Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps

NCT ID: NCT02484079

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 429 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-18
• Study Completion Date: 2022-12-31

Brief Summary

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.

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.

Conditions

Colonic Polyps; Colorectal Neoplasms; Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Polypectomy

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

Polypectomy

Intervention Type: PROCEDURE

Interventions

Polypectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 35008112 (View on PubMed)

Other Identifiers

SorlandetHF

Identifier Type: -

Identifier Source: org_study_id