Systematic Wide-Field EMR Scar Assessment and Therapy Audit (SANT)

March 22, 2021 updated by: Professor Michael Bourke, Western Sydney Local Health District
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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have had endoscopic mucosal resection of colonic polyps that are undergoing surveillance colonoscopy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of post-EMR recurrence
Time Frame: one year
Presence of post-EMR recurrence
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological characteristics of post-EMR scar biopsies
Time Frame: one year
one year
Scar size
Time Frame: one year
Scar size (maximum dimension)
one year
Presence of post EMR scar with clip artifact
Time Frame: one year
Presence of post EMR scar with clip artifact, recognized as one or more nodule within the scar with a normal pit pattern
one year
Number of sites of recurrence
Time Frame: one year
Number of sites of recurrence (unifocal, 2 sites, 3 or more sites)
one year
Location of recurrence
Time Frame: one year
Location of recurrence (edge of the scar, within the scar or both)
one year
Morphology of recurrence
Time Frame: one year
Morphology of recurrence (flat or elevated)
one year
Kudo pit pattern assessment
Time Frame: one year
Kudo pit pattern and whether the pit pattern of recurrence is only seen with NBI
one year
NICE classification
Time Frame: one year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Sydney Local Health District

Investigators

  • Principal Investigator: Michael Bourke, MBBS, Western Sydney Local Health District

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 8, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • HREC2013/8/6.5 (3796)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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