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The goal of this randomized clinical trial is to learn if a combination of hot and cold EMR technique is associated with a lower risk of polyp recurrence without increasing the risk of complication when removing large polyps.
Participants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold EMR | Active Comparator | Control group patients that receive standard cold EMR treatment. |
|
| Hybrid cold EMR | Experimental | Intervention group patients. Patients will receive hybrid EMR treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold EMR | Procedure | Cold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of polyps | Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy | 3-6 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Composite of clinically important adverse events: (1) Perforation requiring hospitalization or surgery (2) Bleeding associated with at least 2-gram Hb drop or hospitalization or Intervention (3) Post-polypectomy syndrome requiring hospital admission | 3-6 months after the procedure |
| Polyp recurrence rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Akram Ahmad, M.D. | Contact | 954-659-5000 | ahmada5@ccf.org | |
| Michael Nicolas, B.S. | Contact | 9546596213 | nicolam4@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Tilak Shah, M.D. | Cleveland Clinic Florida (Weston Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Weston | Recruiting | Weston | Florida | 33331 | United States |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Hybrid EMR | Procedure | Cold EMR with hot avulsion of any visible residual neoplasia within the resection bed, in addition to precise APC of the fibrotic bands that may harbor invisible neoplasia within the resection bed. |
|
Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy |
| 3-6 months after EMR procedure |
| Cost benefit analysis | - Cost-benefit analysis includes the costs of additional hospitalizations related to post-procedure complications and the cost of additional colonoscopies required to follow up treatment of recurrence. Costs will be calculated from a Medicare perspective. | 3-6 months after the procedure |
| Subgroup polyp recurrence rate | - Recurrence rates in the subgroup of patients with visible residual neoplasia after snare resection before utilizing forceps or cautery resection/ablation | 3-6 months after the procedure |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|