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

NCT ID: NCT05041478

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-19
• Study Completion Date: 2028-10-01

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.

Conditions

Colorectal Polyp; Colon Adenoma; Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cold EMR with adjuvant STSC to margins

Standard cold EMR technique with adjuvant snare tip soft coagulation to defect margins

Group Type: EXPERIMENTAL

Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation

Intervention Type: PROCEDURE

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.

Cold EMR

Standard Cold EMR resection technique

Group Type: ACTIVE_COMPARATOR

Cold Snare Endoscopic Mucosal Resection

Intervention Type: PROCEDURE

Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Sydney Local Health District

OTHER

Sponsor Role: lead

Responsible Party

Professor Michael Bourke

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Bourke, MBBS

Role: PRINCIPAL_INVESTIGATOR

Westmead Hospital (WSLHD)

Locations

Westmead Endoscopy Unit

Westmead, New South Wales, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Michael Bourke, MBBS

Role: CONTACT

michael@citywestgastro.com.au

88905555

Facility Contacts

Clarence Kerrison, MBBS

Role: primary

clarence.kerrison@health.nsw.gov.au

88905555

Other Identifiers

ETH11029

Identifier Type: -

Identifier Source: org_study_id