The Australian Colonic Advanced Mucosal Neoplasia and Endoscopic Resection Study

Colonic Polyps Clinical Trial

— ACER/AMN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02000141
• Other study ID #: HREC2013/8/4.5(3778)
• Secondary ID: AU RED HREC/13/W
• Status: Active, not recruiting
• Start date: January 2014
• Est. completion date: January 2027

Study information

• Verified date: June 2023
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: January 2027
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyps

Intervention

Procedure:
• Endoscopic Mucosal Resection

Locations

Country	Name	City	State
Australia	Westmead Endoscopy Unit	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Professor Michael Bourke

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Follow up colonoscopies as per standard of care for 6 - 60 months noting and treating any recurrence.	6-60 months
Secondary	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.	Initial procedure
Secondary	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.	0-60 months