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OpenTrials
Completed

NCT Number: NCT02617992

Systematic Wide-Field EMR Scar Assessment and Therapy Audit

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Presence of post-EMR recurrence

    Time frame: one year

    Presence of post-EMR recurrence

Secondary outcomes

  1. Histological characteristics of post-EMR scar biopsies

    Time frame: one year

  2. Scar size

    Time frame: one year

    Scar size (maximum dimension)

  3. 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

  4. Number of sites of recurrence

    Time frame: one year

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

  5. Location of recurrence

    Time frame: one year

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

  6. Morphology of recurrence

    Time frame: one year

    Morphology of recurrence (flat or elevated)

  7. Kudo pit pattern assessment

    Time frame: one year

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

  8. 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.

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Acronym: SANT

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2015
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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