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Completed

NCT Number: NCT02581254

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn Hosptial

Auburn, New South Wales, 2144, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thin Wire Snare

Device

Thick Wire Snare

Device

Primary outcomes

  1. Incomplete resection rate of diminutive polyps

    Time frame: 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

  2. Percentage of protrusions

    Time frame: 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 outcomes

  1. Measurement of the need for second excision in case of endoscopically visual residual adenoma

    Time frame: 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

  2. Post polypectomy bleeding requiring intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Official study title

Thin Wire Versus Thick Wire Snare for Cold Snare Polypectomy of Diminutive Polyps- A Randomised Controlled Trial

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Oct 20, 2015
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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