Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.

The Cleveland Clinic194 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

194

Conditions

Polyp of Colon Endoscopic Mucosal Resection

Interventions

Cold EMRPROCEDURE

Cold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared.

Hybrid EMRPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Cleveland Clinic Weston

Weston, Florida, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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 procedure

Secondary Outcomes

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 procedure

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 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.

Time frame: 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

Time frame: 3-6 months after the procedure

Central Contacts

Akram Ahmad, M.D.

CONTACT

954-659-5000 ahmada5@ccf.org

Michael Nicolas, B.S.

CONTACT

9546596213 nicolam4@ccf.org

Data from ClinicalTrials.gov

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