NCT02000141

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,281

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2014Jan 2027

First Submitted

Initial submission to the registry

November 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

November 26, 2013

Last Update Submit

March 25, 2025

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (1)

  • Recurrence

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

    6-60 months

Secondary Outcomes (2)

  • Cancer prediction

    Initial procedure

  • Improved Endoscopic Resection

    0-60 months

Study Arms (1)

Endoscopic Mucosal Resection

Endoscopic Mucosal Resection of Colonic Advanced Mucosal Lesions

Procedure: Endoscopic Mucosal Resection

Interventions

Endoscopic Mucosal ResectionPROCEDURE
Endoscopic Mucosal Resection

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Unable to provide informed consent for involvement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

Location

Related Publications (10)

  • 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: 40044497DERIVED

  • 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: 39089517DERIVED

  • 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: 38280532DERIVED

  • 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: 37414440DERIVED

  • 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: 36787836DERIVED

  • 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: 35219724DERIVED

  • 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.

    PMID: 32898919DERIVED

  • 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.

    PMID: 28988198DERIVED

  • 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.

    PMID: 28583826DERIVED

  • 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: 27464708DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Michael Bourke, MBBS

    South West Sydney Area Health Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Gastrointestinal Endoscopy

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 3, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2017

Study Completion (Estimated)

January 1, 2027

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

AU(1)