Systematic Wide-Field EMR Scar Assessment and Therapy Audit

Polyps Clinical Trial

— SANT  

Official title:

Systematic Wide-Field EMR Scar Assessment and Therapy Audit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617992
• Other study ID #: HREC2013/8/6.5 (3796)
• Status: Completed
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: March 2021
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Polyps

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Western Sydney Local Health District

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of post-EMR recurrence	Presence of post-EMR recurrence	one year
Secondary	Histological characteristics of post-EMR scar biopsies		one year
Secondary	Scar size	Scar size (maximum dimension)	one year
Secondary	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	one year
Secondary	Number of sites of recurrence	Number of sites of recurrence (unifocal, 2 sites, 3 or more sites)	one year
Secondary	Location of recurrence	Location of recurrence (edge of the scar, within the scar or both)	one year
Secondary	Morphology of recurrence	Morphology of recurrence (flat or elevated)	one year
Secondary	Kudo pit pattern assessment	Kudo pit pattern and whether the pit pattern of recurrence is only seen with NBI	one year
Secondary	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.	one year