Skip to main content
OpenTrials
Completed

NCT Number: NCT01471756

Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of Care Procedure as described in ARM

Procedure

Standard of Care Procedure as described in ARM

Primary outcomes

  1. Efficacy of Two Devices used in EMR

    Time frame: 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 outcomes

  1. Compare the Use of Two Injectates

    Time frame: 1 year

    To compare the use of two injectates (saline versus HPMC mixture) with respect to efficacy as measured by the aforementioned SRQ.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • US Endoscopy

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 16, 2011
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.