Colonic PolypsCSIEMRNCT01369316
Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps
A study testing Circumferential Submucosal Incision Resection and Endoscopic Mucosal Resection in people with Colonic Polyps, run by Professor Michael Bourke at 1 site in Australia.
Trial summary
That Circumferential Submucosal Incision Endoscopic Mucosal Resection (CSI-EMR) will be at least as safe but more effective than conventional EMR for injection assisted EMR of large laterally spreading tumour and sessile polyps of the colon. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Circumferential Submucosal Incision Resection and Endoscopic Mucosal Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Mar 2020to 9 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Can give informed consent to trial participation
- Age greater than 18
- Adenomas that have not have previously been attempted for resection (i.e. naïve lesions)
- Adenoma size greater than 20 mm
Who cannot join
- Age less than 18
- Previous resection or attempted resection of target adenoma lesion
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Resection for the Removal of Large Laterally Spreading Tumours and Sessile Polyps of the Colon
That Circumferential Submucosal Incision Endoscopic Mucosal Resection (CSI-EMR) will be at least as safe but more effective than conventional EMR for injection assisted EMR of large laterally spreading tumour and sessile polyps of the colon.
Read the detailed description
The investigators have recently developed a new, and the investigators believe safer and more effective technique for endoscopic mucosal resection (EMR). Utilising the new method the investigators make small cuts around the polyp to isolate it. Subsequently the Gelofusine solution is injected beneath the polyp and provides greater elevation. This allows us to improve the chance of removal of the entire polyp with one attempt in one piece. It is preferable to remove the polyp in one piece as it minimises the chance of leaving residual polyp tissue behind. Our team has recently completed an animal study comparing our newly developed technique to conventional EMR. The investigators have found significant improvements in our ability to completely remove the polyp in one attempt. There have also been recent studies overseas that have shown this new technique to be quite effective.
- Conditions
- Colonic Polyps
- Being tested
- Circumferential Submucosal Incision Resection, Endoscopic Mucosal Resection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumferential Submucosal Incision ResectionProcedure or surgery
The patient is randomized, if in the active arm the procedure will continue as Circumferential Submucosal Incision Endoscopic Mucosal Resection.
Endoscopic Mucosal ResectionProcedure or surgery
Patients randomised into this Intervention type will have Endoscopic Mucosal Resection performed
| Study group | Role | What they receive |
|---|---|---|
| Circumferential Submucosal Incision Resection | Experimental | Not described Receives: Procedure: Circumferential Submucosal Incision Resection |
| Endoscopic Mucosal Resection | Active comparator | Patients randomised into this arm will receive the conventional treatment Endoscopic Mucosal Resection in which the sessile lesion is injected and snared by piecemeal technique. Receives: Procedure: Endoscopic Mucosal Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study start9 Mar 2020
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Why it stopped: study abandoned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Michael Bourke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Michael Bourke, Western Sydney Local Health District
- Investigators
- Michael J Bourke, Principal investigator, Westmead Hospital - Endoscopy Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369316
- Sponsor's protocol ID
- EMR-002-CSI
- Acronym
- CSIEMR
- Status last verified
- Mar 2025
- First submitted
- 6 Jun 2011
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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
- Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Resection for the Removal of Large Laterally Spreading Tumours and Sessile Polyps of the Colon
- ClinicalTrials.gov ID
- NCT01369316
- Acronym / sponsor ID
- CSIEMR / EMR-002-CSI
- Conditions
- Colonic Polyps
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study abandoned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Professor Michael BourkeUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 8 Jun 2011 (estimated)
- 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.
That Circumferential Submucosal Incision Endoscopic Mucosal Resection (CSI-EMR) will be at least as safe but more effective than conventional EMR for injection assisted EMR of large laterally spreading tumour and sessile polyps of the colon.
Detailed description
The investigators have recently developed a new, and the investigators believe safer and more effective technique for endoscopic mucosal resection (EMR). Utilising the new method the investigators make small cuts around the polyp to isolate it. Subsequently the Gelofusine solution is injected beneath the polyp and provides greater elevation. This allows us to improve the chance of removal of the entire polyp with one attempt in one piece. It is preferable to remove the polyp in one piece as it minimises the chance of leaving residual polyp tissue behind. Our team has recently completed an animal study comparing our newly developed technique to conventional EMR. The investigators have found significant improvements in our ability to completely remove the polyp in one attempt. There have also been recent studies overseas that have shown this new technique to be quite effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circumferential Submucosal Incision Resection | Experimental | Procedure: Circumferential Submucosal Incision Resection |
| Endoscopic Mucosal Resection | Active comparator | Procedure: Endoscopic Mucosal ResectionPatients randomised into this arm will receive the conventional treatment Endoscopic Mucosal Resection in which the sessile lesion is injected and snared by piecemeal technique. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Can give informed consent to trial participation
- Age greater than 18
- Adenomas that have not have previously been attempted for resection (i.e. naïve lesions)
- Adenoma size greater than 20 mm
Key exclusion criteria (3 listed)
- Age less than 18
- Previous resection or attempted resection of target adenoma lesion
- Pregnant patients
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 |
|---|---|---|
| Circumferential Submucosal Incision ResectionThe patient is randomized, if in the active arm the procedure will continue as Circumferential Submucosal Incision Endoscopic Mucosal Resection. | Procedure or surgery | Circumferential Submucosal Incision Resection |
| Endoscopic Mucosal ResectionPatients randomised into this Intervention type will have Endoscopic Mucosal Resection performed | Procedure or surgery | Endoscopic Mucosal Resection |
Primary outcome
Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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. This study is not recruiting at the moment.
Michael J Bourke principal investigator
Westmead Hospital - Endoscopy Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circumferential Submucosal Incision Resection and Endoscopic Mucosal Resection in people with Colonic Polyps, run by Professor Michael Bourke 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 4 inclusion and 3 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: withdrawn, 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates) (time frame: 3 months). 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.