About this trial
Non-inferiority trial comparing the recurrence rate of adenomas in non-pedunculated colonic lesions following endoscopic mucosal resection with margin marking (EMR-MM) and endoscopic mucosal resection with thermal margin ablation (EMR-STSC)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Ability to provide informed consent
Patient scheduled to undergo colonoscopy for the evaluation and removal of colon polyps
Non-pedunculated polyps ≥ 20 mm size
Disqualifiers
Pedunculated polyps
Inflammatory bowel disease
Inability to provide informed consent
Lesions < 20 mm in size (largest dimension)
Trial population
Primary Care Clinic
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Adenoma Reocurrance
During Screening Colonoscopy (SC) 1, between 3 -12 post initial procedure. The post-EMR site will be assessed and biopsied for histology to assess for recurrence of adenoma.
Secondary outcomes
EMR procedure time
Time from submucosal injection to completion of resection, including the time required to treat any intraprocedural adverse event, but not including time on prophylactic endoscopic closure.
Comparison of MM vs STSC procedure time
MM procedure time is defined as that required to complete placing cautery marks around the lesion prior to resection. STSC time is defined as that required to complete margin ablation around the entire resection margin.
Incidence of overall severe adverse events: Bleeding
Severe bleeding (immediate or delayed): defined as the need for hospitalization, transfusion, repeat endoscopy, surgery or interventional radiology. Immediate complication is defined as an event at the time of ESD resection or immediately following colonoscopy (before patient has left the endoscopy unit or during the immediate post-procedural care). A delayed (post-procedure) bleed is defined as an event that occurs after the patient has left the endoscopy unit and within 30 days following the procedure
Incidence of overall severe adverse events: Perforation
Defined as complete hole, or full-thickness resection of the muscularis propria (Sidney classification of deep mural injury type IV or V).
Sponsors and contacts
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AdventHealth
Lead sponsor
Northwestern University
Collaborator
White River Junction Veterans Affairs Medical Center
Collaborator
Rush University
Collaborator
University Medical Centre Ljubljana
Collaborator
University of Kansas
Collaborator
Henry Ford Health System
Collaborator
Carilion Clinic
Collaborator
St. Paul's Hospital, Canada
Collaborator
Minneapolis Veterans Affairs Medical Center
Collaborator