CSPR vs Cold EMR for Colon Polyps

(CARDINAL Trial)

Overseen By Lainna R Cohen, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Ulcerative colitis, Crohn's disease, polyposis, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

570 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cold Snare Endoscopic Mucosal Resection for colon polyps?

Cold Snare Endoscopic Mucosal Resection (CS-EMR) is considered effective and safe for removing colon polyps, especially those 10 mm or larger, as it reduces risks associated with heat-based methods and has been shown to be non-inferior to traditional hot snare methods. ^{1 2 3 4 5}

Is cold snare endoscopic mucosal resection (CS-EMR) safe for removing colon polyps?

Research shows that cold snare endoscopic mucosal resection (CS-EMR) is generally safe for removing colon polyps, as it reduces risks associated with electrocautery, such as bleeding and other complications. ^{1 4 5 6 7}

How does the treatment Cold Snare Endoscopic Mucosal Resection differ from other treatments for colon polyps?

Cold Snare Endoscopic Mucosal Resection (CS-EMR) is unique because it removes colon polyps without using heat, reducing the risk of complications like bleeding and damage to surrounding tissues. It combines a cold snare technique with submucosal injection to improve the complete removal of polyps, making it a safer alternative to traditional methods that use heat. ^{1 2 4 5 6}

Research Team

John J Guardiola, MD

Principal Investigator

Indiana University

Eligibility Criteria

Adults undergoing colonoscopy who have a sessile serrated lesion or hyperplastic polyp ≥ 10 mm, or a conventional adenoma sized 10-19 mm. Not for those with polyps in locations hard to reach endoscopically, stalked polyps, signs of deeper invasion, or with Ulcerative Colitis/Crohn's disease.

Inclusion Criteria

I am going for a colonoscopy.

I have a large polyp or adenoma found during a procedure.

Ability to provide informed consent

Exclusion Criteria

I have polyps that can't be removed with a scope due to their location.

My polyps are attached to my colon by a stalk.

Polyps confirmed to be anything other than conventional adenoma on histologic diagnosis (Adenoma Cohort)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cold snare piecemeal resection (CSPR) or cold endoscopic mucosal resection (Cold EMR) for colorectal adenomas or serrated lesions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and recurrence of polyps at follow-up colonoscopy

6 to 12 months

1 visit (in-person)

Treatment Details

Interventions

• Cold Snare Endoscopic Mucosal Resection
• Cold Snare Piecemeal Resection

Trial Overview The trial compares two methods of removing certain types of colon polyps: Cold Snare Piecemeal Resection (CSPR) and Cold Endoscopic Mucosal Resection (Cold EMR), focusing on different sizes and types of lesions.

Participant Groups

Group I: Cold Snare Piecemeal Resection (CSPR) Experimental Treatment 1 Intervention

Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using CSPR technique.

Group II: Cold Snare Endoscopic Mucosal Resection (Cold EMR) Experimental Treatment 1 Intervention

Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using Cold EMR technique.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Rush University Medical Center

Collaborator

Trials

448

Recruited

247,000+

Carilion Clinic

Collaborator

Trials

85

Recruited

15,400+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

John D. Dingell VA Medical Center

Collaborator

Trials

10

Recruited

1,100+

White River Junction Veterans Affairs Medical Center

Collaborator

Trials

32

Recruited

17,900+

The University of Kansas Medical Center

Collaborator

Trials

3

Recruited

870+

Vancouver Coastal Health

Collaborator

Trials

41

Recruited

717,000+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

References

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

Efficacy and safety of cold-snare endoscopic mucosal resection for colorectal adenomas 10 to 14 mm in size: a prospective observational study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Endoscopic mucosal resection using cold snare versus hot snare in treatment for 10-19 mm non-pedunculated colorectal polyps: protocol of a non-inferiority randomised controlled study. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Cold versus hot endoscopic mucosal resection for nonpedunculated colorectal polyps sized 6-10 mm: a randomized trial. [2019]

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

Cold snare polypectomy versus cold endoscopic mucosal resection for small colorectal polyps: a multicenter randomized controlled trial. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

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

6. Australia pubmed.ncbi.nlm.nih.gov

The efficacy and safety of cold snare polypectomy with submucosal injection for the removal of polyps less than 20 mm in size: a systematic review and meta-analysis. [2023]

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

Cold snare piecemeal EMR of large sessile colonic polyps ≥20 mm (with video). [2021]