HoYAG vs TFL in miniPCNL With ClearPetra
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HoYAG laser, TFL laser platform.
- Who it may be relevant to
- Registry conditions: Nephrolithiasis, Kidney Stone. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Holmium:YAG Laser With MOSES Technology vs Thulium Fiber Laser in Supine Mini-percutaneous Nephrolithotomy With Vacuum-assisted Renal Access Sheath: A Prospective, Randomized Clinical Trial
Overview
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
- Device HoYAG laser
Patients will be randomly assigned (1:1) to HoYAG laser or TFL laser group for miniPCNL surgery according to standard of care. - Device TFL laser platform
Patients will be randomly assigned (1:1) to HoYAG or TFL laser group for MiniPCNL surgery according to standard of care.
Primary outcome measures
- Stone Lithotripsy time between HoYAG and TFL [Time frame: Procedure]
Secondary outcome measures (4)
- Total operative time between HoYAG and TFL [Time frame: Procedure]
- Stone Free Status between ClearPetra and traditional approach [Time frame: 90 days]
- Laser Energy [Time frame: Procedure]
- Laser Time [Time frame: Procedure]
Eligibility criteria
Inclusion criteria
- Males or females over 18 years of age
- Patients with kidney stones, with stone burden larger than 15 mm.
- Patients undergoing new percutaneous access with primary, supine, unilateral mini-PCNL.
Exclusion criteria
- Simultaneous use of more than 1 laser platform or other form of fragmentation (e.g., ultrasonic).
- Patients undergoing simultaneous treatment of contralateral kidney stones during the same procedure.
- Patients undergoing simultaneous treatment of ureteral stones during the same procedure.
- Pregnant patients.
- Presence of genitourinary anatomical abnormalities.
- Uncorrected coagulopathy.
- External urinary catheters.
- Immunosuppressed patients.
- Non-elective procedures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kansas Medical Center — Kansas City
Publications
- Li P, Huang Z, Sun X, Yang T, Wang G, Jiang Y, Ke C, Li J. Comparison of Vacuum Suction Sheath and Non-Vacuum Suction Sheath in Minimally Invasive Percutaneous Nephrolithotomy: A Meta-Analysis. J Invest Surg. 2022 May;35(5):1145-1152. doi: 10.1080/08941939.2021.1995538. Epub 2021 Dec 13. PMID 34902273
- Liu Y, Zhu W, Zeng G. Percutaneous nephrolithotomy with suction: is this the future? Curr Opin Urol. 2021 Mar 1;31(2):95-101. doi: 10.1097/MOU.0000000000000854. PMID 33470685
- Traxer O, Keller EX. Thulium fiber laser: the new player for kidney stone treatment? A comparison with Holmium:YAG laser. World J Urol. 2020 Aug;38(8):1883-1894. doi: 10.1007/s00345-019-02654-5. Epub 2019 Feb 6. PMID 30729311
Identifiers
NCT: NCT07087977 · STUDY00161413