NCT02581254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

4.5 years

First QC Date

October 15, 2015

Last Update Submit

June 28, 2023

Conditions

Polyps

Keywords

SnarePolypectomy

Outcome Measures

Primary Outcomes (2)

  • 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

    1 year

  • 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

    1 year

Secondary Outcomes (2)

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

    1 year

  • Post polypectomy bleeding requiring intervention

    1 year

Study Arms (2)

Thin Wire Snare Arm

EXPERIMENTAL

Use of Thin Wire Snare to resect polyp \<10mm

Device: Thin Wire Snare

Thick Wire Snare Arm

EXPERIMENTAL

Use of Thick Wire Snare to resect polyp \<10mm

Device: Thick Wire Snare

Interventions

Thin Wire SnareDEVICE
Thin Wire Snare Arm
Thick Wire SnareDEVICE
Thick Wire Snare Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auburn Hosptial

Auburn, New South Wales, 2144, Australia

Location

Related Publications (1)

  • 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.

    PMID: 34817440DERIVED

MeSH Terms

Conditions

Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Dr Lee, FRACP

    Westmead Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Specialist Gastroenterology

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 20, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2020

Study Completion

July 1, 2021

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)