Colon CancerNCT03462706

Quad Resection (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)

A study testing Cold Snare, Hot Snare and Cold EMR in people with Colon Cancer and Colon Polyp, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will compare the use of cold snare, hot snare, cold EMR, and hot EMR for polyp resection. Although previous studies have compared two of the potential resection methods, no previous study has evaluated all four of the resection methods. Read more about this study

Who is it for?: Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for: Colon Cancer, Colon Polyp, Colon Adenoma
What is being tested?: Cold Snare, Hot Snare and Cold EMR
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 238 participants
Where: 1 siteUnited States
Study dates: 6 Feb 2018to 14 May 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged 40 years or older
Ability to provide informed consent

Who cannot join

Subjects with a history of Inflammatory Bowel Disease
Lesions less than 6mm or greater than 15mm in largest dimension

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Randomized Trial Comparing the Effectiveness of Polyp Resection Treatments (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)

Read the detailed description

The optimal method for removal of polyps 6-9 and 10-15 mm in size is not established. In this study, we propose to evaluate four different treatments for polyps (sized 6mm-15mm). The four treatments are cold snaring without injection, hot snaring without injection, cold EMR, and hot EMR. This study aims to help to establish the optimal resection technique for 6-9 and 10-15 mm polyps.

Conditions: Colon Cancer, Colon Polyp, Colon Adenoma
Being tested: Cold Snare, Hot Snare, Cold EMR, Hot EMR
Keywords: Polyp Resection, Cold Snare, Hot Snare, Cold Endoscopic Mucosal Resection (EMR), Hot Endoscopic Mucosal Resection (EMR), Colonoscopy
Medical subject headings: Colonic Neoplasms, Colonic Polyps

What participants receive

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

Cold SnareProcedure or surgery
Subjects randomized to Cold Snare Intervention will have any polyps sized 6mm to 15mm removed using cold snare techniques (no electrocautery, no submucosal injection.)
Hot SnareProcedure or surgery
Subjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.)
Cold EMRProcedure or surgery
Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.)
Hot EMRProcedure or surgery
Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.)

Study groups in NCT03462706
Study group	Role	What they receive
Cold Snare	Experimental	Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques. Receives: Procedure: Cold Snare
Hot Snare	Experimental	Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques. Receives: Procedure: Hot Snare
Cold EMR	Experimental	Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques. Receives: Procedure: Cold EMR
Hot EMR	Experimental	Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques. Receives: Procedure: Hot EMR

What is being measured

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

Efficacy of Resection (Central Post-Resection Biopsies)
Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the central post-resection biopsies. Positive means that there was residual polyp tissue seen on the central post-resection biopsies. Negative central post-resection biopsies are considered a better outcome.
Measured: 1 day
Efficacy of Resection (Peripheral Post-Resection Biopsies)
Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the peripheral post-resection biopsies. Positive means that there was residual polyp tissue seen on the peripheral post-resection biopsies. Negative peripheral post-resection biopsies are considered a better outcome.
Measured: 1 day

Timeline

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

6 Feb 201814 May 2021

First posted12 Mar 2018
Study start6 Feb 2018
Primary completion14 May 2021
Study completion14 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colon CancerStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Parallel groups
Masking: None (open label)
Enrolment: 238 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03462706
Sponsor's protocol ID: 1711062130
Status last verified: Feb 2023
First submitted: 6 Mar 2018
Last updated: 15 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: De-identified data may be shared in the future upon request per PI discretion.

Publications

Rex DK, Anderson JC, Pohl H, Lahr RE, Judd S, Antaki F, Lilley K, Castelluccio PF, Vemulapalli KC. Cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2022 Aug;96(2):330-338. doi: 10.1016/j.gie.2022.03.006. Epub 2022 Mar 12.
PubMed 35288147

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial Comparing the Effectiveness of Polyp Resection Treatments (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)
ClinicalTrials.gov ID: NCT03462706
Acronym / sponsor ID: 1711062130
Conditions: Colon Cancer, Colon Polyp, Colon Adenoma
Keywords: Polyp Resection, Cold Snare, Hot Snare, Cold Endoscopic Mucosal Resection (EMR), Hot Endoscopic Mucosal Resection (EMR), Colonoscopy
Study type: Interventional
Recruitment status: Completed
Enrolment: 238 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Collaborators: John D. Dingell VA Medical Center, White River Junction Veterans Affairs Medical Center
Study start: 6 Feb 2018 (actual)
Primary completion: 14 May 2021 (actual)
Study completion: 14 May 2021 (actual)
First posted: 12 Mar 2018 (actual)
Results: Posted 15 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cold Snare	Experimental	Procedure: Cold SnarePolyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques.
Hot Snare	Experimental	Procedure: Hot SnarePolyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques.
Cold EMR	Experimental	Procedure: Cold EMRPolyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques.
Hot EMR	Experimental	Procedure: Hot EMRPolyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Aged 40 years or older
Ability to provide informed consent

Key exclusion criteria (2 listed)

Subjects with a history of Inflammatory Bowel Disease
Lesions less than 6mm or greater than 15mm in largest dimension

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cold SnareSubjects randomized to Cold Snare Intervention will have any polyps sized 6mm to 15mm removed using cold snare techniques (no electrocautery, no submucosal injection.)	Procedure or surgery	Cold Snare
Hot SnareSubjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.)	Procedure or surgery	Hot Snare
Cold EMRSubjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.)	Procedure or surgery	Cold EMR
Hot EMRSubjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.)	Procedure or surgery	Hot EMR

Primary outcome

Efficacy of Resection (Central Post-Resection Biopsies)
Time frame: 1 day
Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the central post-resection biopsies. Positive means that there was residual polyp tissue seen on the central post-resection biopsies. Negative central post-resection biopsies are considered a better outcome.
Efficacy of Resection (Peripheral Post-Resection Biopsies)
Time frame: 1 day
Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the peripheral post-resection biopsies. Positive means that there was residual polyp tissue seen on the peripheral post-resection biopsies. Negative peripheral post-resection biopsies are considered a better outcome.

Results and safety

Results posted to the registry on 15 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cold Snare	60	59
Cold EMR	63	63
Hot Snare	58	57
Hot EMR	57	56

Primary outcome: Efficacy of Resection (Central Post-Resection Biopsies)

Time frame: 1 day. Count of units. Unit: Polyps

Measure	Cold Snare n = 59	Cold EMR n = 63	Hot Snare n = 57	Hot EMR n = 56
Negative	68	82	69	63
Positive	0	0	2	2

Primary outcome: Efficacy of Resection (Peripheral Post-Resection Biopsies)

Time frame: 1 day. Count of units. Unit: Polyps

Measure	Cold Snare n = 59	Cold EMR n = 63	Hot Snare n = 57	Hot EMR n = 56
Negative	68	81	70	62
Positive	0	1	1	3

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cold Snare	0 of 59 (0%)	8 of 59 (13.6%)	0 of 59
Cold EMR	0 of 63 (0%)	11 of 63 (17.5%)	0 of 63
Hot Snare	1 of 57 (1.8%)	10 of 57 (17.5%)	0 of 57
Hot EMR	1 of 56 (1.8%)	6 of 56 (10.7%)	0 of 56

Limitations and caveats (from the sponsor): Study endoscopists are experts with special interest in polypectomy; serrated lesions were included in the study instead of only including adenomas; incomplete resections occurred in 10-15mm lesions so a study designed for 10-15mm or 10-20mm lesions may be more relevant; potential of proceduralist bias due to lack of endoscopist blinding; relying on biopsies of the defect instead of evaluation of scars at surveillance for determining efficacy

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35288147Rex DK, Anderson JC, Pohl H, Lahr RE, Judd S, Antaki F, Lilley K, Castelluccio PF, Vemulapalli KC. Cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2022 Aug;96(2):330-338. doi: 10.1016/j.gie.2022.03.006. Epub 2022 Mar 12.
Individual participant dataSharing planned: No. De-identified data may be shared in the future upon request per PI discretion.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Douglas K Rex, MD principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cold Snare, Hot Snare and Cold EMR in people with Colon Cancer and Colon Polyp, run by Indiana University 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 2 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: finished, as of the sponsor's last update on 15 Feb 2023. 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?

Yes. Results are posted in the registry (first posted 15 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Efficacy of Resection (Central Post-Resection Biopsies) (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT03462706, which also lists 1 linked publication.

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 15 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.