Comparing two methods for removing large colorectal adenomas

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

This study is testing whether a new method that combines two techniques for removing large colorectal adenomas during colonoscopy works better than using just one of the techniques alone for patients with these types of growths.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Western Sydney Local Health District (other)
• Locations: 1 site (Westmead, New South Wales)
• Trial ID: NCT05041478 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized controlled trial that compares cold snare endoscopic mucosal resection (EMR) with cold snare EMR combined with margin snare tip soft coagulation (STSC) for the complete resection of 15-40mm lateral-spreading adenomas. The study aims to evaluate the safety and efficacy of these two techniques, focusing on complete resection rates and adenoma recurrence. Participants will be patients undergoing colonoscopy who have specific types of adenomas, and the trial will assess the outcomes of the different intervention methods. The hypothesis is that the combination of cold snare EMR with STSC will yield better results than cold snare EMR alone.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with specific types of laterally spreading adenomas located in the colon or rectum.

Not a fit: Patients with bleeding disorders, pregnancy, or those with certain types of lesions or concurrent colorectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved safety and efficacy in the removal of large colorectal adenomas, reducing recurrence rates.

How similar studies have performed: While conventional EMR has been well-established, this specific comparison of cold snare EMR with and without STSC is novel and has not been extensively tested in prior studies.

Eligibility 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)

Where this trial is running

Westmead, New South Wales

• Westmead Endoscopy Unit — Westmead, New South Wales, Australia (RECRUITING)

Study contacts

• Principal investigator: Michael Bourke, MBBS — Westmead Hospital (WSLHD)
• Study coordinator: Michael Bourke, MBBS

Conditions: Colorectal Polyp, Colon Adenoma, Colon Cancer, Colonoscopy, Polypectomy, Adenoma, Colorectal Cancer