Systematic Wide-Field EMR Scar Assessment and Therapy Audit

NCT ID: NCT02617992

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Polyps

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EMR Surveillance

Patients who are referred for Endoscopic Mucosal Resection of Upper Gastrointestinal Lesions undertaking a surveillance visit will be included in this cohort.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western Sydney Local Health District

OTHER

Sponsor Role lead

Responsible Party

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Professor Michael Bourke

Director of Gastrointestinal Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Bourke, MBBS

Role: PRINCIPAL_INVESTIGATOR

Western Sydney Local Health District

Locations

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Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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HREC2013/8/6.5 (3796)

Identifier Type: -

Identifier Source: org_study_id

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