Evaluating adenoma recurrence after specific endoscopic procedures
Prospective Randomized Controlled Trial Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation
This study is testing which of two different techniques for removing large colon polyps helps prevent the return of adenomas in adults who are having a colonoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 342 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AdventHealth Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT06476145 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the recurrence rates of adenomas in non-pedunculated colonic lesions following two different endoscopic mucosal resection techniques: one with margin marking and the other with thermal margin ablation. Patients aged 18 and older, who are scheduled for colonoscopy to evaluate and remove colon polyps of 20 mm or larger, will be included. The study will assess the effectiveness of these techniques in preventing adenoma recurrence, providing valuable insights into optimal treatment approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-pedunculated colon polyps that are 20 mm or larger.
Not a fit: Patients with pedunculated polyps, inflammatory bowel disease, or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing adenoma recurrence in patients undergoing colon polyp removal.
How similar studies have performed: While this study explores a comparative approach, similar studies have shown promise in evaluating endoscopic techniques for adenoma management.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orlando, Florida
- AdventHealth — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Dennis Yang, MD — AdventHealth
- Study coordinator: Diana Paredes, RN
- Email: Diana.Paredes@adventhealth.com
- Phone: 407-303-5503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.