Endoscopic Mucosal Resection, Polyp of Colon
Conditions
Keywords
EMR, Cold EMR, Hybrid EMR, Endoscopic mucosal resection
Brief summary
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.
Interventions
PROCEDURECold EMR
Cold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared.
PROCEDUREHybrid EMR
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.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient (age 18 years or older) * Polyp size of at least 20 mm * \- Morphology: Flat or superficially raised polyp morphology (i.e., Paris classification 1s, 0-IIa or 0-IIb, or a combination of the above)
Exclusion criteria
* Polyps with previous failed resection attempts or polyp recurrence * Suspected deep submucosal invasion on endoscopic assessment of surface mucosal pit pattern (Kudo V or NICE 3 pattern) or histologically confirmed malignancy (invasive adenocarcinoma) * Polyps with nodules too large (\>1-1.5cm) for the use of a cold snare * Inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of polyps | 3-6 months after the procedure | Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 3-6 months after the procedure | 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 |
| Polyp recurrence rates | 3-6 months after EMR procedure | Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy |
| Cost benefit analysis | 3-6 months after the procedure | \- 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. |
| Subgroup polyp recurrence rate | 3-6 months after the procedure | \- Recurrence rates in the subgroup of patients with visible residual neoplasia after snare resection before utilizing forceps or cautery resection/ablation |
Countries
United States
Contacts
CONTACTAkram Ahmad, M.D.
CONTACTMichael Nicolas, B.S.
PRINCIPAL_INVESTIGATORTilak Shah, M.D.
Cleveland Clinic Florida (Weston Hospital)
Outcome results
None listed