Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samuel Deem, DO, CAMC Health System
ClinicalTrials.gov Identifier:
NCT00873054
First received: March 31, 2009
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition
Kidney Stones

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

Resource links provided by NLM:


Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • 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. [ Time Frame: Within 3 months of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Within 3 months of enrollment ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: October 2008
Study Completion Date: January 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873054

Locations
United States, West Virginia
Urology Center of Charleston
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Samuel Deem, DO, Principal Investigator, CAMC Health System
ClinicalTrials.gov Identifier: NCT00873054     History of Changes
Other Study ID Numbers: 08-08-2078
Study First Received: March 31, 2009
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014