NCT04008407Recruiting
ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study
Endoscopic Submucosal Dissection for Sessile Polyps and Laterally Spreading Lesions of the Colorectum Using a Selective Strategy - a Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 27 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 391 (estimated)
- First submitted
- 2 Jul 2019
- Start date
- 14 Aug 2017
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Western Sydney Local Health District
- Diseases
- Colorectal cancer
- NCT number
- NCT04008407
What you commit to
- Study type: Interventional
- Planned participants: 391
- From 14 Aug 2017 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous resection or attempted resection of target adenoma lesion
Other illness
- Endoscopic appearance of invasive malignancy
- Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
Age
- Age less than 18 years
Other
- Pregnancy
- Use of anticoagulant or antiplatelet agents other than aspirin outside of internationally recognised guidelines
- American Society of Anesthesiology (ASA) Grade IV-V
Who the study is looking for
- All patients referred for colorectal resection of large laterally spreading lesions in colon.
- Can give informed consent to trial participation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Westmead Endoscopy Unit Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.