We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

The Australian Colonic Advanced Mucosal Neoplasia and Endoscopic Resection Study (ACER/AMN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02000141
Recruitment Status : Recruiting
First Posted : December 3, 2013
Last Update Posted : November 14, 2017
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Colonic Polyps Procedure: Endoscopic Mucosal Resection

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.

Study Design

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Australian Colonic Advanced Mucosal Neoplasia and Endoscopic Resection Study - a Prospective Observational Cohort Study
Study Start Date : January 2014
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : January 2034

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Endoscopic Mucosal Resection
Endoscopic Mucosal Resection of Colonic Advanced Mucosal Lesions
Procedure: Endoscopic Mucosal Resection

Outcome Measures

Primary Outcome Measures :
  1. Recurrence [ Time Frame: 6-60 months ]
    Follow up colonoscopies as per standard of care for 6 - 60 months noting and treating any recurrence.

Secondary Outcome Measures :
  1. Cancer prediction [ Time Frame: Initial procedure ]
    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.

  2. Improved Endoscopic Resection [ Time Frame: 0-60 months ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Inclusion Criteria:

  • 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

Exclusion Criteria:

• Unable to provide informed consent for involvement

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000141

Contact: Rebecca Sonson, BN 98455555 ext 59779 bec2135@gmail.com
Contact: Michael Bourke, MBBS 98455555 ext 59779

Australia, New South Wales
Westmead Endoscopy Unit Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Rebecca Sonson, BN    98455555 ext 59779    westmeadendoscopyresearch@gmail.com   
Sub-Investigator: Nicholas Burgess, MBBS         
Principal Investigator: Michael Bourke, MBBS         
Sub-Investigator: Eric Lee, MBBS         
Sub-Investigator: Stephen Williams, MBBS         
Sponsors and Collaborators
Professor Michael Bourke
Principal Investigator: Michael Bourke, MBBS South West Sydney Area Health Service
More Information

Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT02000141     History of Changes
Other Study ID Numbers: HREC2013/8/4.5(3778)
AU RED HREC/13/WMEAD/233 ( Other Identifier: WSLHD HREC Ethics Committee )
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Pathological Conditions, Anatomical