Skip to content

Systematic Wide-Field EMR Scar Assessment and Therapy Audit

Systematic Wide-Field EMR Scar Assessment and Therapy Audit

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02617992
Acronym
SANT
Enrollment
200
Registered
2015-12-01
Start date
2013-09-30
Completion date
2015-09-30
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyps

Brief 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.

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.

Interventions

None listed

Sponsors

Western Sydney Local Health District
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of post-EMR recurrenceone yearPresence of post-EMR recurrence

Secondary

MeasureTime frameDescription
Scar sizeone yearScar size (maximum dimension)
Presence of post EMR scar with clip artifactone yearPresence of post EMR scar with clip artifact, recognized as one or more nodule within the scar with a normal pit pattern
Number of sites of recurrenceone yearNumber of sites of recurrence (unifocal, 2 sites, 3 or more sites)
Histological characteristics of post-EMR scar biopsiesone year
Morphology of recurrenceone yearMorphology of recurrence (flat or elevated)
Kudo pit pattern assessmentone yearKudo pit pattern and whether the pit pattern of recurrence is only seen with NBI
NICE classificationone yearAs recurrence is diminutive the NICE classification is also applied and so the NBI appearance of recurrence (darker or lighter than the scar) is noted.
Location of recurrenceone yearLocation of recurrence (edge of the scar, within the scar or both)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026