ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study
Recruiting · NCT04008407 · Interventional (participants receive a specific treatment) · Lead sponsor: Western Sydney Local Health District
View the official record on ClinicalTrials.gov →Interventions studied
Endoscopic Mucosal ResectionEndoscopic Submucosal Dissection
What this trial is about
Colonic Laterally spreading lesions (LSL) =\> 20mm are at high risk to progress to cancer. Overt stigmata of submucosal invasive cancer (SMIC) has been well characterized and includes ulceration and surface pit pattern changes as per the Kudo classification of type V. In a recent report, risk factors for LSL with SMIC and no overt stigmata (i.e. covert SMIC) were described. Resection of these lesions 'en-bloc' can allow for better histological staging and potentially reduce the need for surgical resection.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Westmead Endoscopy Unit - Westmead, New South Wales, Australia