Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps (HOT/COLD)

Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps. A Randomized Controlled Trial

This study aims to investigate the comparative effectiveness between polyp removal with or without electrical current. The investigators want to include 600 polyps in the trial.

It is known that polyps have the potential to develop to cancer if left in situ, but the investigators do not know the best way to remove them completely.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Adenoma; Colonic Polyps
• Intervention / Treatment: Procedure: Polypectomy

Detailed Description

In this study the investigators want to compare to widely used methods for polyp removal; hot and cold snare polypectomy. There has not been performed any big studies on this subject earlier, but current knowledge indicates that hot polypectomy (i.e. with use of electrical current) is somewhat better with regard to complete resection of polyps compared to cold polypectomy (without electrical current).

In this project the patients will be randomized to either hot or cold polypectomy. The investigators will distribute videos of how the polypectomies should be performed, and a gastroenterologist in the project group will instruct the doctors examining the patients to make sure that everyone performs polypectomy according to current guidelines.

The study is designed as a non-inferiority trial.

• Study Type: Interventional
• Enrollment (Actual): 429
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Outpatient colonoscopy
• Signed, written informed consent
• At least one flat/sessile polyp sized 4-9 mm identified during colonoscopy

Exclusion Criteria:

• Implanted cardiac electro converter
• Severe comorbidity (NYHA 3-4)
• Known coagulopathy (INR > 1,8) or resent use of any of the new oral anti-coagulant medications
• Platelet count < 100
• Resent use of clopidogrel or other non-acetylsalicylic acid platelet inhibitor (Last dose < 5 days before the procedure)
• Previous biopsy or attempt of polypectomy of the polyp considered for inclusion in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cold polypectomy; Patients in this arm will have their polyps removed by cold polypectomy, i.e. a metal sling that is closed around the basis of the polyp, and the polyp is cut off. After removal there will be taken biopsies from the resection margins, and both the polyp and the biopsies will be examined by a histopathologist to see if the polyp is removed completely.	Procedure: Polypectomy
Active Comparator: Hot polypectomy; Patients in this arm will have their polyps removed by hot polypectomy, i.e. a metal sling taht is closed around the basis of the polyp, electrical currents is applied, and the polyp is cut off. After removal there will be taken biopsies from the resection margins, and both the polyp and the biopsies will be examined by a histopathologist to see if the polyp is removed completely.	Procedure: Polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete resection rate	We want to measure the rate of polyps that are resected completely, both with biopsies from the margin and the histopathologists evaluation of the resection margins of the polyp itself.	Hopefully within 4 weeks, when the histopathologist has examined the biopsies

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	We want to register early (during the procedure) and late (within 4 weeks after the procedure) complications. Complications we will record is bleeding/blood in the stool, perforation and patient contact with health care provider	4 weeks
Factors explaining the primary outcome	Patient characteristics	During the hospital stay and up to 4 weeks.
Factors explaining the primary outcome	Doctor characteristics	During the hospital stay and up to 4 weeks
Factors explaining the primary outcome	Procedure characteristics	During the hospital stay and up to 4 weeks
Factors explaining the primary outcome	Histology of polyps, correlation between resection margins and biopsies, correlation between optical and histopathological diagnosis	During the hospital stay and up to 4 weeks

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF

Publications and helpful links

General Publications

• Pedersen IB, Rawa-Golebiewska A, Calderwood AH, Brix LD, Grode LB, Botteri E, Bugajski M, Kaminski MF, Januszewicz W, Odegaard H, Kleist B, Kalager M, Loberg M, Bretthauer M, Hoff G, Medhus A, Holme O. Complete polyp resection with cold snare versus hot snare polypectomy for polyps of 4-9 mm: a randomized controlled trial. Endoscopy. 2022 Oct;54(10):961-969. doi: 10.1055/a-1734-7952. Epub 2022 Jan 10.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2015
• Primary Completion (Actual): May 20, 2020
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): June 29, 2015

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Intestinal Polyps; Colorectal Neoplasms; Adenoma; Polyps; Colonic Polyps
• Other Study ID Numbers: SorlandetHF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No