Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

NCT ID: NCT00873054

Last Updated: 2014-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-01-31

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.

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.

Conditions

Kidney Stones

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CAMC Health System

OTHER

Sponsor Role: lead

Responsible Party

Samuel Deem, DO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julio G. Davalos, MD

Role: PRINCIPAL_INVESTIGATOR

CAMC Medical Staff - with admitting privileges

Frederick Martinez, M.D.

Role: PRINCIPAL_INVESTIGATOR

CAMC Medical Staff - with admitting privileges

Locations

Urology Center of Charleston

Charleston, West Virginia, United States

Countries

United States

References

Setthawong V, Srisubat A, Potisat S, Lojanapiwat B, Pattanittum P. Extracorporeal shock wave lithotripsy (ESWL) versus percutaneous nephrolithotomy (PCNL) or retrograde intrarenal surgery (RIRS) for kidney stones. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007044. doi: 10.1002/14651858.CD007044.pub4.

Reference Type: DERIVED

PMID: 37526261 (View on PubMed)

Other Identifiers

08-08-2078

Identifier Type: -

Identifier Source: org_study_id