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RecruitingNCT03471793ACEUpdated Mar 27, 2025

The Australian Colonic Large Sessile Lesion Endoscopic Resection Study

An observational study in Colon Adenoma and Colon Polyp, sponsored by Western Sydney Local Health District. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Western Sydney Local Health District · Observational

From the registry’s dates

  • Started Feb 2017; still recruiting 9 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years to 99 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Colon Adenoma
  • Colon Polyp

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03

In context

Colonic Polyps

377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 411 across 115 observational studies indexed under Colonic Polyps.

Browse Colonic Polyps studies →

Lead sponsor

Western Sydney Local Health District is the lead sponsor of 36 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients referred for colonic EMR of a known sessile colonic polyp or laterally spreading lesion >20mm in size

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients referred for endoscopic resection of a large sessile colonic polyp or laterally spreading tumour ≥20mm in size.
  • Able to give to involvement in the clinical study

Exclusion criteria

Exclusion Criteria:

  • Unable to provide for involvement
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Colonic polyp

    Patients referred for EMR of a colonic polyp \>20mm

06

What researchers measure

Primary outcomes

  1. Recurrence

    Follow up colonoscopies as per standard of care for 6 - 60 months noting and treating any recurrence.

    Time frame: 6-60months

Secondary outcomes

  1. Technical success for Endoscopic resection

    To determine the safety, efficacy and predictors of success for Endoscopic Mucosal Resection of large sessile colorectal polyps.

    Time frame: 6-60 months

  2. 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.

    Time frame: peri-procedurally

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2017 (actual). Primary completion is estimated for Feb 2027, 120 months after the start.

Of 52 non-industry observational studies under Colonic Polyps, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 90. This study's planned 120 months is above that.

Counting every sponsor, half of 62 studies reached it within 19 months; a quarter within 10 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2018
First posted
Mar 21, 2018
StartActual
Feb 24, 2017
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2037
Last update
Mar 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03471793
Lead sponsor
Western Sydney Local Health District
Responsible party
Professor Michael Bourke (Director of Interventional Endoscopy, Western Sydney Local Health District) — Principal investigator
First posted
Mar 21, 2018
Start date
Feb 24, 2017
Primary completion
Feb 2027 (estimated)
Completion
Feb 2037 (estimated)
Last update
Mar 27, 2025

Study contacts

Michael Bourke, MBBS
Contact
michael@citywestgastro.com.au
88905555

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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