145

Sponsors and Collaborators

Professor Michael Bourke

Investigators

Principal Investigator: Michael J Bourke, MBBS, Western Sydney Local Health District

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District

ClinicalTrials.gov Identifier:

NCT02198976

Other Study ID Numbers:

HREC2013/10/4.1 (3829)

First Posted:

Jul 24, 2014

Last Update Posted:

Mar 23, 2021

Last Verified:

Mar 1, 2021

Additional relevant MeSH terms:

Barrett Esophagus

Study Results

No Results Posted as of Mar 23, 2021