Australian Barrett's Cohort With Dysplasia and Early Cancer Study

N/ARecruitingNCT02198976

Professor Michael Bourke300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Barrett's Esophagus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Can give informed consent to trial participation * Age greater than 18 * Barrett's oesophagus Exclusion Criteria: * Age less than 18 * Pregnant patients

Locations (1)

Westmead Endoscopy Unit

Westmead, New South Wales, Australia

RECRUITING

Outcomes

Primary Outcomes

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

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

Central Contacts

Michael Bourke, MBBS

CONTACT

88905555 michael@citywestgastro.com.au

Data from ClinicalTrials.gov

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