Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02200250




Registration number
NCT02200250
Ethics application status
Date submitted
17/07/2014
Date registered
25/07/2014
Date last updated
3/07/2023

Titles & IDs
Public title
Long Term Barrett's Endoscopic Mucosal Resection Study
Scientific title
Long Term Outcomes of Patients Undergoing Endoscopic Resection of Barrett's Oesophagus (BO) With High Grade Dysplasia (HGD) and Early Adenocarcinoma
Secondary ID [1] 0 0
HREC2013/10/6.2(3838)QA
Universal Trial Number (UTN)
Trial acronym
CBE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Barretts Esophagus 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Post Barretts Excision - Patients who have undergone an EMR for Barretts Oesophagus
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reviewing patients symptoms following resection
Timepoint [1] 0 0
up to 3 years

Eligibility
Key inclusion criteria
- 18 years or over

- Have or have had Barrett's Oesophagus
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Do not have Barrett's Oesophagus

- Have not had Barrett's Oesophagus resected at Westmead Hospital

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2022
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Analysis of long term outcomes of patients undergoing endoscopic mucosal resection for
Barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (IMC).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02200250
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Bourke, MBBS
Address 0 0
Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02200250