Thin Wire Versus Thick Wire Snare for Cold Snare Polypectomy of Diminutive Polyps

Not Applicable

Completed

• Conditions: Polyps
• Interventions: Device: Thin Wire Snare; Device: Thick Wire Snare

• Registration Number: NCT02581254
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

Cold snare polypectomy (CSP) is now common practice and has proven to be a safe and effective technique for removal of diminutive polyps. Both thick and thin wire snares are now commonly used for CSP. However, because of their physical characteristics, thick wire snares might leave a higher percentage of residual adenoma at the resection site. Since this may result in a higher risk of recurrence, the technique needs to be optimized. Experts have suggested that a thin wire snare might be more efficient, with a lower risk of residual adenoma at the resection site and consequently a lower risk of recurrence and interval cancer.

Detailed Description

Approximately 90% of polyps are smaller than 10 mm. Given the risk of transformation of adenomas into invasive cancer over years, it is important that these adenomas are completely resected.

This will be a double-blind, prospective, randomized controlled trial. All eligible patients referred for a colonoscopy will be able to participate. There will be 2 treatment arms, one arm will be treated with a thin wire snare and the other with a thick wire snare. Patients will be randomised through a computer generated programme and blinded for the type of snare used. The treatment arm will be disclosed to the proceduralist after introduction of the colonoscope into the rectum. After resection of the polyp the defect will be carefully examined by the proceduralist. In case of suspicion of residual adenomatous tissue, a re-excision will be performed. If there's a protrusion noticeable at the resection site, this will be biopsied. Ultimately, the margins of the defect will be biopsied on either side for histological confirmation of complete removal.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-18
• Study First Posted: 2015-10-20
• Primary Completion: 2020-01
• Study Completion: 2021-07
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

• Patients able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
• Patients referred to Auburn Hospital Endoscopy Unit for a colonoscopy for whatever reason
• At least 1 lesion <10mm beyond the rectosigmoid junction without any endoscopic features of malignancy
• At least 1 lesion <10mm beyond the rectosigmoid junction that according to the proceduralist, can be safely removed with CSP

Exclusion Criteria

• Current use of antiplatelets (excluding aspirin) or anticoagulants which have not appropriately been interrupted
• Known coagulopathy
• Pregnancy
• If any doubt about the benign character of the polyp, the patient will be excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thin Wire Snare Arm	Thin Wire Snare	Use of Thin Wire Snare to resect polyp \<10mm
Thick Wire Snare Arm	Thick Wire Snare	Use of Thick Wire Snare to resect polyp \<10mm

Primary Outcome Measures

Name	Time	Method
Incomplete resection rate of diminutive polyps	1 year	biopsies of the margin are analysed histologically and if any adenoma is found on biopsy, this means the resection with the cold snare was incomplete
Percentage of protrusions	1 year	cold snare polypectomy can leave a protrusion in the defect, which has previously been shown to be bunched up submucosa. We will record after every polypectomy if a protrusion was visible and if it depends on the snare whether a protrusion occurs or not

Secondary Outcome Measures

Name	Time	Method
Post polypectomy bleeding requiring intervention	1 year	We will record if there is any rectal bleeding after the colonoscopy and if this required re-intervention to stop the bleeding. We will record if this was more prevalent with 1 snare type.
Measurement of the need for second excision in case of endoscopically visual residual adenoma	1 year	If there is visible adenoma left after excision, then it is in the patient's best interest that this is resected at the time of the colonoscopy. We record in which cases this was necessary and if it occurred more often with 1 snare type than the other

Trial Locations

Locations (1)

Auburn Hosptial; 🇦🇺 Auburn, New South Wales, Australia