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

NCT05041478 | Recruiting DMC

• 1 other identifier: ETH11029
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Polyp; Colon Adenoma; Colon Cancer

Keywords

Colonoscopy; Polypectomy; Adenoma; Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Intra-procedural and post-procedural complication rates

  30 days

Study Arms (2)

Cold EMR with adjuvant STSC to margins

EXPERIMENTAL

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

Cold EMR

ACTIVE COMPARATOR

Standard Cold EMR resection technique

Procedure: Cold Snare Endoscopic Mucosal Resection

Interventions

Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation 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 with adjuvant STSC to margins

Cold Snare Endoscopic Mucosal Resection PROCEDURE

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

Cold EMR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Study Sites (1)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Adenoma; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Rectal Diseases

Study Officials

• Michael Bourke, MBBS

  Westmead Hospital (WSLHD)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Bourke, MBBS

CONTACT

88905555; michael@citywestgastro.com.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 13, 2021
• Study Start: September 19, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

AU (1)