Adenoma Colon Polyp
Conditions
Brief summary
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)
Interventions
None listed
Sponsors
Northwestern University
White River Junction Veterans Affairs Medical Center
Rush University
University Medical Centre Ljubljana
University of Kansas
Henry Ford Health System
Carilion Clinic
St. Paul's Hospital, Canada
Minneapolis Veterans Affairs Medical Center
AdventHealth
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Age 18 years or older 2. Ability to provide informed consent 3. Patient scheduled to undergo colonoscopy for the evaluation and removal of colon polyps 4. Non-pedunculated polyps ≥ 20 mm size
Exclusion criteria
1. Pedunculated polyps 2. Inflammatory bowel disease 3. Inability to provide informed consent 4. Lesions \< 20 mm in size (largest dimension) 5. Lesion involves the lips of the ileocecal valve, is located at the appendiceal orifice and/or is fully circumferential. 6. Any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Reocurrance | 3 - 12 (+/- 6 months) | 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
| Measure | Time frame | Description |
|---|---|---|
| EMR procedure time | During procedure visit | 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 | Index procedure visit | 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 | Index procedure, 1 - 3 days post, 30 days. | 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 | Index procedure, 1 - 3 days post, 30 days. | Defined as complete hole, or full-thickness resection of the muscularis propria (Sidney classification of deep mural injury type IV or V). |
| Incidence of overall severe adverse events: Postpolypectomy Syndrome | Index procedure, 1 - 3 days post, 30 days. | 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. |
Countries
United States
Contacts
Primary ContactDiana Paredes, RN
Backup ContactPetronio Martins, MHA
Outcome results
None listed