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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02000141




Registration number
NCT02000141
Ethics application status
Date submitted
26/11/2013
Date registered
3/12/2013
Date last updated
24/07/2024

Titles & IDs
Public title
The Australian Colonic Advanced Mucosal Neoplasia and Endoscopic Resection Study
Scientific title
The Australian Colonic Advanced Mucosal Neoplasia and Endoscopic Resection Study - a Prospective Observational Cohort Study
Secondary ID [1] 0 0
AU RED HREC/13/WMEAD/233
Secondary ID [2] 0 0
HREC2013/8/4.5(3778)
Universal Trial Number (UTN)
Trial acronym
ACER/AMN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyps 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
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Endoscopic Mucosal Resection - Endoscopic Mucosal Resection of Colonic Advanced Mucosal Lesions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence
Timepoint [1] 0 0
6-60 months
Secondary outcome [1] 0 0
Cancer prediction
Timepoint [1] 0 0
Initial procedure
Secondary outcome [2] 0 0
Improved Endoscopic Resection
Timepoint [2] 0 0
0-60 months

Eligibility
Key inclusion criteria
* Patients referred for endoscopic resection of a large sessile colonic polyp or laterally spreading tumour =20mm in size.
* Age > 18 years
* Able to give informed consent to involvement in the clinical study
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to provide informed consent for involvement

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
2000
Accrual to date
Final
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
To enhance understanding of the risk factors for AMN, improve lesion assessment and prediction of submucosal invasive cancer, improve endoscopic resection efficacy, reduce complications of WF-EMR and improve the understanding of the progression of large lesions to cancer
Trial website
https://clinicaltrials.gov/study/NCT02000141
Trial related presentations / publications
Cronin O, Sidhu M, Shahidi N, Gupta S, O'Sullivan T, Whitfield A, Wang H, Kumar P, Hourigan LF, Byth K, Burgess NG, Bourke MJ. Comparison of the morphology and histopathology of large nonpedunculated colorectal polyps in the rectum and colon: implications for endoscopic treatment. Gastrointest Endosc. 2022 Jul;96(1):118-124. doi: 10.1016/j.gie.2022.02.022. Epub 2022 Feb 24.
Shaleve Y, Sabo E, Bourke MJ, Klein A. Computerized image analysis of blood vessels within mucosal defects for the prediction of delayed bleeding following colonic endoscopic mucosal resection: a pilot study. Endoscopy. 2021 Aug;53(8):837-841. doi: 10.1055/a-1258-8992. Epub 2020 Nov 10.
Bahin FF, Heitman SJ, Rasouli KN, Mahajan H, McLeod D, Lee EYT, Williams SJ, Bourke MJ. Wide-field endoscopic mucosal resection versus endoscopic submucosal dissection for laterally spreading colorectal lesions: a cost-effectiveness analysis. Gut. 2018 Nov;67(11):1965-1973. doi: 10.1136/gutjnl-2017-313823. Epub 2017 Oct 7.
Burgess NG, Hourigan LF, Zanati SA, Brown GJ, Singh R, Williams SJ, Raftopoulos SC, Ormonde D, Moss A, Byth K, Mahajan H, McLeod D, Bourke MJ. Risk Stratification for Covert Invasive Cancer Among Patients Referred for Colonic Endoscopic Mucosal Resection: A Large Multicenter Cohort. Gastroenterology. 2017 Sep;153(3):732-742.e1. doi: 10.1053/j.gastro.2017.05.047. Epub 2017 Jun 2.
Burgess NG, Bassan MS, McLeod D, Williams SJ, Byth K, Bourke MJ. Deep mural injury and perforation after colonic endoscopic mucosal resection: a new classification and analysis of risk factors. Gut. 2017 Oct;66(10):1779-1789. doi: 10.1136/gutjnl-2015-309848. Epub 2016 Jul 27.
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke, MBBS
Address 0 0
South West Sydney Area Health Service
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/study/NCT02000141