Australian Multicentre Colonic Endoscopic Mucosal Resection Study

NCT01368289 | Active Not Recruiting

• 1 other identifier: ACE/EMR
• Study Type: observational
• Target: 3,072
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (1)

• Technical success for Endoscopic resection

  To determine the safety, efficacy and predictors of success for Endoscopic Mucosal Resection of large sessile colorectal polyps. The utility of endoscopic criteria to stratify for the risk of Submucosal Invasive Cancer was also assessed.

  6-60 months

Study Arms (1)

Colonic Polyps

Patients who present with colonic polyps \>20mm

Procedure: Endoscopic Mucosal Resection

Interventions

Endoscopic Mucosal Resection PROCEDURE

Endoscopic Mucosal Resection of large sessile colonic polyps.

Colonic Polyps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patient who presents to the Unit with the intention to treat large sessile colonic polyps equal to or greater than 20mm.

You may qualify if:

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

You may not qualify if:

• Colonic polyps less than 20mm
• Aged younger then 18 years.

Sponsors & Collaborators

• Professor Michael Bourke: lead

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Related Publications (20)

• 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.

  PMID: 40044497 DERIVED

• 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.

  PMID: 39089517 DERIVED

• 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.

  PMID: 38280532 DERIVED

• 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.

  PMID: 37414440 DERIVED

• 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.

  PMID: 37279786 DERIVED

• 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.

  PMID: 36787836 DERIVED

• 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.

  PMID: 35219724 DERIVED

• 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.

  PMID: 33625125 DERIVED

• 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.

  PMID: 31887274 DERIVED

• 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.

  PMID: 28564715 DERIVED

• 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.

  PMID: 27908600 DERIVED

• 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.

  PMID: 27464708 DERIVED

• 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.

  PMID: 27110693 DERIVED

• 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.

  PMID: 27009082 DERIVED

• 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.

  PMID: 26786685 DERIVED

• 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.

  PMID: 26364966 DERIVED

• 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.

  PMID: 26364679 DERIVED

• 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.

  PMID: 25763831 DERIVED

• 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.

  PMID: 25731869 DERIVED

• 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.

  PMID: 24986245 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Michael Bourke

  Westmead Hospital - Endoscopy Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Michael Bourke

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 7, 2011
• Study Start: September 1, 2008
• Primary Completion: November 1, 2016
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

AU (1)