Kidney Stones
Conditions
Keywords
kidney stones, intracorporeal lithotriptors, kidney stone removal
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.
Interventions
DEVICECyberwand
Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
DEVICEStonebreaker
Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
DEVICELithoclast Select
Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented
Sponsors
Indiana Kidney Stone Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone Clearance Time in mm2/Min | collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket | Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Procedure Required | Within three days of initial procedure | Number of participants who required a secondary kidney stone removal procedure |
| Ureteral Stent Placed | Intra-operatively | Participants requiring a ureteral stent to be placed after initial stone removal procedure |
| Nephrostomy Tube Placed | Intra-operatively | Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure |
| Use of Other Device | Intra-operatively | Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite |
| Stone-free After First Procedure | Post-operative Day 1 | Number of participants deemed stone-free after initial stone-removal surgery |
| RBC Transfusion | Post-operatively <24 hours | Number of participants who required a blood transfusion post-operatively |
| Length of Stay | Post-operatively | Number of days participants were in hospital. Operative day is Day 1. |
| Post-operative Complications | Post-operative Days 2 and 3 | Number of participants who experienced surgery-related post-op complications |
| EBL>400mL | Intra-operatively | Number of participants with an estimated blood loss greater than 400mL |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stonebreaker Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. | 64 |
| Lithoclast Select Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.
Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented | 66 |
| Cyberwand The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.
Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented. | 71 |
| Total | 201 |
Baseline characteristics
| Characteristic | Lithoclast Select | Cyberwand | Total | Stonebreaker |
|---|---|---|---|---|
| Age, Continuous | 58.1 years | 57.4 years | 57 years | 55.2 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment North America | 66 participants | 71 participants | 201 participants | 64 participants |
| Sex: Female, Male Female | 34 Participants | 36 Participants | 102 Participants | 32 Participants |
| Sex: Female, Male Male | 32 Participants | 35 Participants | 99 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 66 | 0 / 71 |
| other Total, other adverse events | 18 / 64 | 19 / 66 | 16 / 71 |
| serious Total, serious adverse events | 0 / 64 | 0 / 66 | 0 / 71 |
Outcome results
Primary
Stone Clearance Time in mm2/Min
Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)
Time frame: collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stonebreaker | Stone Clearance Time in mm2/Min | 24.0 mm^2/min | Standard Deviation 13.9 |
| Lithoclast Select | Stone Clearance Time in mm2/Min | 28.9 mm^2/min | Standard Deviation 16.2 |
| Cyberwand | Stone Clearance Time in mm2/Min | 32.3 mm^2/min | Standard Deviation 23.4 |
Secondary
EBL>400mL
Number of participants with an estimated blood loss greater than 400mL
Time frame: Intra-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stonebreaker | EBL>400mL | 4 Participants |
| Lithoclast Select | EBL>400mL | 2 Participants |
| Cyberwand | EBL>400mL | 3 Participants |
Secondary
Length of Stay
Number of days participants were in hospital. Operative day is Day 1.
Time frame: Post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stonebreaker | Length of Stay | 1.9 Days | Standard Deviation 1.5 |
| Lithoclast Select | Length of Stay | 2.5 Days | Standard Deviation 2.1 |
| Cyberwand | Length of Stay | 2.6 Days | Standard Deviation 2.5 |
Secondary
Nephrostomy Tube Placed
Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure
Time frame: Intra-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stonebreaker | Nephrostomy Tube Placed | 55 Participants |
| Lithoclast Select | Nephrostomy Tube Placed | 59 Participants |
| Cyberwand | Nephrostomy Tube Placed | 63 Participants |
Secondary
Post-operative Complications
Number of participants who experienced surgery-related post-op complications
Time frame: Post-operative Days 2 and 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stonebreaker | Post-operative Complications | 10 Participants |
| Lithoclast Select | Post-operative Complications | 10 Participants |
| Cyberwand | Post-operative Complications | 11 Participants |
Secondary
RBC Transfusion
Number of participants who required a blood transfusion post-operatively
Time frame: Post-operatively <24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stonebreaker | RBC Transfusion | 3 Participants |
| Lithoclast Select | RBC Transfusion | 2 Participants |
| Cyberwand | RBC Transfusion | 2 Participants |
Secondary
Secondary Procedure Required
Number of participants who required a secondary kidney stone removal procedure
Time frame: Within three days of initial procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stonebreaker | Secondary Procedure Required | 15 Participants |
| Lithoclast Select | Secondary Procedure Required | 16 Participants |
| Cyberwand | Secondary Procedure Required | 24 Participants |
Secondary
Stone-free After First Procedure
Number of participants deemed stone-free after initial stone-removal surgery
Time frame: Post-operative Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stonebreaker | Stone-free After First Procedure | 33 Participants |
| Lithoclast Select | Stone-free After First Procedure | 43 Participants |
| Cyberwand | Stone-free After First Procedure | 39 Participants |
Secondary
Ureteral Stent Placed
Participants requiring a ureteral stent to be placed after initial stone removal procedure
Time frame: Intra-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stonebreaker | Ureteral Stent Placed | 3 Participants |
| Lithoclast Select | Ureteral Stent Placed | 4 Participants |
| Cyberwand | Ureteral Stent Placed | 5 Participants |
Secondary
Use of Other Device
Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite
Time frame: Intra-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stonebreaker | Use of Other Device | 8 Participants |
| Lithoclast Select | Use of Other Device | 9 Participants |
| Cyberwand | Use of Other Device | 5 Participants |