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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01471756

Enrollment

Registered

2011-11-16

Start date

2011-10-31

Completion date

2014-05-31

Last updated

2014-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Neoplasms

Keywords

sessile neoplasms, flat neoplasms, gastric cancer

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.

Interventions

PROCEDUREStandard of Care Procedure as described in ARM

Standard of Care Procedure as described in ARM

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026