Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

Kidney Stones Clinical Trial

Official title:

Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873054
• Other study ID #: 08-08-2078
• Status: Completed
• Phase: N/A
• First received: March 31, 2009
• Last updated: January 30, 2014
• Start date: October 2008
• Est. completion date: January 2011

Study information

• Verified date: January 2014
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stones
• Nephrolithiasis

Locations

Country	Name	City	State
United States	Urology Center of Charleston	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No