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)
Study Type
OBSERVATIONAL
Enrollment
342
AdventHealth
Orlando, Florida, United States
RECRUITINGAdenoma 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.
Time frame: 3 - 12 (+/- 6 months)
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.
Time frame: During procedure visit
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.
Time frame: Index procedure visit
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
Time frame: Index procedure, 1 - 3 days post, 30 days.
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).
Time frame: Index procedure, 1 - 3 days post, 30 days.
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Incidence of overall severe adverse events: Postpolypectomy Syndrome
Abdominal pain severe enough to warrant emergency room or hospital admission in the presence of fever, leukocytosis, peritoneal inflammation in the absence of frank perforation on CT, and/or required treatment with antibiotics.
Time frame: Index procedure, 1 - 3 days post, 30 days.