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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02957058
Ethics application status
Date submitted
3/11/2016
Date registered
6/11/2016
Date last updated
3/07/2023

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
AU RED HREC/16/WMEAD/130
Universal Trial Number (UTN)
Trial acronym
PROSPER
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

Intervention/exposure
Study type
Interventional
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

Outcomes
Primary outcome [1] 0 0
Adenoma recurrence
Timepoint [1] 0 0
Variable dependent on SERT score
Secondary outcome [1] 0 0
Need for surgery
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

Eligibility
Key inclusion criteria
* All laterally spreading lesions >= 20mm referred to the named tertiary referral centres
* Must consent to involvement
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2023
Sample size
Target
Accrual to date
Final
700
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
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
https://clinicaltrials.gov/study/NCT02957058
Trial related presentations / publications
Sidhu M, Shahidi N, Gupta S, Desomer L, Vosko S, Arnout van Hattem W, Hourigan LF, Lee EYT, Moss A, Raftopoulos S, Heitman SJ, Williams SJ, Zanati S, Tate DJ, Burgess N, Bourke MJ. Outcomes of Thermal Ablation of the Mucosal Defect Margin After Endoscopic Mucosal Resection: A Prospective, International, Multicenter Trial of 1000 Large Nonpedunculated Colorectal Polyps. Gastroenterology. 2021 Jul;161(1):163-170.e3. doi: 10.1053/j.gastro.2021.03.044. Epub 2021 Mar 31.
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

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