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Colonic PolypLPS-IINCT03865537

Cold Snare Endoscopic Mucosal Resection Trial

A study testing Cold snare EMR, Hot snare EMR and Eleview injection in people with Colonic Polyp and Colonoscopy, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study compares different approaches to endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (≥20mm) in a 2 x 2 randomized design. The first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare EMR) and half of patient to polyp resection without… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colonic Polyp, Colonoscopy, Complication
What is being tested?
Cold snare EMR, Hot snare EMR and Eleview injection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
990 participants
Where
1 siteUnited States
Study dates
1 Oct 2019to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any patient ≥18 who presents for a colonoscopy and who does not have criteria for exclusion
  • Patients with a ≥20mm non-pedunculated colorectal polyp

Who cannot join

  • Pedunculated polyps (as defined by Paris Classification type Ip)
  • Suspected adenocarcinoma with deep submucosal invasion
  • Patients with ulcerated depressed lesions (as defined by Paris Classification type III) or confirmed adenocarcinoma
  • Patients with inflammatory bowel disease
  • Patients who are receiving an emergency colonoscopy
  • Poor general health (ASA class>3)
Show all 9Show fewer
  • Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
  • Inadequate bowel preparation (Boston Bowel Prep Scale, total score ≤2)
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • White River Junction VAMC

    White River Junction, Vermont, 05009

Other trials in United States

About this study

Official title: Cold Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial

This study compares different approaches to endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (≥20mm) in a 2 x 2 randomized design. The first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare EMR) and half of patient to polyp resection without electrocautery ("cold" snare EMR). The second randomization will assign half of patients to polyp removal using Eleview as the submucosal injection agent, and the other half using placebo (normal saline with methylene blue) as the submucosal injection agent.

Read the detailed description

Electrocautery, or hot snare resection has long been considered the standard approach to polyp resection. A major limitation is a 5 to 10% risk of major adverse events. Recent studies suggest that snare resection without electrocautery - so-called cold snare EMR - may be safer than hot snare EMR. The concern with cold snare resection is a potentially lower efficacy, because cold snare resection requires the removal of a large polyp in smaller and greater number of pieces than with hot snare resection. This may lengthen procedure time and increase the risk of incomplete resection.

Furthermore, there is uncertainty about the optimal injection solution for lifting of the polyp prior to resection. Normal saline with methylene blue as the contrast agent is frequently used, but is limited by fast dissipation of the polyp lift. Eleview is a newly approved viscous solution (that contains methylene blue), which provides a longer polyp lift than normal saline. It is unclear how these two solutions compare with respect to resection efficacy and safety.

Being tested
Cold snare EMR, Hot snare EMR, Eleview injection, Placebo injection
Medical subject headings
Colonic Polyps, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cold snare EMRProcedure or surgery

    Participants will have their large polyp removed without electrocautery

  • Hot snare EMRProcedure or surgery

    Participants will have their large polyp removed with electrocautery

  • Eleview injectionProcedure or surgery

    Participants will have their polyp submucosally injected with Eleview

  • Placebo injectionProcedure or surgery

    Participants will have their polyp submucosally injected with placebo

Study groups in NCT03865537
Study groupRoleWhat they receive
Cold snare & Eleview injectionExperimentalPolyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview
Receives: Procedure: Cold snare EMR; Procedure: Eleview injection
Cold Snare & Placebo injectionExperimentalPolyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo
Receives: Procedure: Cold snare EMR; Procedure: Placebo injection
Hot snare & Eleview injectionActive comparatorPolyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview
Receives: Procedure: Hot snare EMR; Procedure: Eleview injection
Hot snare & Placebo injectionActive comparatorPolyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo
Receives: Procedure: Hot snare EMR; Procedure: Placebo injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Severe Adverse Events

    Aggregate of all severe adverse events that occur at the time of the colonoscopy with resection of the large polyp or following the procedure

    Measured: up to 30 days following the procedure

Secondary outcomes (8)

  1. Subcategories of severe adverse events

    Bleeding, post-polypectomy syndrome, perforation, abdominal pain

    Measured: during the procedure and up to 30 days following the procedure

  2. Performance submucosal injectate

    Injection performance

    Measured: immediately following polyp resection during the colonoscopy

  3. Volume of submucosal injectate

    volume of injection

    Measured: immediately following polyp resection during the colonoscopy

  4. Efficacy of submucosal injectate

    Sidney index

    Measured: immediately following polyp resection during the colonoscopy

  5. Completeness of polyp resection

    Complete polyp removal is defined as removal of all visible polyp tissue at the end of the EMR, as assessed by the endoscopist.

    Measured: immediately following polyp resection during the colonoscopy

  6. Intraprocedural bleeding

    bleeding that requires endoscopic intervention to stop the bleeding

    Measured: at the time of polyp resection

  7. Polyp recurrence

    Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance colonoscopy following complete polyp resection

    Measured: at surveillance colonoscopies up to 5 years following the initial polyp resection

  8. Crossover from cold to hot snare

    Proportion of polyps in the cold snare group that could not be removed by cold snare and were removed by hot snare, categorized by size and morphology subtypes of polyps

    Measured: at the time of polyp resection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2019
  2. Study start1 Oct 2019
  3. Primary completion31 May 2024
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
2 x 2 randomized trial. First randomization: Among half of patients with a large polyp will be removed by electrocautery ("hot") snare resection, and the other half will have their polyp removed by snare resection without electrocautery ("cold"). Second randomization: Among half of patients the large polyp will by lifted (submucosal injection before resection) with Eleview; among the other by Placebo (Normal Saline with Methylene Blue).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
990 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03865537
Sponsor's protocol ID
119681
Acronym
LPS-II
Status last verified
Jun 2024
First submitted
3 Mar 2019
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pohl H, Rex DK, Barber J, Moyer MT, Elmunzer BJ, Rastogi A, Gordon SR, Zolotarevsky E, Levenick JM, Aslanian HR, Elatrache M, von Renteln D, Wallace MB, Brahmbhatt B, Keswani RN, Kumta NA, Pleskow DK, Smith ZL, Abu Ghanimeh MK, Simmer S, Sanaei O, Mackenzie TA, Piraka C. Cold snare endoscopic resection for large colon polyps: a randomised trial. Gut. 2025 Oct 8;74(11):1804-1813. doi: 10.1136/gutjnl-2025-335075.

    PubMed 40393701

  • Djinbachian R, von Renteln D. Thermal ablation of the resection base after endoscopic mucosal resection: a useful tool when perfect technique is not achievable. Gut. 2024 Sep 9;73(10):e19. doi: 10.1136/gutjnl-2023-331676. No abstract available.

    PubMed 38191267

Questions about this trial

What is this clinical trial studying?

A study testing Cold snare EMR, Hot snare EMR and Eleview injection in people with Colonic Polyp and Colonoscopy, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severe Adverse Events (time frame: up to 30 days following the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03865537, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024; AzTrials last refreshed its copy on 27 Oct 2026.

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