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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02617992
Other study ID # HREC2013/8/6.5 (3796)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2013
Est. completion date September 2015

Study information

Verified date March 2021
Source Western Sydney Local Health District
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

Removal of colonic polyps reduces colon cancer and although most polyps found are small, removal of large polyps can now be safely and effectively removed with wide field EMR. Residual polyp tissue is found at follow up colonoscopy in approximately 15% of cases however and remains a focus of attempts to improve EMR efficacy. All patients undergoing surveillance colonoscopy after EMR at Westmead Hospital Endoscopy unit will have steps of assessment and therapy of the scar recorded. Data will be entered into the large prospective audit database and also analysed separately. Data will be stored in coded format. The individual steps and the outcome of the scar interrogation and therapy will also be assessed and analysed. It is expected that these results will help guide the optimal approach to assessment and confirm the efficacy of therapy of recurrence further aiding the endoscopic approach to large colonic polyps.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Australia Westmead Hospital Westmead New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Western Sydney Local Health District

Country where clinical trial is conducted

Australia, 

Outcome

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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