Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Gastric Cancer; Neoplasms

Treatments: Procedure: Standard of Care Procedure as described in ARM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01471756

10-008104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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66 participants in 4 patient groups

iSnare with Gonak solution

Experimental group

Treatment:

Procedure: Standard of Care Procedure as described in ARM

Snaremaster braided snare with Gonak solution

Experimental group

Treatment:

Procedure: Standard of Care Procedure as described in ARM

iSnare with saline solution

Experimental group

Treatment:

Procedure: Standard of Care Procedure as described in ARM

Snaremaster braided snare with saline solution

Experimental group

Treatment:

Procedure: Standard of Care Procedure as described in ARM