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

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ClinicalTrials.gov Identifier: NCT05041478
Recruitment Status : Not yet recruiting
First Posted : September 13, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

Brief 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

Condition or disease Intervention/treatment Phase
Colorectal Polyp Colon Adenoma Colon Cancer Procedure: Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation Procedure: Cold Snare Endoscopic Mucosal Resection Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised Controlled Trial
Masking: Single (Outcomes Assessor)
Masking Description: Blinding
Primary Purpose: Treatment
Official Title: Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Cold EMR with adjuvant STSC to margins
Standard cold EMR technique with adjuvant snare tip soft coagulation to defect margins
Procedure: Cold 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.

Active Comparator: Cold EMR
Standard Cold EMR resection technique
Procedure: Cold 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041478


Contacts
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Contact: Kathleen Goodrick 88905555 Kathleen.goodrick@health.nsw.gov.au

Locations
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Australia, New South Wales
Westmead Endoscopy Unit
Westmead, New South Wales, Australia, 2145
Sponsors and Collaborators
Western Sydney Local Health District
Investigators
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Principal Investigator: Michael Bourke, MBBS Westmead Hospital (WSLHD)
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Responsible Party: Professor Michael Bourke, Professor, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT05041478    
Other Study ID Numbers: ETH11029
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Michael Bourke, Western Sydney Local Health District:
Colonoscopy
Polypectomy
Adenoma
Colorectal Cancer
Additional relevant MeSH terms:
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Adenoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type