Clinical trial NCT05041478: Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)
Official title: Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Polyp
Colon Adenoma
Colon Cancer
Keywords: Colonoscopy
Polypectomy
Adenoma
Colorectal Cancer
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

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

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.

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)

Primary outcomes:
measure: Complete resection rate (CRR)
timeFrame: 1 day
measure: Adenoma recurrence rate (ARR)
timeFrame: 4-6 months
Secondary outcomes:
measure: Intra-procedural and post-procedural complication rates
timeFrame: 30 days
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Endoscopy Unit
state: New South Wales
Study officials:
affiliation: Westmead Hospital (WSLHD)
name: Michael Bourke, MBBS
role: PRINCIPAL_INVESTIGATOR
References: