Colon PolypCARDINALNCT06462521
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
A study testing Cold Snare Piecemeal Resection (CSPR) and Cold Snare Endoscopic Mucosal Resection (Cold EMR) in people with Colon Polyp and Colon Adenoma, run by Indiana University at 9 sites in 2 countries.
Trial summary
The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Polyp, Colon Adenoma, Serrated Polyp
- What is being tested?
- Cold Snare Piecemeal Resection (CSPR) and Cold Snare Endoscopic Mucosal Resection (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
- 570 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 6 Sep 2024to Jul 2028
- 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
- ≥ 18 years of age
- Presenting for a screening, surveillance, diagnostic, or therapeutic colonoscopy
- Found to have:
- a sessile serrated lesion or hyperplastic polyp ≥ 10 mm during procedure (Serrated Cohort) or
- a 10-19 mm conventional adenoma during procedure (Adenoma Cohort)
- Ability to provide informed consent
Who cannot join
- Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- Polyps confirmed to be anything other than:
- sessile serrated lesion or hyperplastic polyp on histologic diagnosis (Serrated Cohort) or
- conventional adenoma on histologic diagnosis (Adenoma Cohort)
- Patients with Ulcerative Colitis or Crohn's disease
- Polyps with features suggestive of submucosal invasion
Show all 14Show fewer
- Polyps that are not able to be removed endoscopically due to location (e.g. extending into appendiceal orifice or diverticulum)
- Patients with a known or suspected diagnosis of any of the following polyposis syndromes with known genetic mutations:
- Familial Adenomatous Polyposis Syndrome
- MUTYH associated Polyposis Syndrome
- Juvenile Polyposis Syndrome
- Cowden's Syndrome
- Peutz-Jeghers Syndrome
- Subjects whose colonoscopy procedure is not able to be completed due to bowel prep precluding polyp identification.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States7 sites
University of Colorado
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Rush University
Chicago, Illinois, 60612
John D. Dingell VA Medical Center
Detroit, Michigan, 48201
IU Health University Hospital
Indianapolis, Indiana, 46202
The University of Kansas Medical Center
Kansas City, Kansas, 66221
White River Junction VA Medical Center
White River Junction, Vermont, 05009
Canada2 sites
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection: A RandomizeD Trial IN Colorectal Adenomas 10-19mm and Serrated Lesions ≥ 10mm (CARDINAL Study)
The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.
- Conditions
- Colon Polyp, Colon Adenoma, Serrated Polyp
- Being tested
- Cold Snare Piecemeal Resection (CSPR), Cold Snare Endoscopic Mucosal Resection (Cold EMR)
- Keywords
- Polyp Resection, Cold Snare, Cold Endoscopic Mucosal Resection (Cold EMR), Cold Snare Piecemeal Resection (CSPR), Colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Snare Piecemeal Resection (CSPR)Procedure or surgery
Qualifying polyps randomized to Cold Snare Piecemeal Resection (CSPR) will be removed using cold snare techniques (no electrocautery, no submucosal injection.)
Cold Snare Endoscopic Mucosal Resection (Cold EMR)Procedure or surgery
Qualifying polyps randomized to Cold Snare Endoscopic Mucosal Resection (Cold EMR) will be removed using cold snare techniques (no electrocautery, with submucosal injection.)
| Study group | Role | What they receive |
|---|---|---|
| Cold Snare Piecemeal Resection (CSPR) | Experimental | Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using CSPR technique. Receives: Procedure: Cold Snare Piecemeal Resection (CSPR) |
| Cold Snare Endoscopic Mucosal Resection (Cold EMR) | Experimental | Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using Cold EMR technique. Receives: Procedure: Cold Snare Endoscopic Mucosal Resection (Cold 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 or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.
Measured: 1 day
Efficacy of Resection (Peripheral Post-Resection Biopsies)
Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.
Measured: 1 day
Secondary outcomes (5)
Polyp Resection Time
The time it takes to remove the polyp completely
Measured: 1 day
Resection Preparation Time
The time it takes to prepare for polyp removal
Measured: 1 day
Total Procedure Time
The total time it takes to complete the colonoscopy procedure
Measured: 1 day
Adverse Events
The number of complications for each randomization arm during and after the procedure
Measured: 30 Days
Rate of Recurrence at First Surveillance Colonoscopy for Polyps ≥ 20mm
The recurrence rate of serrated lesions ≥ 20mm measured at the first follow-up colonoscopy
Measured: At first surveillance colonoscopy, typically 6 months to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start6 Sep 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colon PolypStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John J. Guardiola, Indiana University
- Investigators
- John J Guardiola, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462521
- Sponsor's protocol ID
- 20831
- Acronym
- CARDINAL
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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
Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1095-1129. doi: 10.1053/j.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available.
PubMed 32122632von Renteln D, Djinbachian R, Benard F, Barkun AN, Bouin M, Bouchard S, Deslandres E, Panzini B, Sidani S, Leduc R, Jobse BC, Pohl H. Incomplete resection of colorectal polyps of 4-20 mm in size when using a cold snare, and its associated factors. Endoscopy. 2023 Oct;55(10):929-937. doi: 10.1055/a-1978-3277. Epub 2022 Nov 14.
PubMed 36377124McWhinney CD, Vemulapalli KC, El Rahyel A, Abdullah N, Rex DK. Adverse events and residual lesion rate after cold endoscopic mucosal resection of serrated lesions >/=10 mm. Gastrointest Endosc. 2021 Mar;93(3):654-659. doi: 10.1016/j.gie.2020.08.032. Epub 2020 Sep 3.
PubMed 32891621Rex 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 35288147Kimoto Y, Sakai E, Inamoto R, Kurebayashi M, Takayanagi S, Hirata T, Suzuki Y, Ishii R, Konishi T, Kanda K, Negishi R, Takita M, Ono K, Minato Y, Muramoto T, Ohata K. Safety and Efficacy of Cold Snare Polypectomy Without Submucosal Injection for Large Sessile Serrated Lesions: A Prospective Study. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e132-e138. doi: 10.1016/j.cgh.2020.10.053. Epub 2020 Nov 2.
PubMed 33152541Mangira D, Raftopoulos S, Vogrin S, Hartley I, Mack A, Gazelakis K, Nalankilli K, Trinh A, Metz AJ, Appleyard M, Grimpen F, Elliott T, Brown G, Moss A. Effectiveness and safety of cold snare polypectomy and cold endoscopic mucosal resection for nonpedunculated colorectal polyps of 10-19 mm: a multicenter observational cohort study. Endoscopy. 2023 Jul;55(7):627-635. doi: 10.1055/a-2029-9539. Epub 2023 Feb 7.
PubMed 36750222Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.
PubMed 32044092
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection: A RandomizeD Trial IN Colorectal Adenomas 10-19mm and Serrated Lesions ≥ 10mm (CARDINAL Study)
- ClinicalTrials.gov ID
- NCT06462521
- Acronym / sponsor ID
- CARDINAL / 20831
- Conditions
- Colon Polyp, Colon Adenoma, Serrated Polyp
- Keywords
- Polyp Resection, Cold Snare, Cold Endoscopic Mucosal Resection (Cold EMR), Cold Snare Piecemeal Resection (CSPR), Colonoscopy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold Snare Piecemeal Resection (CSPR) | Experimental | Procedure: Cold Snare Piecemeal Resection (CSPR)Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using CSPR technique. |
| Cold Snare Endoscopic Mucosal Resection (Cold EMR) | Experimental | Procedure: Cold Snare Endoscopic Mucosal Resection (Cold EMR)Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using Cold EMR technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age
- Presenting for a screening, surveillance, diagnostic, or therapeutic colonoscopy
- Found to have:
- Ability to provide informed consent
Key exclusion criteria (14 listed)
- Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- Polyps confirmed to be anything other than:
- Patients with Ulcerative Colitis or Crohn's disease
- Polyps with features suggestive of submucosal invasion
- Polyps that are not able to be removed endoscopically due to location (e.g. extending into appendiceal orifice or diverticulum)
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 Snare Piecemeal Resection (CSPR)Qualifying polyps randomized to Cold Snare Piecemeal Resection (CSPR) will be removed using cold snare techniques (no electrocautery, no submucosal injection.) | Procedure or surgery | Cold Snare Piecemeal Resection (CSPR) |
| Cold Snare Endoscopic Mucosal Resection (Cold EMR)Qualifying polyps randomized to Cold Snare Endoscopic Mucosal Resection (Cold EMR) will be removed using cold snare techniques (no electrocautery, with submucosal injection.) | Procedure or surgery | Cold Snare Endoscopic Mucosal Resection (Cold EMR) |
Primary outcome
Efficacy of Resection (Central Post-Resection Biopsies)
Time frame: 1 day
Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.
Efficacy of Resection (Peripheral Post-Resection Biopsies)
Time frame: 1 day
Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.
5 secondary outcomes
Polyp Resection Time
Time frame: 1 day
Resection Preparation Time
Time frame: 1 day
Total Procedure Time
Time frame: 1 day
Adverse Events
Time frame: 30 Days
Rate of Recurrence at First Surveillance Colonoscopy for Polyps ≥ 20mm
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 32122632Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1095-1129. doi: 10.1053/j.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available.
- Background: PubMed 36377124von Renteln D, Djinbachian R, Benard F, Barkun AN, Bouin M, Bouchard S, Deslandres E, Panzini B, Sidani S, Leduc R, Jobse BC, Pohl H. Incomplete resection of colorectal polyps of 4-20 mm in size when using a cold snare, and its associated factors. Endoscopy. 2023 Oct;55(10):929-937. doi: 10.1055/a-1978-3277. Epub 2022 Nov 14.
- Results publication: PubMed 32891621McWhinney CD, Vemulapalli KC, El Rahyel A, Abdullah N, Rex DK. Adverse events and residual lesion rate after cold endoscopic mucosal resection of serrated lesions >/=10 mm. Gastrointest Endosc. 2021 Mar;93(3):654-659. doi: 10.1016/j.gie.2020.08.032. Epub 2020 Sep 3.
- Results publication: 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.
- Results publication: PubMed 33152541Kimoto Y, Sakai E, Inamoto R, Kurebayashi M, Takayanagi S, Hirata T, Suzuki Y, Ishii R, Konishi T, Kanda K, Negishi R, Takita M, Ono K, Minato Y, Muramoto T, Ohata K. Safety and Efficacy of Cold Snare Polypectomy Without Submucosal Injection for Large Sessile Serrated Lesions: A Prospective Study. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e132-e138. doi: 10.1016/j.cgh.2020.10.053. Epub 2020 Nov 2.
- Results publication: PubMed 36750222Mangira D, Raftopoulos S, Vogrin S, Hartley I, Mack A, Gazelakis K, Nalankilli K, Trinh A, Metz AJ, Appleyard M, Grimpen F, Elliott T, Brown G, Moss A. Effectiveness and safety of cold snare polypectomy and cold endoscopic mucosal resection for nonpedunculated colorectal polyps of 10-19 mm: a multicenter observational cohort study. Endoscopy. 2023 Jul;55(7):627-635. doi: 10.1055/a-2029-9539. Epub 2023 Feb 7.
- Results publication: PubMed 32044092Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.
- 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.
John J Guardiola, MD principal investigator
Indiana University
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Snare Piecemeal Resection (CSPR) and Cold Snare Endoscopic Mucosal Resection (Cold EMR) in people with Colon Polyp and Colon Adenoma, run by Indiana University at 9 sites in 2 countries.
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 6 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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?
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 NCT06462521, which also lists 7 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 Oct 2026.