What side effects are associated with this type of intervention?

The most common treatments for colorectal adenomas, such as Electrocautery (Hot Snare EMR) and Eleview (submucosal injection agent), have specific side effects. Electrocautery can cause bleeding, perforation, and post-polypectomy syndrome, which includes abdominal pain and fever. Eleview, used to elevate polyps for easier removal, may cause localized reactions such as swelling or minor bleeding at the injection site. Both treatments are generally safe but require careful monitoring for these potential complications.

What prior FDA approvals exist?

The FDA has approved several methods for the treatment of colorectal adenomas, including the use of electrocautery devices for hot snare endoscopic mucosal resection (EMR). These devices utilize electrical current for cutting and coagulation during polyp removal. Additionally, submucosal injection agents like Eleview, which is used to elevate polyps for easier and safer resection, have also received FDA approval. These treatments aim to improve the efficacy and safety of polyp removal procedures, reducing the risk of complications and recurrence.

What other types of research exist?

For colorectal adenomas, promising novel alternatives to Electrocautery (Hot Snare EMR) include Cold Snare EMR, which avoids the use of electrical current and reduces the risk of thermal injury. For submucosal injection agents, alternatives to Eleview include normal saline with methylene blue, which is used as a placebo in some trials, and other agents like hyaluronic acid or hydroxyethyl starch, which have been explored for their efficacy in creating a submucosal cushion and facilitating polyp resection.

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Endoscopic Mucosal Resection

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

N/A

Waitlist Available

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

Patients with a ≥20mm non-pedunculated colorectal polyp

Be older than 18 years old

Must not have

Patients with inflammatory bowel disease

Patients with ulcerated depressed lesions (as defined by Paris Classification type III) or confirmed adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at surveillance colonoscopies up to 5 years following the initial polyp resection

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have inflammatory bowel disease.

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I have ulcerated lesions or confirmed adenocarcinoma.

Select...

I am undergoing an emergency colonoscopy.

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My overall health is poor.

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My cancer is suspected to be deep within the lining of an organ.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at surveillance colonoscopies up to 5 years following the initial polyp resection

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Severe Adverse Events

Secondary study objectives

Completeness of polyp resection

Crossover from cold to hot snare

Efficacy of submucosal injectate

+5 more

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Electrocautery (Hot Snare EMR) uses electrical current to cut and coagulate tissue, allowing for precise removal of colorectal adenomas while minimizing bleeding. Eleview, a submucosal injection agent, is used to elevate the polyp, making it easier to resect and reducing the risk of perforation. These mechanisms are important for colorectal adenoma patients as they enhance the safety and efficacy of polyp removal, reducing recurrence rates and improving long-term outcomes.

Electrochemotherapy for colorectal cancer using endoscopic electroporation: a phase 1 clinical study.