Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cold EMR
Procedure/SurgeryCold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared.
Hybrid EMR
Procedure/SurgeryCold 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.
Treatment groups
194 Participants
are divided into 2 treatment groupsGroup A: Cold EMRActive comparator 1 intervention
Group B: Hybrid cold EMRExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence of polyps
Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy
Time frame
3-6 months after the procedureSecondary outcomes
1
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
Time frame
3-6 months after the procedure2
Polyp recurrence rates
Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy
Time frame
3-6 months after EMR procedure3
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.
Time frame
3-6 months after the procedure4
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
Time frame
3-6 months after the procedureSponsors and contacts
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Source ClinicalTrials.gov