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Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps

Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Resection for the Removal of Large Laterally Spreading Tumours and Sessile Polyps of the Colon

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01369316
Acronym
CSIEMR
Enrollment
0
Registered
2011-06-08
Start date
2020-03-09
Completion date
2020-03-09
Last updated
2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyps

Brief 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.

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.

Interventions

PROCEDURECircumferential Submucosal Incision Resection

The patient is randomized, if in the active arm the procedure will continue as Circumferential Submucosal Incision Endoscopic Mucosal Resection.

PROCEDUREEndoscopic Mucosal Resection

Patients randomised into this Intervention type will have Endoscopic Mucosal Resection performed

Sponsors

Professor Michael Bourke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Age less than 18 * Previous resection or attempted resection of target adenoma lesion * Pregnant patients

Design outcomes

Primary

MeasureTime frame
Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)3 months

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026