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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02957058

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
PROSpective Assessment of Post EmR Recurrence
Scientific title
A Prospective Study Stratifying Patients to Follow up Intervals Based on Risk of Recurrence Post Wide Field Colonic EMR
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Adenoma 0 0
Colonic Polyp 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Study type
Description of intervention(s) / exposure
Treatment: Surgery - SCAR technique

Active Comparator: SERT 0, SCAR (low risk) - Patients with Sydney EMR Recurrence Tool (SERT scoring) score 0. These patients will be invited to return for follow up at 18 months and will have thermal ablation (SCAR technique) of the endoscopic resection defect margin.

Active Comparator: SERT 1-4, SCAR (high risk) - Patients with Sydney EMR Recurrence Tool score 1-4 (SERT scoring). These patients will be invited to return for follow up at 4-6 months and will have thermal ablation (SCAR technique) of the endoscopic resection defect margin.

Treatment: Surgery: SCAR technique
Thermal ablation of the EMR margin using ERBE Soft Coagulation (Effect 4, 80 watts) and the operator choice of endoscopic resection snare

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Adenoma recurrence - Recurrence of adenoma at first and second surveillance colonoscopy
Timepoint [1] 0 0
Variable dependent on SERT score
Secondary outcome [1] 0 0
Need for surgery - need for surgery due to adenoma recurrence or complication
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Bleeding after EMR
Timepoint [2] 0 0
2 weeks
Secondary outcome [3] 0 0
Pain after EMR
Timepoint [3] 0 0
2 weeks
Secondary outcome [4] 0 0
Delayed perforation after EMR
Timepoint [4] 0 0
2 weeks

Key inclusion criteria
- All laterally spreading lesions >= 20mm referred to the named tertiary referral

- Must consent to involvement
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Histology other than specified

- Lesion involving the ileocaecal valve

- Pregnancy: currently pregnant or attempting to become pregnant

- Lactation: currently breastfeeding

- Taken clopidogrel within 7 days

- Taken warfarin within 5 days

- Had full therapeutic dose unfractionated heparin within 6 hours

- Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours

- Known clotting disorder

- Previous attempt at EMR of the polyp referred for resection

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Primary sponsor type
Western Sydney Local Health District

Ethics approval
Ethics application status

Brief summary
To prospectively validate the SERT (Sydney EMR Recurrence Tool) scoring system for adenoma
recurrence rates around the endoscopic mucosal resection (EMR) scar after wide field-EMR with
thermal treatment applied to the defect margin. The primary aim of the study will be to
ensure the safety of this approach and there will be constant monitoring to ensure that this
is the case.
Trial website
Trial related presentations / publications
Public notes

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
Michael Bourke
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02957058