Observational study on endoscopic resection of large sessile colorectal polyps
The Australian Colonic Large Sessile Lesion Endoscopic Resection Study
This study is testing if a procedure called Endoscopic Mucosal Resection (EMR) is a safe and effective way to remove large colorectal polyps for patients who need treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Western Sydney Local Health District Academic / other |
| Locations | 1 site (Westmead, New South Wales) |
| Trial ID | NCT03471793 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, multicentre observational analysis focusing on patients referred for the endoscopic resection of sessile colorectal polyps that are 20 mm or larger. It aims to evaluate the effectiveness and safety of Endoscopic Mucosal Resection (EMR) as an alternative to traditional surgical methods for managing these challenging lesions. By collecting data from leading endoscopic resection centers in Australia, the study seeks to enhance understanding of the outcomes associated with EMR in treating large sessile lesions. The intention-to-treat analysis will provide insights into the management of these polyps and their histological characteristics.
Who should consider this trial
Good fit: Ideal candidates for this study are patients referred for endoscopic resection of large sessile colonic polyps or laterally spreading tumors that are 20 mm or larger.
Not a fit: Patients who are unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and safer treatment option for patients with large sessile colorectal polyps, potentially reducing the need for surgery.
How similar studies have performed: Other studies have shown success with similar approaches, particularly in the use of EMR for managing large sessile lesions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Westmead, New South Wales
- Westmead Endoscopy Unit — Westmead, New South Wales, Australia (Recruiting)
Study contacts
- Study coordinator: Michael Bourke, MBBS
- Email: michael@citywestgastro.com.au
- Phone: 88905555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.