Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

Completed

• Conditions: Kidney Stones

• Registration Number: NCT00873054
• Lead Sponsor: CAMC Health System

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-03-31
• Study First Posted: 2009-04-01
• Primary Completion: 2010-10
• Study Completion: 2011-01
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-30
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Within 3 months of enrollment

Secondary Outcome Measures

Name	Time	Method
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.	Within 3 months of enrollment

Trial Locations

Locations (1)

Urology Center of Charleston; 🇺🇸 Charleston, West Virginia, United States