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NCT Number: NCT02198976

Australian Barrett's Cohort With Dysplasia and Early Cancer Study

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

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

Location status: Recruiting

Location contact

Clarence Kerrison, MBBS

CONTACT

[email protected]

88905555

Farzan Bahin, MBBS

SUB_INVESTIGATOR

Michael Bourke, MBBS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age less than 18
  • Pregnant patients

Treatment and study plan

Primary outcomes

  1. Number of Serious and Non-Serious Adverse Events

    Time frame: 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 outcomes

  1. Number of Participants with Serious and Non-Serious Adverse Events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Bourke, MBBS

CONTACT

[email protected]

88905555

Sponsors and collaborators

Lead sponsor

Professor Michael Bourke

Other

Registry information

Acronym: ABCDE

Important dates

Study start
2014
Primary completion
2034
Study completion
2034
First posted
Jul 24, 2014
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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