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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Western Sydney Local Health District
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District
ClinicalTrials.gov Identifier:
NCT02000141
First received: November 26, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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 Intervention
Colonic Polyps
Procedure: Endoscopic Mucosal Resection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Australian Colonic Advanced Mucosal Neoplasia and Endoscopic Resection Study - a Prospective Observational Cohort Study

Resource links provided by NLM:


Further study details as provided by Western Sydney Local Health District:

Primary Outcome Measures:
  • Recurrence [ Time Frame: 6-60 months ] [ Designated as safety issue: No ]
    Follow up colonoscopies as per standard of care for 6 - 60 months noting and treating any recurrence.


Secondary Outcome Measures:
  • Cancer prediction [ Time Frame: Initial procedure ] [ Designated as safety issue: No ]
    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.

  • Improved Endoscopic Resection [ Time Frame: 0-60 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2000
Study Start Date: January 2014
Estimated Study Completion Date: January 2034
Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Endoscopic Mucosal Resection
Endoscopic Mucosal Resection of Colonic Advanced Mucosal Lesions
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000141

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

Locations
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
Investigators
Principal Investigator: Michael Bourke, MBBS South West Sydney Area Health Service
  More Information

No publications provided

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
Study First Received: November 26, 2013
Last Updated: June 30, 2014
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on August 26, 2014