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

Primary Purpose

Colon Cancer, Colon Polyp, Colon Adenoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cold Snare
Hot Snare
Cold EMR
Hot EMR
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Polyp Resection, Cold Snare, Hot Snare, Cold Endoscopic Mucosal Resection (EMR), Hot Endoscopic Mucosal Resection (EMR), Colonoscopy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 40 years or older
  • Ability to provide informed consent

Exclusion Criteria:

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

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cold Snare

Hot Snare

Cold EMR

Hot EMR

Arm Description

Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques.

Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques.

Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques.

Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2018
Last Updated
February 13, 2023
Sponsor
Indiana University
Collaborators
John D. Dingell VA Medical Center, White River Junction Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03462706
Brief Title
Quad Resection (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)
Official Title
A Randomized Trial Comparing the Effectiveness of Polyp Resection Treatments (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
May 14, 2021 (Actual)
Study Completion Date
May 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
John D. Dingell VA Medical Center, White River Junction Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Colon Polyp, Colon Adenoma
Keywords
Polyp Resection, Cold Snare, Hot Snare, Cold Endoscopic Mucosal Resection (EMR), Hot Endoscopic Mucosal Resection (EMR), Colonoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cold Snare
Arm Type
Experimental
Arm Description
Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques.
Arm Title
Hot Snare
Arm Type
Experimental
Arm Description
Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques.
Arm Title
Cold EMR
Arm Type
Experimental
Arm Description
Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques.
Arm Title
Hot EMR
Arm Type
Experimental
Arm Description
Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques.
Intervention Type
Procedure
Intervention Name(s)
Cold Snare
Intervention Description
Subjects randomized to Cold Snare Intervention will have any polyps sized 6mm to 15mm removed using cold snare techniques (no electrocautery, no submucosal injection.)
Intervention Type
Procedure
Intervention Name(s)
Hot Snare
Intervention Description
Subjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.)
Intervention Type
Procedure
Intervention Name(s)
Cold EMR
Intervention Description
Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.)
Intervention Type
Procedure
Intervention Name(s)
Hot EMR
Intervention Description
Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.)
Primary Outcome Measure Information:
Title
Efficacy of Resection (Central Post-Resection Biopsies)
Description
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.
Time Frame
1 day
Title
Efficacy of Resection (Peripheral Post-Resection Biopsies)
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 40 years or older Ability to provide informed consent Exclusion Criteria: Subjects with a history of Inflammatory Bowel Disease Lesions less than 6mm or greater than 15mm in largest dimension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas K Rex, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data may be shared in the future upon request per PI discretion.
Citations:
PubMed Identifier
35288147
Citation
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.
Results Reference
derived

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

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