Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

NCT00873054 | Completed

• 1 other identifier: 08-08-2078
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stones

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Urology Center of Charleston

Charleston, West Virginia, 25301, United States

Location

Related Publications (1)

• 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.

  PMID: 37526261 DERIVED

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Julio G. Davalos, MD

  CAMC Medical Staff - with admitting privileges

  PRINCIPAL INVESTIGATOR

• Frederick Martinez, M.D.

  CAMC Medical Staff - with admitting privileges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: October 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2011
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

US (1)