Clinical trial NCT00873054: Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy
Official title: Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Stones
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2009-04-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community patients who present to Charleston Area Medical Center (CAMC) or the private urology clinics of Drs. Tierney, Martinez or Davalos with kidney stones between 10 and 20 mm in size would be screened based on inclusion criteria for possible enrollment in the study.

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Within 3 months of enrollment
Secondary outcomes:
measure: 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.
timeFrame: Within 3 months of enrollment
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Urology Center of Charleston
state: West Virginia
Study officials:
affiliation: CAMC Medical Staff - with admitting privileges
name: Julio G. Davalos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CAMC Medical Staff - with admitting privileges
name: Frederick Martinez, M.D.
role: PRINCIPAL_INVESTIGATOR
References: