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Colonic PolypsACER/AMNNCT02000141

The Australian Colonic Advanced Mucosal Neoplasia and Endoscopic 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

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 Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Colonic Polyps
What is being tested?
Endoscopic Mucosal Resection
Type of treatment
Surgery or procedure
How many people
1,281 participants
Where
1 siteAustralia
Study dates
Jan 2014to Jan 2027
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients referred to a study centre for colonic WF-EMR of a known sessile colonic polyp or laterally spreading tumour (LST) ≥20mm in size.

Who may be able to join

  • 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

Who cannot join

  • Unable to provide informed consent for involvement

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Westmead Endoscopy Unit

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: The Australian Colonic Advanced Mucosal Neoplasia and Endoscopic Resection Study - a Prospective Observational Cohort Study

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

Read the detailed description

The Australian Colonic Endoscopic Mucosal Resection study (ACE), is a multicentre prospective observational study which examined WF-EMR of colonic AMN (Ethics approval No. HREC JH/TG 2008/9/6.1(2858)). This project now has an extensive dataset from 8 leading colonic endoscopic resection centres in Australia on more than 1500 lesions resected over 4 years since June 2008.

The ACE study has been successful in addressing several aspects of the resection of AMN, resulting in several high profile papers in internationally recognised journals. The collection of this data has produced robust information on the efficacy of the procedure4, recurrence rates7, bleeding complications8 and mortality when compared to surgery5. Single centre analysis of the ACE dataset at Westmead has also allowed insights into how to refine the procedure to improve outcomes. The target sign is now a recognised indication for the placement of clips to prevent perforation9, CO2 insufflation for WF-EMR has been shown to be superior to air insufflation10 and succinylated gelatin (Gelofusine®) has been shown to be superior to normal saline as a submucosal lifting agent11.

There remain a number of unanswered questions regarding the endoscopic resection of large sessile lesions and expanding the ACE dataset in a new cohort of patients will allow these to be addressed. Enhancing the prediction of submucosal invasive cancer, advanced lesion classification, refinement of the assessment of deep injury, submucosal injectate constituents, the optimum electrosurgical resection methods, prevention and prophylaxis of bleeding, and subtype analyses of the different histological groups comprising AMN will be examined.

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

Study groups in NCT02000141
Study groupRoleWhat they receive
Endoscopic Mucosal ResectionEndoscopic Mucosal Resection of Colonic Advanced Mucosal Lesions
Receives: Procedure: Endoscopic Mucosal Resection

What is being measured

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

  1. Recurrence

    Follow up colonoscopies as per standard of care for 6 - 60 months noting and treating any recurrence.

    Measured: 6-60 months

Secondary outcomes (2)

  1. Cancer prediction

    By properly assessing the lesion it is hoped that we will be able to provide the greater Gastroenterology community with a tool which can be used to properly identify benign and cancerous lesions to decrease the number of benign lesions being referred to surgery.

    Measured: Initial procedure

  2. Improved Endoscopic Resection

    By assessing the lesion at resection and following up with standard of care colonoscopies it is anticipated that there will be an improved endoscopic resection efficacy therefore reducing the risk of recurrence.

    Measured: 0-60 months

Timeline

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

  1. First posted3 Dec 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2017
  4. Study completionJan 2027 (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
1,281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02000141
Sponsor's protocol ID
HREC2013/8/4.5(3778)
Other IDs
AU RED HREC/13/WMEAD/233
Acronym
ACER/AMN
Status last verified
Mar 2025
First submitted
26 Nov 2013
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
Yes

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

  • 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

  • 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.

    PubMed 32898919

  • 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.

    PubMed 28988198

  • 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.

    PubMed 28583826

  • 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

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 1 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?

Recurrence (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 NCT02000141, which also lists 10 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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