Neoplasms

All Conditions

Symptoms and General Pathology

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Adenoma

Colonic Polyps

Respiratory Tract Infections

Polyps

Pathological Conditions, Anatomical

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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.

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

Cold 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.)

Hot Snare

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

Cold EMR

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

Hot EMR

Douglas K Rex, MD

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.

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.

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

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

De-identified data may be shared in the future upon request per PI discretion.

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 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.

John D. Dingell VA Medical Center

White River Junction Veterans Affairs Medical Center

Indiana University

Professor of Medicine

Patients were called approximately 30 days after their colonoscopy procedure.

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

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.)

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

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.)

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

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.)

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

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.)

Total

Age, Continuous

Sex: Female, Male

Black or African American

White

Other/Unknown

Race/Ethnicity, Customized

Number of Polyps

Diagnostic

Screening

Surveillance

Therapeutic

Indication

Detroit Veterans Affairs Medical Center

Site

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

Spots Global Cancer Trial Database for Quad Resection (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial