Delayed Bleeding Clinical Trial
Official title:
A Randomized, Double-blind, Comparative, Effectiveness and Safety Study of Eleview vs. Hetastarch in Subjects Undergoing Endoscopic Mucosal Resection (EMR) of Colonic Lesions Equal to or Larger Than 11mm
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.
Injectate randomization:
Study patients will be randomly assigned to the Eleview or the Hetastarch treatment group in
a 1:1 ratio. Randomization will occur at the site using envelopes provided by the
Investigator. The envelope's contents will specify the treatment assignment for each patient
and opened by the research team (PI will be blinded). The investigators will monitor the
safety and effectiveness data. The appropriate solutions will be injected into the submucosal
space beneath the lesion(s) to be excised before the lesion(s) is/are removed. Subjects in
both groups will receive the appropriate volume of injectate deemed necessary by the PI for
the individual patient.
Sample size and Statistical Analysis At least 200 patients will be enrolled. 100 of these
patients will be randomized to Eleview injectate and 100 will be given the standard of care,
Hetastarch injectate only. Efficacy and safety of Eleview injectate has only been reviewed in
one previous study. Therefore, the planned sample size was not calculated using a statistical
power analysis, but was regarded as sufficient to repeat the objectives of the COSMO study
(2017) and satisfy the exploratory purposes of the present study.
Study personnel will carry out a simple randomization using a commonly used online generator.
Randomization assignments will then be sealed until day of procedure until patient
eligibility has been confirmed. The Principal Investigator will remain blinded and will
perform all data analysis after completion of the study.
Data will be summarized and compared using classic descriptive statistics, i.e. mean,
standard deviation, coefficient of variation (%), minimum, median and maximum values for
quantitative variables, and frequencies for qualitative variables.
The Sydney Resection Quotient will be compared between treatment groups using a Wilcoxon
Rank-Sum test. The proportion of subjects with en bloc resection of all endoscopically
visible lesions will also be compared between treatment groups using a Fisher's exact test. A
nominal alpha level of 0.05 will be used for both the comparisons.
No formal comparison will be performed for the secondary endpoints.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01179724 -
Comparison of Proton Pump Inhibitor and H2 Receptor Blocker on Prevention of Bleeding From Iatrogenic Ulcer After Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Controlled Trial
|
N/A |