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

Study acronym: COVERT
StatusRecruiting
PhaseNot applicable
Started2017-08-14
View on ClinicalTrials.gov ↗

Amendment history

2025-03-25
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 1 site
2024-07-22
Study Status v5
Re-verified, no change to tracked fields
2023-06-28
Study Status v4
Primary completion date2022-08→2027-08
Completion date2023-08→2028-02
2021-10-04
Study Status v3
Primary completion date2021-08→2022-08
Completion date2021-08→2023-08
2021-03-21
Study Status v2
Primary completion date2021-08-31→2021-08
Completion date2021-08-31→2021-08
2019-07-08
Study Status, Study Description v1
Study description+30 characters
[...] re there is concern for sub-mucosal invasive cancer (SMIC). WeThe investigators propose a selective ESD strategy to be performed for patien [...] d those at high risk of covert SMIC (defined as risk >10%). WeThe investigators will follow a prospective cohort study assessing the use of [...]
2019-07-03
Original filing
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.
Trial Details
NCT Number NCT04008407
Lead Sponsor Western Sydney Local Health District
Conditions Colorectal Neoplasm, Endoscopic Mucosal Resection
Enrollment 391 participants
Start Date 2017-08-14
Primary Completion 2027-08 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2025-03-27