Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

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 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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Gastric Cancer
• Intervention / Treatment: Procedure: Standard of Care Procedure as described in ARM

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iSnare with Gonak solution	Procedure: Standard of Care Procedure as described in ARM; Standard of Care Procedure as described in ARM
Experimental: Snaremaster braided snare with Gonak solution	Procedure: Standard of Care Procedure as described in ARM; Standard of Care Procedure as described in ARM
Experimental: iSnare with saline solution	Procedure: Standard of Care Procedure as described in ARM; Standard of Care Procedure as described in ARM
Experimental: Snaremaster braided snare with saline solution	Procedure: Standard of Care Procedure as described in ARM; Standard of Care Procedure as described in ARM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Two Devices used in EMR	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" .	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: US Endoscopy
• Investigators: Principal Investigator: Timothy A Woodward, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Estimate): September 8, 2014
• Last Update Submitted That Met QC Criteria: September 5, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: gastric cancer; sessile neoplasms; flat neoplasms
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Neoplasms; Stomach Neoplasms
• Other Study ID Numbers: 10-008104