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Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

Primary Purpose

Neoplasms, Gastric Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Standard of Care Procedure as described in ARM
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring sessile neoplasms, flat neoplasms, gastric cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

iSnare with Gonak solution

Snaremaster braided snare with Gonak solution

iSnare with saline solution

Snaremaster braided snare with saline solution

Arm Description

Outcomes

Primary Outcome Measures

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" .

Secondary Outcome Measures

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.

Full Information

First Posted
September 29, 2011
Last Updated
September 5, 2014
Sponsor
Mayo Clinic
Collaborators
US Endoscopy
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1. Study Identification

Unique Protocol Identification Number
NCT01471756
Brief Title
Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
US Endoscopy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Gastric Cancer
Keywords
sessile neoplasms, flat neoplasms, gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iSnare with Gonak solution
Arm Type
Experimental
Arm Title
Snaremaster braided snare with Gonak solution
Arm Type
Experimental
Arm Title
iSnare with saline solution
Arm Type
Experimental
Arm Title
Snaremaster braided snare with saline solution
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Standard of Care Procedure as described in ARM
Intervention Description
Standard of Care Procedure as described in ARM
Primary Outcome Measure Information:
Title
Efficacy of Two Devices used in EMR
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" .
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Compare the Use of Two Injectates
Description
To compare the use of two injectates (saline versus HPMC mixture) with respect to efficacy as measured by the aforementioned SRQ.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy A Woodward, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

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