Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)
Recruiting · NCT05041478 · Interventional (participants receive a specific treatment) · Lead sponsor: Western Sydney Local Health District
View the official record on ClinicalTrials.gov →Interventions studied
Cold Snare Endoscopic Mucosal ResectionCold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Westmead Endoscopy Unit - Westmead, New South Wales, Australia