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NCT Number: NCT05041478

Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)

Randomised controlled trial comparing cold snare endoscopic mucosal resection (EMR) with cold snare EMR and adjuvant margin STSC in the complete resection of 15-40mm lateral-spreading adenomas

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Key information

Conditions

Colorectal Polyp Adenoma Colon Adenoma Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

Location status: Recruiting

Location contact

Clarence Kerrison, MBBS

CONTACT

[email protected]

88905555

About this study

Rationale:

Conventional EMR is well-established for the resection of lateral-spreading adenomas and has been shown to be highly efficacious with adjuvant STSC. Cauterisation-related complications occur relatively frequently and while endoscopically treatable, still carry morbidity not seen in current cold snare polypectomy data.

Cold snare polypectomy has an excellent safety profile for smaller polyps, without cauterisation-related adverse events. Limited data on cold EMR for large adenomatous laterally-spreading lesions shows minimal complications. Efficacy, however, is yet to be evaluated in prospective randomised trials. Observational data demonstrates recurrence rates exceeding conventional EMR. Since STSC causes significant reduction in recurrence in conventional EMR, the safety and efficacy of this adjuvant technique, when compared to isolated cold snare EMR, has theoretical advantages in both safety and efficacy.

The safety and efficacy of these two techniques will therefore be compared in a randomised controlled trial.

Hypothesis:

Cold snare EMR of 15-40mm lateral-spreading adenomas with adjuvant STSC is expected to be superior regarding complete resection and adenoma recurrence rates as compared to cold snare EMR.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any patient undergoing colonoscopy who is older than 18 years of age, has a written consent for trial participation and has at least one laterally spreading lesion meeting the following description:
  • Localisation in the colon or rectum
  • Benign adenomatous surface features (Kudo III / IV, Japan NBI Expert Team (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

Exclusion criteria

  • 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 colorectal cancer
  • Lesions involving the ileocaecal valve (ICV), appendiceal oriface or anorectal junction (ARJ)

Treatment and study plan

Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation

Procedure

Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare. Following this defect margins are treated with electrocautery to create a rim of ablated tissue.

Cold Snare Endoscopic Mucosal Resection

Procedure

Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare.

Primary outcomes

  1. Complete resection rate (CRR)

    Time frame: 1 day

    Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin)

  2. Adenoma recurrence rate (ARR)

    Time frame: 4-6 months

    ARR at first surveillance colonoscopy (SC1) as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies)

Secondary outcomes

  1. Intra-procedural and post-procedural complication rates

    Time frame: 30 days

    Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Bourke, MBBS

CONTACT

[email protected]

88905555

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Official study title

Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 13, 2021
Registry last updated
Mar 27, 2025

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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