RecruitingNot ApplicableNCT05041478

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

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


Sponsor

Western Sydney Local Health District

Enrollment

300 participants

Start Date

Sep 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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)

Interventions

PROCEDURECold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation

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.

PROCEDURECold Snare Endoscopic Mucosal Resection

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


Locations(1)

Westmead Endoscopy Unit

Westmead, New South Wales, Australia

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NCT05041478


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