NCT04008407 ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study
| NCT ID | NCT04008407 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Western Sydney Local Health District |
| Condition | Colorectal Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 391 participants |
| Start Date | 2017-08-14 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 391 participants in total. It began in 2017-08-14 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04008407 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04008407 currently recruiting?
Yes, NCT04008407 is actively recruiting participants. Contact the research team at endoscopyresearch.westmead@gmail.com for enrollment information.
Where is the NCT04008407 trial being conducted?
This trial is being conducted at Westmead, Australia.
Who is sponsoring the NCT04008407 clinical trial?
NCT04008407 is sponsored by Western Sydney Local Health District. The trial plans to enroll 391 participants.