Prospective Randomized Controlled Trial Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation
Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:
• 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
Locations
United States
Florida
AdventHealth
RECRUITING
Orlando
Contact Information
Primary
Diana Paredes, RN
Diana.Paredes@adventhealth.com
407-303-5503
Backup
Petronio Martins, MHA
Petronio.martins@adventhealth.com
407-303-5503
Time Frame
Start Date: 2023-12-08
Estimated Completion Date: 2026-03-08
Participants
Target number of participants: 342
Treatments
EMR-MM
Mucosal markings are placed clearly outside the visible margin of the lesion (polyp) by placing superficial cautery marks with the tip of the endoscopic snare approximately 3 mm away from the polyp margin. Successful marking with diathermy is established by visual identification of white circular dots around the entire outer border of the lesion. EMR is then performed as per standard technique as described above.
EMR-STSC
Endoscopic mucosal resection with thermal margin ablation (STSC) will be performed of the entire margin of the mucosal defect, by using a light touch with 1 to 2 mm of the exposed snare tip aiming to create a 2 to 3 mm rim of completely ablated tissue around the entire circumference of the resection defect. Successful STSC is confirmed by the presence of a rim of whitening mucosa around the defect
Related Therapeutic Areas
Sponsors
Leads: AdventHealth
Collaborators: St. Paul's Hospital, Canada, University Medical Centre Ljubljana, Northwestern University, Carilion Clinic, Rush University, Minneapolis Veterans Affairs Medical Center, White River Junction Veterans Affairs Medical Center, University of Kansas, Henry Ford Health System