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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02617992




Registration number
NCT02617992
Ethics application status
Date submitted
8/11/2015
Date registered
1/12/2015
Date last updated
11/07/2017

Titles & IDs
Public title
Systematic Wide-Field EMR Scar Assessment and Therapy Audit
Scientific title
Systematic Wide-Field EMR Scar Assessment and Therapy Audit
Secondary ID [1] 0 0
HREC2013/8/6.5 (3796)
Universal Trial Number (UTN)
Trial acronym
SANT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polyps 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
EMR Surveillance - Patients who are referred for Endoscopic Mucosal Resection of Upper Gastrointestinal Lesions undertaking a surveillance visit will be included in this cohort.

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of post-EMR recurrence - Presence of post-EMR recurrence
Timepoint [1] 0 0
one year
Secondary outcome [1] 0 0
Histological characteristics of post-EMR scar biopsies
Timepoint [1] 0 0
one year
Secondary outcome [2] 0 0
Scar size - Scar size (maximum dimension)
Timepoint [2] 0 0
one year
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
one year
Secondary outcome [4] 0 0
Number of sites of recurrence - Number of sites of recurrence (unifocal, 2 sites, 3 or more sites)
Timepoint [4] 0 0
one year
Secondary outcome [5] 0 0
Location of recurrence - Location of recurrence (edge of the scar, within the scar or both)
Timepoint [5] 0 0
one year
Secondary outcome [6] 0 0
Morphology of recurrence - Morphology of recurrence (flat or elevated)
Timepoint [6] 0 0
one year
Secondary outcome [7] 0 0
Kudo pit pattern assessment - Kudo pit pattern and whether the pit pattern of recurrence is only seen with NBI
Timepoint [7] 0 0
one year
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
one year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to provide informed consent for involvement

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02617992
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications