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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for removing colon polyps, which are growths in the colon that can sometimes become cancerous. Researchers are testing cold snare piecemeal resection (CSPR) and cold snare endoscopic mucosal resection (Cold EMR) to determine which is more effective for polyps of certain sizes. The trial seeks participants undergoing a colonoscopy who have been diagnosed with a larger, flat-type (sessile) polyp that is 10 mm or larger. As an unphased trial, it offers patients the chance to contribute to medical knowledge and potentially benefit from innovative polyp removal techniques.

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 prior data suggests that these techniques are safe for removing colon polyps?

Research shows that both Cold Snare Piecemeal Resection (CSPR) and Cold Snare Endoscopic Mucosal Resection (Cold EMR) are generally safe for removing colon polyps.

For CSPR, studies report a 0% rate of serious side effects, indicating it is well-tolerated by patients. The chance of polyps returning is also low.

Cold EMR has a strong safety record as well. It is very safe for removing various types of colon polyps, including larger ones.

Overall, both treatments are considered safe options for removing colon polyps, with rare reports of issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing Cold Snare Piecemeal Resection (CSPR) and Cold Snare Endoscopic Mucosal Resection (Cold EMR) because these techniques offer a potentially safer and less invasive way to remove colon polyps. Traditional methods often use hot snares, which can lead to complications like bleeding or perforation. In contrast, both CSPR and Cold EMR use cold snares, which reduce the risk of thermal injury to the colon tissue. By refining these techniques, the trial aims to determine which method is more effective for removing larger polyps, providing valuable insights into improving patient outcomes during colonoscopies.

What evidence suggests that this trial's treatments could be effective for colon polyps?

This trial will compare Cold Snare Piecemeal Resection (CSPR) with Cold Snare Endoscopic Mucosal Resection (Cold EMR) for removing colon polyps. Research has shown that both CSPR and Cold EMR effectively remove colon polyps. Studies indicate that both techniques have a low likelihood of leaving behind polyp tissue or experiencing polyp recurrence. CSPR boasts a high success rate, with 100% of procedures technically successful and less than 5% of polyps recurring within 6 to 18 months. Cold EMR is recognized for its safety and effectiveness, particularly for medium-sized growths and larger, irregular tissue growths. Both methods are safe and effective, but their success can depend on the size and type of the polyp. ^{1 2 3 5 6}

Who Is on the Research Team?

John J Guardiola, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37451284/

Cold snare endoscopic mucosal resection for colon polyps CS-EMR demonstrated an excellent safety profile for colon polyps, with variable recurrence rates based on polyp size and histology.

2. gi.org gi.org/journals-publications/ebgi/bilal_aug2025/

Cold EMR for large colon polyps Is cold snare endoscopic mucosal resection (EMR) safer and more effective than hot EMR for removing large (≥ 20 mm) non-pedunculated ...

3. e-ce.org e-ce.org/journal/view.php?doi=10.5946/ce.2024.081

Cold snare polypectomy versus cold endoscopic mucosal ... We aimed to compare the outcomes of cold endoscopic mucosal resection (CEMR) with that of CSP for colorectal polyps ≤10 mm, using data from ...

4. giejournal.org giejournal.org/article/S0016-5107(24)03416-3/fulltext

Efficacy of cold piecemeal EMR of medium to large ... C-EMR seems to be less effective for the resection of large adenomas compared with medium adenomas or large SSLs. C-EMR is equally safe for all lesion sizes ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06462521

NCT06462521 | Cold Snare Piecemeal Resection vs ... 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: ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39970943/

Results of the CS-EMR 2019 randomized controlled trial Cold snare EMR (CS-EMR) in large flat non-pedunculated colonic lesions (LFNPCLs) is an alternative to the standard EMR procedure with a better safety profile.