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

990 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two methods of removing large colon growths, one using heat and one without. It also compares two different solutions to make the removal easier. The study focuses on patients with large colon polyps because these are harder to remove and have more risks. The goal is to find out which method and solution are safer and more effective.

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 snare EMR, Eleview injection, Hot snare EMR, Placebo injection for colonic polyps?

Research shows that cold snare endoscopic mucosal resection (CS-EMR) is a safe and effective method for removing small to medium-sized colorectal polyps, with fewer complications and shorter hospital stays compared to hot snare EMR (HS-EMR). Cold snare techniques avoid the risks associated with electrocautery, making them a promising option for polyp removal. ^{1 2 3 4 5}

How does the treatment Cold vs Hot Snare EMR for Colonic Polyps differ from other treatments?

Cold snare EMR is unique because it avoids the use of heat, reducing the risk of electrocautery-induced damage, which is a concern with hot snare EMR. It is also associated with shorter operation times and lower costs, making it a safer and more efficient option for removing certain types of colonic polyps. ^{1 2 4 5 6}

Research Team

Heiko Pohl, MD

Principal Investigator

White River Junction VAMC, Geisel School of Medicine at Dartmouth

Eligibility Criteria

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

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

I have inflammatory bowel disease.

I have ulcerated lesions or confirmed adenocarcinoma.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

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

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

2. 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]

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

Cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial. [2022]

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

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

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

Cold snare endoscopic resection of nonpedunculated colorectal polyps larger than 10 mm: a systematic review and pooled-analysis. [2019]

6. China pubmed.ncbi.nlm.nih.gov

[A comparative study of cold snare and hot snare resection of small colorectal polyps]. [2018]