Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

Phase 4

Completed

• Conditions: Gastric Cancer; Neoplasms
• Interventions: Procedure: Standard of Care Procedure as described in ARM

• Registration Number: NCT01471756
• Lead Sponsor: Mayo Clinic

Brief Summary

The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-09-29
• Study Start: 2011-10
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-16
• Primary Completion: 2013-07
• Study Completion: 2014-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-05
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Sessile colorectal polyp
• laterally spreading lesions as defined by Paris Classification type II and > 1 cm or greater

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Snaremaster braided snare with Gonak solution	Standard of Care Procedure as described in ARM	-
Snaremaster braided snare with saline solution	Standard of Care Procedure as described in ARM	-
iSnare with Gonak solution	Standard of Care Procedure as described in ARM	-
iSnare with saline solution	Standard of Care Procedure as described in ARM	-

Primary Outcome Measures

Name	Time	Method
Efficacy of Two Devices used in EMR	1 year	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" .

Secondary Outcome Measures

Name	Time	Method
Compare the Use of Two Injectates	1 year	To compare the use of two injectates (saline versus HPMC mixture) with respect to efficacy as measured by the aforementioned SRQ.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States