Australian Multicentre Colonic Endoscopic Mucosal Resection Study

NCT ID: NCT01368289

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3072 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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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. Detailed data regarding lesion characteristics (size, location, Paris classification, granular or non-granular surface morphology and Kudo pit pattern), procedural, clinical and histological outcomes and complications are noted. Multivariate analysis will be performed to identify risk factors for Endoscopic Mucosal Resection failure and adenoma recurrence at follow-up colonoscopy.

Conditions

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Colonic Polyps

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Colonic Polyps

Patients who present with colonic polyps \>20mm

Endoscopic Mucosal Resection

Intervention Type PROCEDURE

Endoscopic Mucosal Resection of large sessile colonic polyps.

Interventions

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Endoscopic Mucosal Resection

Endoscopic Mucosal Resection of large sessile colonic polyps.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Large sessile polyp (equal to or greater than 20mm)
* Intention to perform EMR
* Aged 18 years or older

Exclusion Criteria

* Colonic polyps less than 20mm
* Aged younger then 18 years.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Professor Michael Bourke

OTHER

Sponsor Role lead

Responsible Party

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Professor Michael Bourke

Dr Michael Bourke

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael Bourke

Role: PRINCIPAL_INVESTIGATOR

Westmead Hospital - Endoscopy Unit

Locations

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Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Countries

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Australia

References

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Gauci JL, Mandarino FV, Kerrison C, Whitfield AM, O'Sullivan T, Gupta S, Lam B, Perananthan V, Cronin O, Lee EY, Williams SJ, Burgess N, Bourke MJ. Margin thermal ablation eliminates size as a risk factor for recurrence after piecemeal endoscopic mucosal resection of large non-pedunculated colorectal polyps. Gut. 2025 Apr 7;74(5):752-760. doi: 10.1136/gutjnl-2024-333563.

Reference Type DERIVED
PMID: 40044497 (View on PubMed)

Gauci JL, Whitfield A, Medas R, Kerrison C, Mandarino FV, Gibson D, O'Sullivan T, Cronin O, Gupta S, Lam B, Perananthan V, Hourigan L, Zanati S, Singh R, Raftopoulos S, Moss A, Brown G, Klein A, Desomer L, Tate DJ, Williams SJ, Lee EY, Burgess N, Bourke MJ. Prevalence of Endoscopically Curable Low-Risk Cancer Among Large (>/=20 mm) Nonpedunculated Polyps in the Right Colon. Clin Gastroenterol Hepatol. 2025 Mar;23(4):555-563.e1. doi: 10.1016/j.cgh.2024.07.017. Epub 2024 Jul 31.

Reference Type DERIVED
PMID: 39089517 (View on PubMed)

Tate DJ, Vosko S, Bar-Yishay I, Desomer L, Shahidi N, Sidhu M, McLeod D, Bourke MJ. Incomplete mucosal layer excision during EMR: a potential source of recurrent adenoma (with video). Gastrointest Endosc. 2024 Sep;100(3):501-509. doi: 10.1016/j.gie.2024.01.030. Epub 2024 Jan 25.

Reference Type DERIVED
PMID: 38280532 (View on PubMed)

Tate DJ, Desomer L, Argenziano ME, Mahajan N, Sidhu M, Vosko S, Shahidi N, Lee E, Williams SJ, Burgess NG, Bourke MJ. Treatment of adenoma recurrence after endoscopic mucosal resection. Gut. 2023 Oct;72(10):1875-1886. doi: 10.1136/gutjnl-2023-330300. Epub 2023 Jul 6.

Reference Type DERIVED
PMID: 37414440 (View on PubMed)

Gupta S, Vosko S, Shahidi N, O'Sullivan T, Cronin O, Whitfield A, Kurup R, Sidhu M, Lee EYT, Williams SJ, Burgess NG, Bourke MJ. Endoscopic resection-related colorectal strictures: risk factors, management, and long-term outcomes. Endoscopy. 2023 Nov;55(11):1010-1018. doi: 10.1055/a-2106-6494. Epub 2023 Jun 6.

Reference Type DERIVED
PMID: 37279786 (View on PubMed)

O'Sullivan T, Tate D, Sidhu M, Gupta S, Elhindi J, Byth K, Cronin O, Whitfield A, Craciun A, Singh R, Brown G, Raftopoulos S, Hourigan L, Moss A, Klein A, Heitman S, Williams S, Lee E, Burgess NG, Bourke MJ. The Surface Morphology of Large Nonpedunculated Colonic Polyps Predicts Synchronous Large Lesions. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2270-2277.e1. doi: 10.1016/j.cgh.2023.01.034. Epub 2023 Feb 12.

Reference Type DERIVED
PMID: 36787836 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35219724 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33625125 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31887274 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28564715 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27908600 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27464708 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27110693 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27009082 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26786685 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26364966 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26364679 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25763831 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25731869 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24986245 (View on PubMed)

Other Identifiers

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ACE/EMR

Identifier Type: -

Identifier Source: org_study_id

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