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Endoscopic Mucosal Resection

Cold vs Hot Snare EMR for Colonic Polyps (LPS-II Trial)

N/A
Recruiting
Research Sponsored by White River Junction Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any patient ≥18 who presents for a colonoscopy and who does not have criteria for exclusion
Patients with a ≥20mm non-pedunculated colorectal polyp
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at surveillance colonoscopies up to 5 years following the initial polyp resection
Awards & highlights

LPS-II Trial Summary

This trial is testing two different approaches to endoscopic mucosal resection (EMR) of large colorectal polyps. One approach uses electrocautery ("hot" snare EMR), and the other doesn't ("cold" snare EMR). Half of the patients will have their polyps removed using Eleview as the submucosal injection agent, and the other half will have their polyps removed using placebo (normal saline with methylene blue) as the submucosal injection agent.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include bleeding or perforation of the colon from the resection procedure. There might also be reactions to the submucosal injections such as local irritation or allergic reaction.

LPS-II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and eligible for a colonoscopy without any exclusion criteria.
Select...
I have a large colorectal polyp that is not on a stalk.

LPS-II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at surveillance colonoscopies up to 5 years following the initial polyp resection
This trial's timeline: 3 weeks for screening, Varies for treatment, and at surveillance colonoscopies up to 5 years following the initial polyp resection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Severe Adverse Events
Secondary outcome measures
Completeness of polyp resection
Crossover from cold to hot snare
Efficacy of submucosal injectate
+5 more

LPS-II Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Cold snare & Eleview injectionExperimental Treatment2 Interventions
Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview
Group II: Cold Snare & Placebo injectionExperimental Treatment2 Interventions
Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo
Group III: Hot snare & Placebo injectionActive Control2 Interventions
Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo
Group IV: Hot snare & Eleview injectionActive Control2 Interventions
Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo injection
2016
Completed Phase 4
~4080

Find a Location

Who is running the clinical trial?

White River Junction Veterans Affairs Medical CenterLead Sponsor
28 Previous Clinical Trials
16,011 Total Patients Enrolled
1 Trials studying Colorectal Adenomas
1,000 Patients Enrolled for Colorectal Adenomas
Dartmouth CollegeOTHER
79 Previous Clinical Trials
1,414,704 Total Patients Enrolled
US EndoscopyIndustry Sponsor
3 Previous Clinical Trials
958 Total Patients Enrolled
1 Trials studying Colorectal Adenomas
592 Patients Enrolled for Colorectal Adenomas

Media Library

Cold snare EMR (Endoscopic Mucosal Resection) Clinical Trial Eligibility Overview. Trial Name: NCT03865537 — N/A
Colorectal Adenomas Research Study Groups: Cold snare & Eleview injection, Hot snare & Placebo injection, Hot snare & Eleview injection, Cold Snare & Placebo injection
Colorectal Adenomas Clinical Trial 2023: Cold snare EMR Highlights & Side Effects. Trial Name: NCT03865537 — N/A
Cold snare EMR (Endoscopic Mucosal Resection) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03865537 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants being welcomed into this trial?

"According to clinicaltrials.gov, the trial is in its active recruitment period; it was originally posted on October 1st 2019 and recently updated on May 28th 2021."

Answered by AI

How many participants are allocated to this research endeavor?

"Affirmative. Per the clinicaltrials.gov information, this trial is currently in search of participants and was posted on October 1st 2019 with an update occurring on May 28th 2021. A total of 870 patients are being sought from a single site for enrolment."

Answered by AI
~161 spots leftby Mar 2025