Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation

Conditions

• Adenoma Colon Polyp

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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)

Key Dates

Start date

Dec 8, 2023

Status verified

Nov 2025

Primary completion

May 30, 2026

Completion

Jan 8, 2027

Study Design

Enrollment

342 participants (estimated)

Arms

• Arm: 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.
• Arm: 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

Primary Outcome Measure

Adenoma Reocurrance [ Time Frame: 3 - 12 (+/- 6 months) ]

Central Contacts

• Diana Paredes, RN
  407-303-5503
  [email protected]
• Petronio Martins, MHA
  407-303-5503
  [email protected]

Locations (1)

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