Systematic Wide-Field EMR Scar Assessment and Therapy Audit

Completed

• Conditions: Polyps

• Registration Number: NCT02617992
• Lead Sponsor: Western Sydney Local Health District

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.

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-11-08
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-12-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of post-EMR recurrence	one year	Presence of post-EMR recurrence

Secondary Outcome Measures

Name	Time	Method
Histological characteristics of post-EMR scar biopsies	one year
Presence of post EMR scar with clip artifact	one year	Presence 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 recurrence	one year	Number of sites of recurrence (unifocal, 2 sites, 3 or more sites)
Kudo pit pattern assessment	one year	Kudo pit pattern and whether the pit pattern of recurrence is only seen with NBI
NICE classification	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.
Scar size	one year	Scar size (maximum dimension)
Location of recurrence	one year	Location of recurrence (edge of the scar, within the scar or both)
Morphology of recurrence	one year	Morphology of recurrence (flat or elevated)

Trial Locations

Locations (1)

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia