Kidney Stone, Nephrolithiasis
Conditions
Keywords
Nephrolithiasis, Kidney Stone, ClearPetra, HoYAG, TFL
Brief summary
Mini percutaneous nephrolithotripsy is the treatment of choice for kidney stones over 2cm. This procedure commonly uses laser energy for breaking the stones, and among possible laser platforms, Hoyag and thulium fiber laser are FDA approved. Recently, this procedure has also included the use of vacuum assisted renal access sheaths, which allows suction to be employed together with the breaking of stones. This study intends to compare outcomes when using either laser platforms with suction sheaths in participants undergoing mini percutaneous nephrolithotripsy for the treatment of kidney stones.
Detailed description
Due to the reduced diameter sheath of miniaturized percutaneous nephrolithotripsy (miniPCNL), surgical outcomes commonly rely on stone fragmentation provided by a laser energy source. Holmium:yttrium-aluminum-garnet laser (HoYAG) has long been considered the gold-standard for lithotripsy, but this position has been challenged by the introduction of the thulium fiber laser (TFL) since its approval for clinical use in 2017. In the same manner, the recently developed ClearPetra™(MicroTech Endoscopy®, China) vacuum-assisted renal access sheath (VA-RAS) is a novel technology that allows for concomitant irrigation and suction during the procedure. No prior studies to date have exclusively investigated mini-PCNL outcomes with Ho:YAG and TFL when using VA-RAS. This study addresses the literature paucity regarding the outcomes when utilizing the high-power Ho:YAG with MOSES technology vs. TFL in mini-PCNL with VA-RAS. This study hypothesizes that the Ho:YAG may provide more efficient stone clearance, secondary to its superior ability to fragment stones when compared to the TLF laser, which primarily dusts despite the laser settings utilized.
Interventions
DEVICEHoYAG laser
Patients will be randomly assigned (1:1) to HoYAG laser or TFL laser group for miniPCNL surgery according to standard of care.
DEVICETFL laser platform
Patients will be randomly assigned (1:1) to HoYAG or TFL laser group for MiniPCNL surgery according to standard of care.
Sponsors
University of Kansas Medical Center
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females over 18 years of age 2. Patients with kidney stones, with stone burden larger than 15 mm. 3. Patients undergoing new percutaneous access with primary, supine, unilateral mini-PCNL.
Exclusion criteria
4. Simultaneous use of more than 1 laser platform or other form of fragmentation (e.g., ultrasonic). 5. Patients undergoing simultaneous treatment of contralateral kidney stones during the same procedure. 6. Patients undergoing simultaneous treatment of ureteral stones during the same procedure. 7. Pregnant patients. 8. Presence of genitourinary anatomical abnormalities. 9. Uncorrected coagulopathy. 10. External urinary catheters. 11. Immunosuppressed patients. 12. Non-elective procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone Lithotripsy time between HoYAG and TFL | Procedure | Time from scope insertion to scope removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total operative time between HoYAG and TFL | Procedure | Time from time-out to procedure finish |
| Stone Free Status between ClearPetra and traditional approach | 90 days | Stone free is defined as no residual stones larger than 2mm in post operative CT scan |
| Laser Energy | Procedure | Laser efficiency will be measured by evaluating the laser energy in kilojoules used during the procedure. |
| Laser Time | Procedure | Laser efficiency will be measured by evaluating the time in minutes the laser was used during the procedure. |
Countries
United States
Contacts
CONTACTJane Ledesma
PRINCIPAL_INVESTIGATORBristol Whiles, MD
University of Kansas Medical Center
Outcome results
None listed