Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

C

CAMC Health System

Status

Completed

Conditions

Kidney Stones

Study type

Observational

Funder types

Other

Identifiers

NCT00873054
08-08-2078

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

32 participants in 2 patient groups

1 ESWL
Description:
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
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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