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AzTrials

Colonic PolypsACEEMRNCT01368289

Australian Multicentre Colonic Endoscopic Mucosal Resection Study

An observational study of Colonic Polyps, run by Professor Michael Bourke at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colonic Polyps
What is being tested?
Endoscopic Mucosal Resection
Type of treatment
Surgery or procedure
How many people
3,072 participants
Where
1 siteAustralia
Study dates
Sep 2008to Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: Australian Multicentre Colonic Endoscopic Mucosal Resection (ACE/EMR) Study

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.

Read the detailed description

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
Colonic Polyps
Being tested
Endoscopic Mucosal Resection
Medical subject headings
Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Mucosal ResectionProcedure or surgery

    Endoscopic Mucosal Resection of large sessile colonic polyps.

Study groups in NCT01368289
Study groupRoleWhat they receive
Colonic PolypsPatients who present with colonic polyps >20mm
Receives: Procedure: Endoscopic Mucosal Resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6-60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2011 (estimated)
  2. Study startSep 2008
  3. Primary completionNov 2016
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,072 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01368289
Sponsor's protocol ID
ACE/EMR
Acronym
ACEEMR
Status last verified
Mar 2025
First submitted
6 Jun 2011
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40044497

  • 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.

    PubMed 39089517

  • 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.

    PubMed 38280532

  • 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.

    PubMed 37414440

  • 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.

    PubMed 37279786

  • 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.

    PubMed 36787836

  • 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.

    PubMed 35219724

  • 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.

    PubMed 33625125

  • 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.

    PubMed 31887274

  • 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.

    PubMed 28564715

  • 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.

    PubMed 27908600

  • 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.

    PubMed 27464708

  • 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.

    PubMed 27110693

  • 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.

    PubMed 27009082

  • 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.

    PubMed 26786685

Questions about this trial

What is this clinical trial studying?

An observational study of Colonic Polyps, run by Professor Michael Bourke at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical success for Endoscopic resection (time frame: 6-60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01368289, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.

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