Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy
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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy|
- The primary objective of this study is to compare the stone-free status after Extracorporeal Shock Wave Lithotripsy (ESWL) and Percutaneous Nephrolithotomy (PCNL) for kidney stones 10-20 mm in size. [ Time Frame: Within 3 months of enrollment ] [ Designated as safety issue: No ]
- A secondary objective is to assess the morbidity associated with use of the procedures i.e. any minor or major complications within 3 months of initial treatment. [ Time Frame: Within 3 months of enrollment ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||January 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
In this procedure,scope will be placed inside bladder and a plastic tube (stent) will be left to drain the kidney on the affected side in a routine manner. Next the patient will be transferred to a separate room and sound waves will be aimed at the center of the stone until the stone is broken into pieces.
In this procedure,scope will be placed inside bladder and a plastic tube (stent) will be left to drain the kidney on the affected side in a routine manner. Next, a small (1cm) cut will be made in the back and a tube will be placed into the kidney. Through this tube a small camera will be placed inside the kidney and break the stone into many pieces and remove them through the same tube. All fragments that can be seen will be removed. A different plastic tube (drain) will be placed through the cut and into the kidney and left in place for 5-7 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873054
|United States, West Virginia|
|Urology Center of Charleston|
|Charleston, West Virginia, United States, 25301|
|Principal Investigator:||Julio G. Davalos, MD||CAMC Medical Staff - with admitting privileges|
|Principal Investigator:||Frederick Martinez, M.D.||CAMC Medical Staff - with admitting privileges|