990 Participants Needed

Cold vs Hot Snare EMR for Colonic Polyps

(LPS-II Trial)

AH
HP
Overseen ByHeiko Pohl, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: White River Junction Veterans Affairs Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.12356

Who Is on the Research Team?

HP

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

Inadequate bowel preparation (Boston Bowel Prep Scale, total score ≤2)
I have inflammatory bowel disease.
I have ulcerated lesions or confirmed adenocarcinoma.
See 6 more

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?
4Treatment groups
Experimental Treatment
Active Control
Group I: Cold snare & Eleview injectionExperimental Treatment2 Interventions
Group II: Cold Snare & Placebo injectionExperimental Treatment2 Interventions
Group III: Hot snare & Placebo injectionActive Control2 Interventions
Group IV: Hot snare & Eleview injectionActive Control2 Interventions

Find a Clinic Near You

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

Cold snare piecemeal EMR of large sessile colonic polyps ≥20 mm (with video). [2021]
Cold or Hot Snare with Endoscopic Mucosal Resection for 6-9 mm Colorectal Polyps: A Propensity Score Matching Analysis. [2022]
Cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial. [2022]
Cold versus hot endoscopic mucosal resection for nonpedunculated colorectal polyps sized 6-10 mm: a randomized trial. [2019]
Cold snare endoscopic resection of nonpedunculated colorectal polyps larger than 10 mm: a systematic review and pooled-analysis. [2019]
[A comparative study of cold snare and hot snare resection of small colorectal polyps]. [2018]
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