Clinical trial NCT00952315: Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery
Official title: Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stones
Keywords: kidney stones
intracorporeal lithotriptors
kidney stone removal
Lead sponsor: Indiana Kidney Stone Institute
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The investigators plan to compare three different devices that are used to break up large kidney stones during surgery for removal to see if one is faster or more efficient than the others.

Detailed description: Large kidney stones can be removed by a surgical procedure where a small puncture is made through the back into the kidney (percutaneous nephrolithotomy or PNL) but the stones usually need to be broken into smaller pieces before they can be removed through the small surgical incision. There are a number of FDA approved devices commercially available used to break up the stones including pneumatic, ultrasonic, and a combination of the two. Each technology has advantages and disadvantages.

In the last few years there have been new, improved versions of these devices introduced. These improved versions have addressed previous issues of probes clogging or breaking and cumbersome handpiece design. These include the Cyberwand (Cybersonics, Erie, PA), a dual probe ultrasonic device, Swiss Lithoclast Select (EMS, Switzerland) combining the pneumatic and ultrasonic modalities, and a novel device by LMA (Gland, Switzerland) called the StoneBreakerTM, a portable pneumatic device powered by CO2 cartridges.

We propose to compare each of these devices in a randomized study to see if one is better than another at removing kidney stones quickly and efficiently.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo percutaneous nephrolithotomy for at least one kidney stone measuring 2 cm or greater
* Stone easily visible/measurable on plain abdominal imaging (KUB) or CT scan preoperatively
* Age 18 years or older
* Able to give informed consent

Exclusion Criteria:

* Size of single largest stone less than 2 cm
* Pregnancy
* Active urinary tract infection
* Extracorporeal shockwave lithotripsy within the last three months
* Complex stone anticipating multiple access sites
* Stones that are not clearly able to be measured on KUB or CT scan
* Inability to give informed consent
* Age less than 18 years

Primary outcomes:
measure: Stone Clearance Time in mm2/Min
timeFrame: collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket
Secondary outcomes:
measure: Stone-free After First Procedure
timeFrame: Post-operative Day 1
measure: Secondary Procedure Required
timeFrame: Within three days of initial procedure
measure: Ureteral Stent Placed
timeFrame: Intra-operatively
measure: Nephrostomy Tube Placed
timeFrame: Intra-operatively
measure: Use of Other Device
timeFrame: Intra-operatively
measure: EBL>400mL
timeFrame: Intra-operatively
measure: RBC Transfusion
timeFrame: Post-operatively <24 hours
measure: Length of Stay
timeFrame: Post-operatively
measure: Post-operative Complications
timeFrame: Post-operative Days 2 and 3
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: IU Health Physicians Urology
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: London
country: Canada
facility: The University of Western Ontario
state: Ontario
Study officials:
affiliation: IU Health Physicians Urology
name: James E Lingeman, MD
role: PRINCIPAL_INVESTIGATOR
References: