Nephrolithiasis Clinical Trial
Official title:
Ureteroscopic Treatment of Intrarenal Stones - A Comparative Analysis of "Dusting" Versus "Basketing" With Holmium Laser Lithotripsy
The purpose of this study is to evaluate outcomes of an established procedure for treatment
of kidney stones that are present within the inner aspect of the kidney. This procedure is
called flexible ureteroscopy, which involves placing a small camera through the urethra while
anesthetized (asleep), up the ureter (the tube connecting kidney and bladder) and into the
kidney to the kidney stone. Then, the stone is broken into tiny fragments using a small laser
called a Holmium laser. While this treatment is a well-established option for treatment of
these stones, there are several different techniques used to help eliminate them from the
kidney. Some urologists treat the stone by a method called "active" extraction whereby the
ureteroscope is passed back and forth into the kidney to remove all visible stone fragments.
Others use a method called "dusting" whereby the stones are broken into tiny fragments or
"dust" with the intention that achieving such a small stone size will allow the stones to
pass spontaneously. There has not been a systematic and rigorous comparison of these
techniques in terms of treatment outcomes. By collecting information on the success of
treatment, the investigators hope to provide benchmark data for future studies of kidney
stone treatment and improve the care of all patients who need surgery for their kidney
stones.
The investigators hypothesize that the stone free rate for renal stone(s) 5-15 mm is around
90% and that the stone clearance rate with be 20% higher in those patients that undergo
complete stone fragment extraction versus those that undergo stone dusting (residual
fragments < 2mm).
To date, there is inadequate literature to confidently determine the ideal technique of stone
extraction during ureteroscopy, an endourologic procedure for the treatment of kidney stones.
The goals of ureteroscopy for intrarenal stones are to fragment stones and minimize residual
fragments while doing so in a safe and expeditious way with minimal harm to the patient.
Options for the treatment of intrarenal stones consist of using a basket to pull them out or
a laser to break them into small fragments. When stones are deemed too large to be basketed
primarily, the standard preference in ureteroscopic laser lithotripsy is use of the
Holmium:YAG laser which can effectively break stones into fragments small enough to remove or
pass spontaneously.
There is no consensus on how to achieve optimal stone clearance once the primary stone is
fragmented with lithotripsy. Many urologists choose to "dust" the stone by breaking
it into tiny fragments < 1 - 2 mm in size with the assumption that stone fragments of such
a small size will pass spontaneously after surgery. This can theoretically decrease operative
times and lower risk of ureteral trauma by minimizing repetitive introduction and removal of
the ureteroscope. Others choose to actively extract each possible stone fragment during the
procedure thereby increasing the immediate stone-free outcome.
Active extraction however typically increases costs as it requires use of a basket or grasper
and ureteral access sheath. To date, only one prospective, randomized study has addressed the
practice of active extraction vs spontaneous passage, the results of which suggested higher
rates of residual stone fragments, hospital readmissions and need for ancillary procedures
when stones were not actively extracted (8). This study was criticized for not following a
standardized operative protocol and not reporting several important outcomes including stone
composition. Additionally, this study used semirigid ureteroscopy, specifically addressed
ureteral rather than intrarenal stones, and did not follow a "dusting" protocol assuring
minimal size of residual fragments.
Complete eradication of stone fragments is one of the primary outcomes of ureteroscopy as
residual renal stone fragments after ureteroscopy have been shown to lead to a subsequent
stone event in approximately 20% of cases(9). However, maximizing eradication of stone
fragments must not come at the expense of the patient. For this reason it is important to
consider the operative variables associated with the different techniques employed to clear
stone during such procedures.
For example, an average of nearly three times as much laser energy was used to fragment the
stone into tiny pieces compared to active extraction (8). Conversely, active extraction of
stone fragments requires introducing and removing the ureteroscope through the ureter a
greater number of times in order to facilitate stone removal; which generally requires use of
a ureteral access sheath, a treatment with its own associated risk.(10). The short term and
long term differences resulting from use of these techniques is currently unknown.
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