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Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia: A Randomized Prospective Comparison of Snares and Injectate in the Resection of Large Sessile Colonic Polyps


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Neoplasms, Gastric Cancer

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Trial Information

Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia: A Randomized Prospective Comparison of Snares and Injectate in the Resection of Large Sessile Colonic Polyps


The primary aim of the study is to compare the efficacy, efficiency and safety of two types
of snares used in Endoscopic Mucosal Resection (EMR), a combined needle and snare unit
(ISnare, US Endoscopy) versus an oval braided snare with spiral wire (Snaremaster, Olympus).
The secondary aim is to explore whether EMR efficacy and efficiency is depended upon the
injection solution used, saline versus Gonak (a solution containing HPMC, saline, and
epinephrine) for EMR.


Inclusion Criteria:



- Sessile colorectal polyp

- laterally spreading lesions as defined by Paris Classification type II and > 1 cm or
greater

Exclusion Criteria:

- Those with ulcerated depressed lesions (Paris type III) or biopsy proven invasive
carcinoma

- Inflammatory bowel disease patients

- Coagulopathy ( INR> 1.5) that cannot be corrected

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of Two Devices used in EMR

Outcome Description:

To explore the efficacy of two devices used in EMR (iSnare® system versus Snaremaster) as measured by the "Sydney Resection Quotient" (SRQ). SRQ is defined as "lesion size in mm divided by the number of pieces to resect" .

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Timothy A Woodward, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic in Florida

Authority:

United States: Institutional Review Board

Study ID:

10-008104

NCT ID:

NCT01471756

Start Date:

October 2011

Completion Date:

August 2014

Related Keywords:

  • Neoplasms
  • Gastric Cancer
  • sessile neoplasms
  • flat neoplasms
  • gastric cancer
  • Neoplasms
  • Stomach Neoplasms

Name

Location
Mayo Clinic Jacksonville, Florida  32224