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 Overview

• Status: Completed
• Conditions: Kidney Stones

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 Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • Urology center of charleston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1 ESWL; 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.
2 PCNL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: CAMC Health System
• Investigators: Principal Investigator: Julio G. Davalos, MD, CAMC Medical Staff - with admitting privileges; Principal Investigator: Frederick Martinez, M.D., CAMC Medical Staff - with admitting privileges

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: March 31, 2009
• First Submitted That Met QC Criteria: March 31, 2009
• First Posted (Estimate): April 1, 2009

Study Record Updates

• Last Update Posted (Estimate): February 3, 2014
• Last Update Submitted That Met QC Criteria: January 30, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Nephrolithiasis; Kidney Calculi
• Other Study ID Numbers: 08-08-2078