RecruitingNot Applicable

ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study

Australia391 participantsStarted 2017-08-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of surgical referral

Timeframe: 3 months post procedure

Trial details

NCT IDNCT04008407

SponsorWestern Sydney Local Health District

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Michael J Bourke, MBBS

+61288905555 endoscopyresearch.westmead@gmail.com

View on ClinicalTrials.gov More Colorectal Neoplasm trials