Polyps Clinical Trial
— SANTOfficial title:
Systematic Wide-Field EMR Scar Assessment and Therapy Audit
Verified date | March 2021 |
Source | Western Sydney Local Health District |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The development of a standardised imaging protocol to detect post endoscopic mucosal resection (EMR) recurrence or residual adenoma through the comparison of biopsies of the post EMR scar with endoscopic findings.
Status | Completed |
Enrollment | 200 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing surveillance colonoscopy of a previously resected large sessile colonic polyp or laterally spreading tumour =20mm in size. - Age > 18 years - Able to give informed consent to involvement in the clinical study Exclusion Criteria: - Unable to provide informed consent for involvement |
Country | Name | City | State |
---|---|---|---|
Australia | Westmead Hospital | Westmead | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Western Sydney Local Health District |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of post-EMR recurrence | Presence of post-EMR recurrence | one year | |
Secondary | Histological characteristics of post-EMR scar biopsies | one year | ||
Secondary | Scar size | Scar size (maximum dimension) | one year | |
Secondary | Presence of post EMR scar with clip artifact | Presence of post EMR scar with clip artifact, recognized as one or more nodule within the scar with a normal pit pattern | one year | |
Secondary | Number of sites of recurrence | Number of sites of recurrence (unifocal, 2 sites, 3 or more sites) | one year | |
Secondary | Location of recurrence | Location of recurrence (edge of the scar, within the scar or both) | one year | |
Secondary | Morphology of recurrence | Morphology of recurrence (flat or elevated) | one year | |
Secondary | Kudo pit pattern assessment | Kudo pit pattern and whether the pit pattern of recurrence is only seen with NBI | one year | |
Secondary | NICE classification | As recurrence is diminutive the NICE classification is also applied and so the NBI appearance of recurrence (darker or lighter than the scar) is noted. | one year |
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