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Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

Sponsor
CAMC Health System (Other)
Overall Status
Completed
CT.gov ID
NCT00873054
Collaborator
(none)
32
Enrollment
1
Location
27
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    32 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy
    Study Start Date :
    Oct 1, 2008
    Actual Primary Completion Date :
    Oct 1, 2010
    Actual Study Completion Date :
    Jan 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samuel Deem, DO, Principal Investigator, CAMC Health System
    ClinicalTrials.gov Identifier:
    NCT00873054
    Other Study ID Numbers:
    • 08-08-2078
    First Posted:
    Apr 1, 2009
    Last Update Posted:
    Feb 3, 2014
    Last Verified:
    Jan 1, 2014
    Additional relevant MeSH terms:
    Kidney Calculi

    Study Results

    No Results Posted as of Feb 3, 2014