Clinical trial NCT06476145: Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation
Official title: Prospective Randomized Controlled Trial Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenoma Colon Polyp
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: White River Junction Veterans Affairs Medical Center
name: Rush University
name: University Medical Centre Ljubljana
name: University of Kansas
name: Henry Ford Health System
name: Carilion Clinic
name: St. Paul's Hospital, Canada
name: Minneapolis Veterans Affairs Medical Center
First posted: 2024-06-26
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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)


Eligibility criteria: 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

Primary outcomes:
measure: Adenoma Reocurrance
timeFrame: 3 - 12 (+/- 6 months)
Secondary outcomes:
measure: EMR procedure time
timeFrame: During procedure visit
measure: Comparison of MM vs STSC procedure time
timeFrame: Index procedure visit
measure: Incidence of overall severe adverse events: Bleeding
timeFrame: Index procedure, 1 - 3 days post, 30 days.
measure: Incidence of overall severe adverse events: Perforation
timeFrame: Index procedure, 1 - 3 days post, 30 days.
measure: Incidence of overall severe adverse events: Postpolypectomy Syndrome
timeFrame: Index procedure, 1 - 3 days post, 30 days.
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth
state: Florida
Study officials:
affiliation: AdventHealth
name: Dennis Yang, MD
role: PRINCIPAL_INVESTIGATOR
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