Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach
| Status: | Completed |
|---|---|
| Conditions: | Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/3/2013 |
| Start Date: | October 2011 |
| End Date: | July 2014 |
| Contact: | Levi A Deters, MD |
| Email: | levi.a.deters@hitchcock.org |
| Phone: | 603.650.6051 |
Kidney stones are very common, and can inflict a significant degree of pain and renal
damage. Some stones become obstructed in the ureter, the tube that drains the kidney. In
order to remove these stones, an Urologist and their team use fluoroscopic guidance to do
so, this involves continuous X-ray. Flouroscopy delivers a significant dose of radiation to
the patient, as well as the health care team, which has been shown to have serious health
consequences. Previous studies have shown that in certain populations, like pregnant women,
stones can be managed using ultrasound guidance. The investigators propose that mid and
distal ureteral stones could be managed using ultrasound guidance in conjunction with
conventional stone removal techniques (ureteroscopy, lithotripsy, and ureteral stent
placement), in lieu of fluoroscopy, thereby minimizing radiation to healthcare staff and
patients.
The investigators hypothesize that distal ureteral stones can be identified and efficiently
fragmented and removed under ultrasound guidance in a safe and effective manner without the
use of radiation.
Patients will be enrolled and consented for this study in our Urology Clinic at Dartmouth
Hitchcock Memorial Hospital and randomized prospectively to fluoroscopic versus ultrasound
guided groups. A computer randomization program will be used to randomize the patient to
the test or control group. Randomization will take place after they have consented to
participate in the study, and the case will be booked accordingly. Consent to participate
in this study will be obtained at the patient's followup appointment. At the time of the
initial clinical encounter they will be provided with the consent form and information
regarding the study. Once they have had the chance to look this over they will be contacted
about whether they would consent to be in the study. If so, they will be randomized and the
consent form signed on the morning of the procedure. Each group will consist of 25
patients. This pilot group size was determined based on feasibility of recruitment in the
study period and funding availability.
All patients will receive preoperative antibiotics selected in accordance to their previous
urine culture sensitivities and their respective allergies where applicable.
Intraoperatively, all patients will be placed in the dorsal lithotomy position. All
patients will be under general anesthesia, in both treatment arms, this is standard of care.
All procedures will begin with standard cystourethroscopy, removal of the previous ureteral
stent, and passage of a wire proximally into the renal pelvis. The ultrasound group will
undergo intraoperative transabdominal ultrasonography by a designated ultrasonographer, and
the presence of the wire, and later the ureteral stent, within the renal pelvis will be
confirmed via ultrasound in all patients. The control group will undergo standard
verification of wire and stent placement via fluoroscopy. Operative time as well as
radiation fluoroscopy time will be recorded and compared between the two groups. At our
institution, this procedure is scheduled for 140 minutes of OR time based on previous
experience by our group and this individual surgeon. Stone free rate will be determined at
one month post operatively with a KUB and renal ultrasound and compared between groups.
Intraoperatively, if there is concern for poor visualization, lack of progress, or technical
difficulty related to the use of intraoperative ultrasound, or any other safety concerns,
then this technique will be abandoned and conventional fluoroscopy will be used for this
patient group. This will be apparent in the first 15 - 30 minutes of the procedure.
Inclusion Criteria:
Selection criteria will include adult patients with mid and distal ureteral stones ≤8mm,
and will be stented prior to presenting for their intervention. Ureteral stenting prior
to ureteroscopy is the standard at Dartmouth Hitchcock Medical Center, and both the test
and control group will be stented for two weeks prior to their procedure. Initial
ureteral stenting will be performed using conventional fluoroscopy at the discretion of
the surgeon as this may be in the acute setting and not within the scope of this trial.
The mid and distal portion of the ureter refers to the segment of ureter that extends from
the upper portion of the sacrum distally to the bladder.
Exclusion Criteria:
Patients will be excluded from the trial if they have had surgical resection involving the
bladder or ureter, or a history of known ureteral stricture. Also, this is only for adult
patients (>18yo).
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