The Australian Colonic Large Sessile Lesion Endoscopic Resection Study

Colon Polyp Clinical Trial

— ACE  

Official title:

The Australian Colonic Large Sessile Lesion Endoscopic Resection Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03471793
• Other study ID #: HREC/16/WMEAD/383(4831)
• Status: Recruiting
• Start date: February 24, 2017
• Est. completion date: February 2037

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

A prospective, multicentre, observational study of all patients referred for endoscopic resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat analysis

Description:

Colonoscopic polypectomy is well established as an effective way of reducing colorectal cancer mortality. The majority of polyps detected and removed at colonoscopy are adenomas <10mm in size without advanced histology. These lesions have a low risk of progression to malignancy and are relatively easily removed by standard snare polypectomy with low complication rates. Polyps that are sessile or flat and greater than 20mm in size are found in approximately 1% of all colonoscopies and are more difficult to manage. These lesions, known as large sessile lesions (LSL), have a high rate of advanced histology. Traditionally they have been managed by referral for open or laparoscopic surgery, which is definitive, but invasive, costly and associated with a significant mortality risk in patients with advanced age or comorbidities5. Endoscopic Mucosal Resection (EMR) has emerged in recent years as an alternative to surgery that is now becoming the standard of care. It is an outpatient procedure which is effective, safe and less costly than surgery when delivered at a tertiary referral centre6.

The Australian Colonic Endoscopic Mucosal Resection study (ACE), comprises two multicentre prospective observational studies which examined EMR of colonic LSL (Ethics approval No.s HREC JH/TG 2008/9/6.1(2858) and HREC/13/WMEAD/233 (3778)). The project now has an extensive dataset from leading colonic endoscopic resection centres in Australia on more than 2000 lesions resected over 4 years since September 2008.

These studies have been successful in addressing several aspects of the resection of LSL, 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 rates, bleeding complications and mortality and costs when compared to surgery. 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 perforation, CO2 insufflation for EMR has been shown to be superior to air insufflation and succinylated gelatin (Gelofusine®) has been shown to be superior to normal saline as a submucosal lifting agent. Assessment and management strategies for bleeding and deep mural injury or perforation have been derived from analysis of the data. Snare tip soft coagulation of the resection margin post-EMR has been shown to reduce recurrence in a randomised controlled trial. Several ACE study papers have been incorporated into review papers and international guidelines for the safe and effective performance of EMR.

There remain a number of unanswered questions regarding the endoscopic resection of large sessile lesions and a new study incorporating a greater number of endoscopy units around Australia will allow these to be addressed as well as answer questions on the clinical effectiveness of the technique. Enhancing the prediction of submucosal invasive cancer, advanced lesion classification, validation of the assessment of deep injury, treatment of lesion margins post resection to reduce recurrence, prevention and prophylaxis of bleeding, and subtype analyses of the different histological groups of colonic lesions will be examined.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: February 2037
• Est. primary completion date: February 2027
• 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.

• Able to give informed consent to involvement in the clinical study

Exclusion Criteria:

• Unable to provide informed consent for involvement

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colon Polyp

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Western Sydney Local Health District

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.	6-60months
Secondary	Technical success for Endoscopic resection	To determine the safety, efficacy and predictors of success for Endoscopic Mucosal Resection of large sessile colorectal polyps.	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.	peri-procedurally