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

Recruiting now · Not applicable

Conditions studied: Colorectal Neoplasm, Endoscopic Mucosal Resection

In brief

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.

Key facts

Study ID

NCT04008407

Run by

Western Sydney Local Health District

People needed

391

Starts

2017-08-14

Expected to finish

2028-02-01

Last updated by the study team

2025-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients referred for colorectal resection of large laterally spreading lesions in colon.
• Can give informed consent to trial participation

You may not qualify if…

• 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

• Westmead Endoscopy Unit — Westmead, New South Wales, Australia (enrolling)

Full record on ClinicalTrials.gov

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