Cold vs Hybrid Cold EMR for Colon Polyps

Recruiting at 1 trial location

Overseen By Akram Ahmad, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Failed resection, Malignancy, Large nodules, IBD

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

194 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Cold vs Hybrid Cold EMR for Colon Polyps?

Cold endoscopic mucosal resection (EMR) is considered safer and more cost-effective than traditional hot EMR for large colon polyps, with fewer days of lost productivity and potential cost savings. However, polyp recurrence rates may be higher with cold EMR. ^{1 2 3 4 5}

Is Cold EMR safe for removing colon polyps?

Cold snare endoscopic mucosal resection (CS-EMR) is considered safe for removing colon polyps, with a low risk of complications like bleeding and post-polypectomy syndrome compared to hot snare methods. It is effective for polyps 6-20 mm in size and has a high rate of complete removal with minimal delayed complications. ^{1 6 7 8 9}

How does the Cold vs Hybrid Cold EMR treatment for colon polyps differ from other treatments?

Cold EMR and Hybrid Cold EMR are unique because they focus on removing colon polyps without using heat, which can reduce the risk of complications like bleeding. This approach is different from traditional methods that often use heat to remove polyps. ^{10 11 12 13 14}

What is the purpose of 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.

Research Team

Tilak Shah, M.D.

Principal Investigator

Cleveland Clinic Florida (Weston Hospital)

Eligibility Criteria

This trial is for adults over 18 with large colon polyps (at least 20mm) that are flat or slightly raised. It's not for those who've had failed polyp removals, suspected deep cancer invasion, very large nodules unsuitable for cold snare use, or inflammatory bowel disease.

Inclusion Criteria

Polyp size of at least 20 mm

My polyp is flat or slightly raised.

Exclusion Criteria

My tests show advanced cancer or confirmed invasive adenocarcinoma.

My polyps are too large for cold snare removal.

I have inflammatory bowel disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EMR using either cold or hybrid cold EMR techniques

Follow-up

Participants return for a follow-up endoscopy to check for polyp recurrence

3-6 months

Treatment Details

Interventions

• Cold EMR
• Hybrid EMR

Trial Overview The study compares two ways to remove colon polyps: Hybrid EMR (a mix of hot and cold techniques) and Cold EMR (no heat). The goal is to see if the hybrid method can prevent polyps from coming back without more complications.

Participant Groups

Group I: Hybrid cold EMR Experimental Treatment 1 Intervention

Intervention group patients. Patients will receive hybrid EMR treatment.

Group II: Cold EMR Active Control 1 Intervention

Control group patients that receive standard cold EMR treatment.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

References

1. Egypt pubmed.ncbi.nlm.nih.gov

A Review on the Quality of Colonoscopy Reporting. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Quality of endoscopy reporting at index colonoscopy significantly impacts outcome of subsequent EMR in patients with > 20 mm colon polyps. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Development of an Automated Algorithm to Generate Guideline-based Recommendations for Follow-up Colonoscopy. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Cold versus hot endoscopic mucosal resection for large sessile colon polyps: a cost-effectiveness analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A prediction model for advanced colorectal neoplasia in an asymptomatic screening population. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Outcome of EMR as an alternative to surgery in patients with complex colon polyps. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Cold snare endoscopic mucosal resection for colon polyps: a systematic review and meta-analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of three different endoscopic methods in treatment of 6-20 mm colorectal polyps. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Cold or Hot Snare with Endoscopic Mucosal Resection for 6-9 mm Colorectal Polyps: A Propensity Score Matching Analysis. [2022]

10. China pubmed.ncbi.nlm.nih.gov

Endocuff assisted colonoscopy significantly increases sessile serrated adenoma detection in veterans. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Artificial Intelligence-Aided Colonoscopy for Polyp Detection: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. [2021]

12. Denmark pubmed.ncbi.nlm.nih.gov

[Virtual colonoscopy is now reality]. [2016]

13. Germany pubmed.ncbi.nlm.nih.gov

Cuff-assisted versus cap-assisted colonoscopy for adenoma detection: results of a randomized study. [2020]

14. China pubmed.ncbi.nlm.nih.gov

Image enhanced colonoscopy: updates and prospects-a review. [2023]