The Australian Colonic Large Sessile Lesion Endoscopic Resection Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorWestern Sydney Local Health District
About this trial
A prospective, multicentre, observational study of all patients referred for endoscopic resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat analysis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients referred for endoscopic resection of a large sessile colonic polyp or laterally spreading tumour ≥20mm in size.
Able to give informed consent to involvement in the clinical study
Disqualifiers
Unable to provide informed consent for involvement
Trial population
Patients referred for colonic EMR of a known sessile colonic polyp or laterally spreading lesion \>20mm in size
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 1 trial groupGroup A: Colonic polyp
Trial outcomes
Primary outcomes
1
Recurrence
Follow up colonoscopies as per standard of care for 6 - 60 months noting and treating any recurrence.
Time frame
6-60monthsSecondary outcomes
1
Technical success for Endoscopic resection
To determine the safety, efficacy and predictors of success for Endoscopic Mucosal Resection of large sessile colorectal polyps.
Time frame
6-60 months2
Cancer prediction
By properly assessing the lesion it is hoped that we will be able to provide the greater Gastroenterology community with a tool which can be used to properly identify benign and cancerous lesions to decrease the number of benign lesions being referred to surgery.
Time frame
peri-procedurallySponsors and contacts
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Source ClinicalTrials.gov