Colorectal PolypNCT05041478
Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)
A study testing Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation and Cold Snare Endoscopic Mucosal Resection in people with Colorectal Polyp and Colon Adenoma, run by Western Sydney Local Health District at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Polyp, Colon Adenoma, Colon Cancer
- What is being tested?
- Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation and Cold Snare Endoscopic Mucosal Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Sep 2023to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Westmead Endoscopy Unit
Westmead, New South Wales, 2145
Clarence Kerrison, MBBS, 88905555, clarence.kerrison@health.nsw.gov.au
About this study
Official title: Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial
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
Read the 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
- Being tested
- Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation, Cold Snare Endoscopic Mucosal Resection
- Keywords
- Colonoscopy, Polypectomy, Adenoma, Colorectal Cancer
- Medical subject headings
- Colonic Neoplasms, Adenoma, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulationProcedure or surgery
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 Snare Endoscopic Mucosal ResectionProcedure or surgery
Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare.
| Study group | Role | What they receive |
|---|---|---|
| Cold EMR with adjuvant STSC to margins | Experimental | Standard cold EMR technique with adjuvant snare tip soft coagulation to defect margins Receives: Procedure: Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation |
| Cold EMR | Active comparator | Standard Cold EMR resection technique Receives: Procedure: Cold Snare Endoscopic Mucosal Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection rate (CRR)
Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin)
Measured: 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)
Measured: 4-6 months
Secondary outcomes (1)
Intra-procedural and post-procedural complication rates
Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start19 Sep 2023
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Michael Bourke, Western Sydney Local Health District
- Investigators
- Michael Bourke, MBBS, Principal investigator, Westmead Hospital (WSLHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041478
- Sponsor's protocol ID
- ETH11029
- Status last verified
- Mar 2025
- First submitted
- 2 Sep 2021
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05041478
- Acronym / sponsor ID
- ETH11029
- Conditions
- Colorectal Polyp, Colon Adenoma, Colon Cancer
- Keywords
- Colonoscopy, Polypectomy, Adenoma, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Cold EMR with adjuvant STSC to margins | Experimental | Procedure: Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulationStandard cold EMR technique with adjuvant snare tip soft coagulation to defect margins |
| Cold EMR | Active comparator | Procedure: Cold Snare Endoscopic Mucosal ResectionStandard Cold EMR resection technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulationUse 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. | Procedure or surgery | Cold EMR with adjuvant STSC to margins |
| Cold Snare Endoscopic Mucosal ResectionUse of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare. | Procedure or surgery | Cold EMR |
Primary outcome
Complete resection rate (CRR)
Time frame: 1 day
Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin)
Adenoma recurrence rate (ARR)
Time frame: 4-6 months
ARR at first surveillance colonoscopy (SC1) as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies)
1 secondary outcome
Intra-procedural and post-procedural complication rates
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Bourke, MBBS principal investigator
Westmead Hospital (WSLHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation and Cold Snare Endoscopic Mucosal Resection in people with Colorectal Polyp and Colon Adenoma, run by Western Sydney Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Bourke, MBBS (88905555, michael@citywestgastro.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resection rate (CRR) (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.