Colon AdenomaACENCT03471793
The Australian Colonic Large Sessile Lesion Endoscopic Resection Study
An observational study of Colon Adenoma and Colon Polyp, run by Western Sydney Local Health District at 1 site in Australia.
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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colon Adenoma, Colon Polyp
- How many people
- 5,000 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Feb 2017to Feb 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for colonic EMR of a known sessile colonic polyp or laterally spreading lesion >20mm in size
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent for involvement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Westmead Endoscopy Unit
Westmead, New South Wales, 2145
Clarence Kerrison, MBBS, 88905555, clarence.kerrison@health.nsw.gov.au
About this study
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
Read the detailed 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.
- Conditions
- Colon Adenoma, Colon Polyp
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colonic polyp | Patients referred for EMR of a colonic polyp >20mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Follow up colonoscopies as per standard of care for 6 - 60 months noting and treating any recurrence.
Measured: 6-60months
Secondary outcomes (2)
Technical success for Endoscopic resection
To determine the safety, efficacy and predictors of success for Endoscopic Mucosal Resection of large sessile colorectal polyps.
Measured: 6-60 months
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.
Measured: peri-procedurally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start24 Feb 2017
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Michael Bourke, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471793
- Sponsor's protocol ID
- HREC/16/WMEAD/383(4831)
- Acronym
- ACE
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2018
- Last updated
- 27 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Australian Colonic Large Sessile Lesion Endoscopic Resection Study
- ClinicalTrials.gov ID
- NCT03471793
- Acronym / sponsor ID
- ACE / HREC/16/WMEAD/383(4831)
- Conditions
- Colon Adenoma, Colon Polyp
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2037 (estimated)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonic polyp | – | –Patients referred for EMR of a colonic polyp >20mm |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for colonic EMR of a known sessile colonic polyp or laterally spreading lesion >20mm in size
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to provide informed consent for involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence
Time frame: 6-60months
Follow up colonoscopies as per standard of care for 6 - 60 months noting and treating any recurrence.
2 secondary outcomes
Technical success for Endoscopic resection
Time frame: 6-60 months
Cancer prediction
Time frame: peri-procedurally
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Adenoma and Colon Polyp, run by Western Sydney Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Bourke, MBBS (88905555, michael@citywestgastro.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 6-60months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.