A Comparison of Eleview Versus Hetastarch as Injectate for EMR
Status:
Completed
Trial end date:
2019-01-07
Target enrollment:
Participant gender:
Summary
EMR is a technique used for the removal of flat or sessile neoplasms confined to the
superficial layers of the GI tract using a snare. Injection-assisted EMR is commonly used
during resections of larger flat lesions as it provides submucosal lift of polyps, adenomas,
other gastrointestinal mucosal lesions or early-stage cancers prior to EMR. This has been
found to minimize mechanical or electrocautery damage to the deep layers of the
gastrointestinal tract wall as the injectate provides a "safety cushion" as such between the
area to be removed and healthy mucosal tissue.
Several solutions are used today for injecting lesions including saline, hyaluronic acid, and
hydroxyethyl starch (Hetastarch). Saline solution has been found to dissipate within minutes,
which may result in a lower quality lesion lift. Hyaluronic acid provides a longer lift, but
is expensive and is not readily available in the U.S.
A new injectate known as Eleview has been developed for use in gastrointestinal endoscopic
procedures and recently approved by the FDA. This injectate boasts a cushion of excellent
height and duration through the use of an oil-in-water emulsion. However, the initial cost of
this material is quite high ($80 per 10 ml).
Hetastarch, which is the current injectate used by Dr Rex, is a safe and considerably
inexpensive solution that provides prolonged submucosal elevation and lowers procedure times.
Our study will aim to compare Eleview to Hetastarch in the hopes of finding the ideal
submucosal injectate.
This trial will focus on polyps of size ≥11 mm removed by snare EMR technique. Patients with
lesions deemed not suitable for EMR due to features suggestive of sub-mucosal invasion will
not be included.