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

Primary Purpose

Polyps

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Thin Wire Snare
Thick Wire Snare
Sponsored by
Western Sydney Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polyps focused on measuring Snare, Polypectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Auburn Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Thin Wire Snare Arm

Thick Wire Snare Arm

Arm Description

Use of Thin Wire Snare to resect polyp <10mm

Use of Thick Wire Snare to resect polyp <10mm

Outcomes

Primary Outcome Measures

Incomplete resection rate of diminutive polyps
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
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

Measurement of the need for second excision in case of endoscopically visual residual adenoma
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
Post polypectomy bleeding requiring intervention
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.

Full Information

First Posted
October 15, 2015
Last Updated
June 28, 2023
Sponsor
Western Sydney Local Health District
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1. Study Identification

Unique Protocol Identification Number
NCT02581254
Brief Title
Thin Wire Versus Thick Wire Snare for Cold Snare Polypectomy of Diminutive Polyps
Official Title
Thin Wire Versus Thick Wire Snare for Cold Snare Polypectomy of Diminutive Polyps- A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
July 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Sydney Local Health District

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyps
Keywords
Snare, Polypectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thin Wire Snare Arm
Arm Type
Experimental
Arm Description
Use of Thin Wire Snare to resect polyp <10mm
Arm Title
Thick Wire Snare Arm
Arm Type
Experimental
Arm Description
Use of Thick Wire Snare to resect polyp <10mm
Intervention Type
Device
Intervention Name(s)
Thin Wire Snare
Intervention Type
Device
Intervention Name(s)
Thick Wire Snare
Primary Outcome Measure Information:
Title
Incomplete resection rate of diminutive polyps
Description
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
Time Frame
1 year
Title
Percentage of protrusions
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Measurement of the need for second excision in case of endoscopically visual residual adenoma
Description
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
Time Frame
1 year
Title
Post polypectomy bleeding requiring intervention
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Dr Lee, FRACP
Organizational Affiliation
Westmead Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auburn Hosptial
City
Auburn
State/Province
New South Wales
ZIP/Postal Code
2144
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34817440
Citation
Sidhu M, Forbes N, Tate DJ, Desomer L, Lee EYT, Burgess N, van Hattem A, Mcleod D, Cheng E, Cartwright S, Schell A, Hilsden RJ, Heitman SJ, Bourke MJ. A Randomized Controlled Trial of Cold Snare Polypectomy Technique: Technique Matters More Than Snare Wire Diameter. Am J Gastroenterol. 2022 Jan 1;117(1):100. doi: 10.14309/ajg.0000000000001554.
Results Reference
derived

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

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