Endoscopic treatment for large colorectal lesions
Endoscopic Submucosal Dissection for Sessile Polyps and Laterally Spreading Lesions of the Colorectum Using a Selective Strategy - a Prospective Cohort Study
This study is testing new ways to safely remove large growths in the colon that could turn into cancer to see if it helps avoid more serious surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 391 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western Sydney Local Health District Academic / other |
| Locations | 1 site (Westmead, New South Wales) |
| Trial ID | NCT04008407 on ClinicalTrials.gov |
What this trial studies
This study focuses on the endoscopic management of large laterally spreading lesions (LSL) in the colon, which are at high risk of progressing to cancer. It aims to evaluate the effectiveness of endoscopic submucosal dissection and endoscopic mucosal resection techniques in safely removing these lesions. The study will assess the risk factors associated with submucosal invasive cancer in LSLs and aims to improve histological staging while potentially reducing the need for surgical resection. By utilizing advanced endoscopic imaging techniques, the study seeks to identify lesions that may harbor cancer without overt signs.
Who should consider this trial
Good fit: Ideal candidates for this study are patients referred for colorectal resection of large laterally spreading lesions who can provide informed consent.
Not a fit: Patients with previous resections of the target lesion, invasive malignancy, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of colorectal cancer by enabling early detection and removal of precancerous lesions.
How similar studies have performed: Other studies have shown promising results with endoscopic techniques for managing colorectal lesions, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients referred for colorectal resection of large laterally spreading lesions in colon. * Can give informed consent to trial participation Exclusion Criteria: * Previous resection or attempted resection of target adenoma lesion * Endoscopic appearance of invasive malignancy * Age less than 18 years * Pregnancy * Active Inflammatory colonic conditions (e.g. inflammatory bowel disease) * Use of anticoagulant or antiplatelet agents other than aspirin outside of internationally recognised guidelines * American Society of Anesthesiology (ASA) Grade IV-V
Where this trial is running
Westmead, New South Wales
- Westmead Endoscopy Unit — Westmead, New South Wales, Australia (Recruiting)
Study contacts
- Study coordinator: Michael J Bourke, MBBS
- Email: endoscopyresearch.westmead@gmail.com
- Phone: +61288905555
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.