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CompletedNCT02617992SANTUpdated Mar 23, 2021

Systematic Wide-Field EMR Scar Assessment and Therapy Audit

An observational study in Polyps, sponsored by Western Sydney Local Health District. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-23.

Sponsored by Western Sydney Local Health District · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Polyps
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In context

Lead sponsor

Western Sydney Local Health District is the lead sponsor of 35 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Unable to provide informed consent for involvement
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • EMR Surveillance

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

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What researchers measure

Primary outcomes

  1. Presence of post-EMR recurrence

    Presence of post-EMR recurrence

    Time frame: one year

Secondary outcomes

  1. Histological characteristics of post-EMR scar biopsies

    Time frame: one year

  2. Scar size

    Scar size (maximum dimension)

    Time frame: one year

  3. 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

    Time frame: one year

  4. Number of sites of recurrence

    Number of sites of recurrence (unifocal, 2 sites, 3 or more sites)

    Time frame: one year

  5. Location of recurrence

    Location of recurrence (edge of the scar, within the scar or both)

    Time frame: one year

  6. Morphology of recurrence

    Morphology of recurrence (flat or elevated)

    Time frame: one year

  7. Kudo pit pattern assessment

    Kudo pit pattern and whether the pit pattern of recurrence is only seen with NBI

    Time frame: one year

  8. 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.

    Time frame: one year

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Study locations

1 site
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02617992
Lead sponsor
Western Sydney Local Health District
Responsible party
Professor Michael Bourke (Director of Gastrointestinal Endoscopy, Western Sydney Local Health District) — Principal investigator
First posted
Dec 1, 2015
Start date
Sep 2013
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Mar 23, 2021

Study contacts

Michael Bourke, MBBS
principal investigator · Western Sydney Local Health District

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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