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


N/A
18 Years
95 Years
Open (Enrolling)
Both
Colonic Polyps

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Michael J Bourke

Investigator Role:

Principal Investigator

Investigator Affiliation:

Westmead Hospital - Endoscopy Unit

Authority:

Australia: Human Research Ethics Committee

Study ID:

EMR-002-CSI

NCT ID:

NCT01369316

Start Date:

June 2011

Completion Date:

June 2016

Related Keywords:

  • Colonic Polyps
  • Colonic Polyps
  • Polyps

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