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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01368289




Registration number
NCT01368289
Ethics application status
Date submitted
6/06/2011
Date registered
7/06/2011
Date last updated
24/07/2024

Titles & IDs
Public title
Australian Multicentre Colonic Endoscopic Mucosal Resection Study
Scientific title
Australian Multicentre Colonic Endoscopic Mucosal Resection (ACE/EMR) Study
Secondary ID [1] 0 0
ACE/EMR
Universal Trial Number (UTN)
Trial acronym
ACEEMR
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
Treatment: Surgery - Endoscopic Mucosal Resection

Colonic Polyps - Patients who present with colonic polyps \>20mm


Treatment: Surgery: Endoscopic Mucosal Resection
Endoscopic Mucosal Resection of large sessile colonic polyps.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Technical success for Endoscopic resection
Timepoint [1] 0 0
6-60 months

Eligibility
Key inclusion criteria
* Large sessile polyp (equal to or greater than 20mm)
* Intention to perform EMR
* Aged 18 years or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Colonic polyps less than 20mm
* Aged younger then 18 years.

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
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
Accrual to date
Final
3072
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - 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
A prospective, multicentre, observational study of all patients referred for endoscopic resection of sessile colorectal polyps sized =20 mm conducted with intention to treat analysis.
Trial website
https://clinicaltrials.gov/study/NCT01368289
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.
Shahidi N, Vosko S, Gupta S, van Hattem WA, Sidhu M, Tate DJ, Williams SJ, Lee EYT, Burgess N, Bourke MJ. Previously Attempted Large Nonpedunculated Colorectal Polyps Are Effectively Managed by Endoscopic Mucosal Resection. Am J Gastroenterol. 2021 May 1;116(5):958-966. doi: 10.14309/ajg.0000000000001096.
Tate DJ, Sidhu M, Bar-Yishay I, Desomer L, Brown G, Hourigan LF, Lee EYT, Moss A, Raftopoulos S, Singh R, Williams SJ, Zanati S, Burgess N, Bourke MJ. Impact of en bloc resection on long-term outcomes after endoscopic mucosal resection: a matched cohort study. Gastrointest Endosc. 2020 May;91(5):1155-1163.e1. doi: 10.1016/j.gie.2019.12.025. Epub 2019 Dec 28.
Tate DJ, Desomer L, Hourigan LF, Moss A, Singh R, Bourke MJ. Two-stage endoscopic mucosal resection is a safe and effective salvage therapy after a failed single-session approach. Endoscopy. 2017 Sep;49(9):888-898. doi: 10.1055/s-0043-110671. Epub 2017 May 31.
Tate DJ, Desomer L, Klein A, Brown G, Hourigan LF, Lee EY, Moss A, Ormonde D, Raftopoulos S, Singh R, Williams SJ, Zanati S, Byth K, Bourke MJ. Adenoma recurrence after piecemeal colonic EMR is predictable: the Sydney EMR recurrence tool. Gastrointest Endosc. 2017 Mar;85(3):647-656.e6. doi: 10.1016/j.gie.2016.11.027. Epub 2016 Nov 28.
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.
Bahin FF, Rasouli KN, Williams SJ, Lee EY, Bourke MJ. Prophylactic clipping for the prevention of bleeding following wide-field endoscopic mucosal resection of laterally spreading colorectal lesions: an economic modeling study. Endoscopy. 2016 Aug;48(8):754-61. doi: 10.1055/s-0042-105558. Epub 2016 Apr 25.
Tutticci N, Klein A, Sonson R, Bourke MJ. Endoscopic resection of subtotal or completely circumferential laterally spreading colonic adenomas: technique, caveats, and outcomes. Endoscopy. 2016 May;48(5):465-71. doi: 10.1055/s-0042-101854. Epub 2016 Mar 23.
Pellise M, Burgess NG, Tutticci N, Hourigan LF, Zanati SA, Brown GJ, Singh R, Williams SJ, Raftopoulos SC, Ormonde D, Moss A, Byth K, P'Ng H, Mahajan H, McLeod D, Bourke MJ. Endoscopic mucosal resection for large serrated lesions in comparison with adenomas: a prospective multicentre study of 2000 lesions. Gut. 2017 Apr;66(4):644-653. doi: 10.1136/gutjnl-2015-310249. Epub 2016 Jan 19.
Pellise M, Desomer L, Burgess NG, Williams SJ, Sonson R, McLeod D, Bourke MJ. The influence of clips on scars after EMR: clip artifact. Gastrointest Endosc. 2016 Mar;83(3):608-16. doi: 10.1016/j.gie.2015.08.071. Epub 2015 Sep 10.
Jayanna M, Burgess NG, Singh R, Hourigan LF, Brown GJ, Zanati SA, Moss A, Lim J, Sonson R, Williams SJ, Bourke MJ. Cost Analysis of Endoscopic Mucosal Resection vs Surgery for Large Laterally Spreading Colorectal Lesions. Clin Gastroenterol Hepatol. 2016 Feb;14(2):271-8.e1-2. doi: 10.1016/j.cgh.2015.08.037. Epub 2015 Sep 11.
Nanda KS, Tutticci N, Burgess NG, Sonson R, Williams SJ, Bourke MJ. Endoscopic mucosal resection of laterally spreading lesions involving the ileocecal valve: technique, risk factors for failure, and outcomes. Endoscopy. 2015 Aug;47(8):710-8. doi: 10.1055/s-0034-1391732. Epub 2015 Mar 12.
Burgess NG, Pellise M, Nanda KS, Hourigan LF, Zanati SA, Brown GJ, Singh R, Williams SJ, Raftopoulos SC, Ormonde D, Moss A, Byth K, P'Ng H, McLeod D, Bourke MJ. Clinical and endoscopic predictors of cytological dysplasia or cancer in a prospective multicentre study of large sessile serrated adenomas/polyps. Gut. 2016 Mar;65(3):437-46. doi: 10.1136/gutjnl-2014-308603. Epub 2015 Mar 2.
Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke
Address 0 0
Westmead Hospital - Endoscopy Unit
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/NCT01368289