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

RECRUITING

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.

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Study details:

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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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-09-19

Primary completion: 2028-10-01

Study completion finish: 2028-10-01

Study type

TREATMENT

Phase

Trial ID

NCT05041478

Intervention or treatment

PROCEDURE: Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation

PROCEDURE: Cold Snare Endoscopic Mucosal Resection

Conditions

• Colon Cancer
• Colorectal Polyp
• Colon Adenoma

Condition: Colon Cancer, Colorectal Polyp and more
PROCEDURE: Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation and other drugs
Westmead, New South Wales, Australia
Sponsor: Western Sydney Local Health District

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Find a site

Closest Location:

Westmead Endoscopy Unit

Research sites nearby

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Westmead Endoscopy Unit
Westmead, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Complete resection rate (CRR)	Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin)	1 day
Adenoma recurrence rate (ARR)	ARR at first surveillance colonoscopy (SC1) as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies)	4-6 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Intra-procedural and post-procedural complication rates	Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome	30 days

Frequently Asked Questions

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References

Clinical Trials Gov: Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)