NCT04138030

Brief Summary

Comparing the complete resection rate and subsequent adenoma recurrence rate at surveillance colonoscopy of 15-40mm laterally spreading adenomas for conventional EMR vs. cold snare EMR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

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

First Submitted

Initial submission to the registry

October 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

November 12, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2024

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

4.3 years

First QC Date

October 20, 2019

Last Update Submit

March 25, 2025

Conditions

Adenoma ColonColon AdenomaColon Cancer

Keywords

ColonoscopyPolypectomyAdenomaColorectal cancer

Outcome Measures

Primary Outcomes (2)

  • Complete resection rate

    Complete resection rate (CRR) as determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin)

    1 day

  • Adenoma recurrence rate

    Adenoma recurrence rate (ARR) at SC1 as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies)

    4-6 months

Secondary Outcomes (2)

  • Time to perform polypectomy

    1 day

  • Intra-procedural and post-procedural complications

    30 days

Study Arms (2)

Conventional Endoscopic Mucosal Resection

ACTIVE COMPARATOR

Conventional Endoscopic Mucosal Resection (EMR), if necessary, to 15-40mm laterally spreading adenomas.

Procedure: Conventional Endoscopic Mucosal Resection

Cold Snare Endoscopic Mucosal Resection

ACTIVE COMPARATOR

Cold Snare Endoscopic Mucosal Resection (EMR), if necessary, to 15-40mm laterally spreading adenomas.

Procedure: Cold Snare Endoscopic Mucosal Resection

Interventions

Conventional Endoscopic Mucosal ResectionPROCEDURE

Use of injected chromogelofusine solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery

Also known as: Conventional EMR
Conventional Endoscopic Mucosal Resection
Cold Snare Endoscopic Mucosal ResectionPROCEDURE

Use of injected chromogelofusine solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery

Also known as: CSP
Cold Snare Endoscopic Mucosal Resection

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient undergoing colonoscopy who is older than 18 years of age, has a written consent for trial participation and has at least one LSL meeting to the following description:
  • Localisation in the colon or rectum
  • Benign adenomatous surface features (Kudo III / IV, JNET 2a)
  • Granular or non-granular topography
  • Paris classification 0-IIa/IIb +/- Is
  • If present, sessile component may be no greater than 10mm in size.
  • Polyp size ranging from 15 to 40mm

You may not qualify if:

  • Current use of antiplatelet (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines.
  • Known bleeding disorder or coagulopathy.
  • Pregnancy
  • History of inflammatory bowel disease
  • Previously attempted or otherwise non-lifting lesions
  • Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3) or concurrent CRC
  • Lesions involving the ileocaecal valve (ICV) or the anorectal junction (ARJ)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

Location

Related Publications (1)

  • O'Sullivan T, Cronin O, van Hattem WA, Mandarino FV, Gauci JL, Kerrison C, Whitfield A, Gupta S, Lee E, Williams SJ, Burgess N, Bourke MJ. Cold versus hot snare endoscopic mucosal resection for large (>/=15 mm) flat non-pedunculated colorectal polyps: a randomised controlled trial. Gut. 2024 Oct 7;73(11):1823-1830. doi: 10.1136/gutjnl-2024-332807.

    PMID: 38964854DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsAdenomaColorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeRectal Diseases

Study Officials

  • Michael Bourke, MBBS

    Western SLHD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 20, 2019

First Posted

October 24, 2019

Study Start

November 12, 2019

Primary Completion

March 5, 2024

Study Completion

March 5, 2024

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

AU(1)