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

NCT ID: NCT03462706

Last Updated: 2023-02-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-06

Study Completion Date

2021-05-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Cancer Colon Polyp Colon Adenoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cold Snare

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

Group Type EXPERIMENTAL

Cold Snare

Intervention Type PROCEDURE

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 Snare

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

Group Type EXPERIMENTAL

Hot Snare

Intervention Type PROCEDURE

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 EMR

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

Group Type EXPERIMENTAL

Cold EMR

Intervention Type PROCEDURE

Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.)

Hot EMR

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

Group Type EXPERIMENTAL

Hot EMR

Intervention Type PROCEDURE

Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cold Snare

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

Hot Snare

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

Cold EMR

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

Hot EMR

Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

John D. Dingell VA Medical Center

FED

Sponsor Role collaborator

White River Junction Veterans Affairs Medical Center

FED

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Douglas K. Rex

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Douglas K Rex, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Indiana University

Indianapolis, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35288147 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1711062130

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cold Snare Polypectomy
NCT03501849 COMPLETED NA