Cold vs Hot Snare EMR for Colonic Polyps

(LPS-II Trial)

Overseen By Heiko Pohl, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: White River Junction Veterans Affairs Medical Center

Disqualifiers: Inflammatory bowel disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: immediate

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best method for removing large, flat polyps from the colon. It compares two techniques: using a hot tool with electricity to cut the polyp (hot snare EMR) and a cold tool without electricity (cold snare EMR). The study also tests two different liquids injected under the polyp to lift it: a special solution called Eleview and a simple saline mix. This trial may suit those scheduled for a colonoscopy with a non-pedunculated (flat) polyp that is 20mm or larger. As an unphased trial, it offers a unique opportunity to contribute to medical knowledge and potentially improve future colonoscopy procedures.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cold snare EMR, a method for removing large polyps in the colon, is generally very safe. One study found it reduced the risk of major side effects by over 85% compared to hot snare EMR. Specifically, serious issues occurred in only about 1% of cases with cold snare, compared to nearly 8% with hot snare, making cold snare EMR a safer choice.

Hot snare EMR remains effective, but it carries a slightly higher risk of side effects, such as bleeding or other complications. Both methods are used to remove polyps, but cold snare EMR is preferred for safety, especially with larger polyps.

Overall, researchers continue to study both treatments to ensure their safety and effectiveness in different situations. For those considering participation in a clinical trial, these studies provide valuable information about what to expect regarding safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it directly compares cold and hot snare endoscopic mucosal resection (EMR) techniques for removing colonic polyps. Unlike the hot snare method, which uses electrocautery to cut and cauterize tissue, the cold snare technique removes polyps without heat, potentially reducing the risk of tissue damage and complications. Additionally, the trial explores the use of Eleview, an injectable solution that lifts polyps for easier removal, which could enhance precision and safety in both cold and hot snare techniques. This study aims to determine which method offers the best balance of effectiveness and safety, potentially refining standard practices for polyp removal.

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

This trial will compare different methods for endoscopic mucosal resection (EMR) of colonic polyps. Research has shown that using a cold snare for EMR is safer than a hot snare, with fewer major side effects. However, the cold snare method has about twice the chance of polyps returning compared to the hot method. Conversely, the hot snare method is highly effective, achieving a complete removal rate of 99.3% and a low chance of leftover polyps. Participants in this trial will be assigned to different arms to evaluate these methods: some will receive the cold snare EMR, while others will receive the hot snare EMR. Both methods have their pros and cons: the cold snare is safer but might lead to more polyps returning, while the hot snare is very effective but carries a slightly higher risk of side effects. ^{2 6 7 8 9}

Who Is on the Research Team?

Heiko Pohl, MD

Principal Investigator

White River Junction VAMC, Geisel School of Medicine at Dartmouth

Are You a Good Fit for This Trial?

This trial is for adults with large non-pedunculated colorectal polyps (≥20mm) who are undergoing a colonoscopy and have good general health. It's not for those with poor health, inadequate bowel prep, pedunculated or ulcerated depressed lesions, suspected deep cancer invasion, pregnancy, emergency procedures, coagulopathy or inflammatory bowel disease.

Inclusion Criteria

I am 18 or older and eligible for a colonoscopy without any exclusion criteria.

I have a large colorectal polyp that is not on a stalk.

Exclusion Criteria

I have inflammatory bowel disease.

Inadequate bowel preparation (Boston Bowel Prep Scale, total score ≤2)

I have ulcerated lesions or confirmed adenocarcinoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo polyp resection using either hot or cold snare EMR with submucosal injection of Eleview or placebo

immediate

1 visit (in-person)

Follow-up

Participants are monitored for severe adverse events and polyp recurrence

up to 30 days

1 visit (in-person)

Long-term Follow-up

Surveillance colonoscopies to monitor for polyp recurrence

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Cold snare EMR
• Eleview injection
• Hot snare EMR
• Placebo injection

Trial Overview The study compares two EMR techniques for removing large colorectal polyps: 'hot' snare using electrocautery and 'cold' snare without it. Additionally, it tests Eleview injection versus a placebo solution to see which is more effective in aiding the removal of these polyps.

How Is the Trial Designed?

Group I: Cold snare & Eleview injection Experimental Treatment 2 Interventions

Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview

Group II: Cold Snare & Placebo injection Experimental Treatment 2 Interventions

Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo

Group III: Hot snare & Placebo injection Active Control 2 Interventions

Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo

Group IV: Hot snare & Eleview injection Active Control 2 Interventions

Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview

Who Is Running the Clinical Trial?

White River Junction Veterans Affairs Medical Center

Lead Sponsor

Trials

32

Recruited

17,900+

Steris

Collaborator

Trials

1

Recruited

990+

Cosmo Pharmaceuticals

Collaborator

Trials

1

Recruited

990+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

US Endoscopy

Industry Sponsor

Trials

4

Recruited

1,900+

Aries Pharmaceuticals, Inc.

Collaborator

Trials

1

Recruited

990+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40393701/

Cold snare endoscopic resection for large colon polyps Results: 660 patients were randomised and analysed. An SAE was observed in 2.1% of patients in the cold EMR group and in 4.3% in the hot EMR group (p=0.10) (per ...

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

Cold EMR for large colon polyps However, cold EMR was associated with a 2-fold higher recurrence rate (28% vs. 14%). Recurrence was not significantly different for 20–29 mm ...

3. gastrojournal.org gastrojournal.org/article/S0016-5085(24)04935-7/fulltext

Cold Versus Hot Snare Endoscopic Resection of Large ... Cold resection of large, nonpedunculated colorectal polyps appears to be considerably safer than hot EMR; however, at the cost of a higher ...

4. 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.

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

Cold snare polypectomy versus cold endoscopic mucosal ... Our meta-analysis of seven RCTs showed that while both CSP and CEMR are equally safe and effective for resecting small (≤10 mm) colorectal ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36750222/

Effectiveness and safety of cold snare polypectomy and ... CSP/C-EMR for morphologically suitable nonpedunculated colonic polyps of 10-19 mm is effective and safe, including for conventional adenomas.

7. gi.org gi.org/journals-publications/ebgi/abuheija_dec2024/

Cold vs Hot Snare Resection of Large Polyps Cold snare EMR is significantly safer than hot snare EMR for large (> 2cm) non-pedunculated polyps with a reduction of major AEs by >85% (7.9% to 1.0%).

8. bmcgastroenterol.biomedcentral.com bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-04245-8

Efficacy and safety of cold snare polypectomy for outpatient ... Complications and 7-day postoperative outcomes were recorded. Results. A total of 194 sessile colorectal polyps < 10 mm were resected from 77 ...

9. cghjournal.org cghjournal.org/article/S1542-3565(24)00830-9/fulltext

Cold Snare Resection in the Colorectum: When to Choose ... Cold snaring is now the preferred resection method for the majority of colorectal polyps encountered during colonoscopy.