View Clinical Trial (Medical Research Study)
Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy
| City: |
|
Charleston |
| State: |
|
West Virginia |
| Zip Code: |
|
25301 |
| Conditions: |
|
Kidney Stones |
| Purpose: |
|
The investigators main hypothesis is that the stone free rate will be much higher (95%) in
patients treated with PCNL than patients treated with ESWL where stone free rate is (60%) to
determine which treatment is safe and prevent less stone recurrence.
|
| Study Summary: |
|
Extracorporeal shock wave lithotripsy is preferred for small stones less than 10 mm in size.
Percutaneous nephrolithotomy is the standard therapy used for large kidney stones greater
than 20 millimeters or stones in the lower kidney. For moderate sized kidney stone (10-20
mm),currently the options for treatment include both methods. However, no studies have
proven that one procedure is better than the other. So, we will compare both the procedures
for breaking the kidney stone. Our main outcome measures will be the stone-free status after
the procedure. Other outcome measures are assessment of morbidity associated with use of the
procedures i.e. any minor or major complications within 3 months of initial treatment.
Patient will be assessed for infection at post-operative office visits to include a basic
urinalysis only if they have systemic indicators of infection (fever, dysuria, frequency,
etc.). Pain will be monitored with the scale of 0-10 points. Also we will review of stone
density on Computerized Tomography (CT) scans and the effect this has on success of both
procedures. We hope with PCNL stone-free rates will be minimum with minimal morbidity and
ultimately improve patient care.
|
| Criteria: |
|
Inclusion Criteria:
- Patients of both sex with age greater than 18 years to 90 years
- Stone burden between 10 and 20 mm diagnosed by CT scan
- Patient must be agreeable to randomization between shock wave lithotripsy and
percutaneous stone removal
Exclusion Criteria:
- Patients with bleeding diathesis or taking anti-platelet or anti-coagulant medication
- Patients who are pregnant based on routine pre-operative pregnancy testing
- Patients with skin to stone size greater than 12 cm (measured routinely on CT scan)
- Patients with either Horseshoe kidney, transplant kidney or a solitary kidney
- Patients with ureteral calculi
- Patients with stone size of < 10 mm and > 20 mm
- Ureteropelvic junction obstruction
|
| NCT ID: |
|
NCT00873054 |
| Primary Contact: |
|
Principal Investigator
Julio G. Davalos, MD
CAMC Medical Staff - with admitting privileges
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Charleston, West Virginia 25301
United States
Samuel Deem, D.O.
Phone: 304-388-8250
Email: samuel_deem@yahoo.com
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 19, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|