Clinical trial NCT03608098: Long Pulse Versus Short Pulse Laser Dusting for Renal Stones
Official title: Long Pulse Versus Short Pulse Laser Dusting for Renal Stones
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney Stone
Ureter Stone
Renal Stone
Keywords: Basketing
Dusting
Holmium Laser
Laser Lithotripsy
Intracorporeal Lithotripsy
Urolithiasis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Cogenix Medical Corporation
First posted: 2018-07-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects enrolled in the study will be randomized to either short pulse or long pulse for treatment of their stones. The date of treatment will be decided between the subject and the treating surgeon. All treatments will be performed using the standard of care and will be performed in the same fashion as procedures for patients not enrolled in the study. There is no modification of the techniques used to remove the stones. Post operatively, we plan to discharge all subjects home from the recovery unit. All subjects will be seen one week to one month after surgery for stent removal and a low dose CT of the abdomen and pelvis to assess stone free rates which is standard for all stone patients.
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to compare how well two treatments work for removing kidney stones. The two study groups include ureteroscopy with long/short pulse lithotripsy to remove kidney stones. Both of these options are considered standard of care and are used currently in surgery.

Detailed description: This study will compare two types of laser lithotripsy to see the pulse duration to determine which settings are more effective. This is a randomized control trial with subjects randomized to either long pulse or a short pulse group. Those subjects with a single kidney/ureter stone measuring up to 20 mm will be eligible for the study. The procedures will be performed using the standard of care instruments and techniques but the pulse type setting in surgery will be constant. Some Holmium laser devices provide the option to modulate the pulse duration. A longer laser pulse duration (700 μs or 1500 μs) as compared to a traditional pulse duration (300 μs or 350 μs) has been demonstrated in vitro studies to provide effective stone disintegration while reducing laser fiber tip degradation and stone retropulsion. Both the long and the short setting can dust the stone and currently we alternate in each procedure from one setting to the other and it is unclear which setting is more effective. No changes to operative technique will be performed for subjects in the study vs regular patients undergoing the same procedure. All subjects will be seen one week to one month after surgery for stent removal and follow up.

Eligibility criteria: Inclusion Criteria:

* Kidney/ureter single stone between up to 2 cm
* Age over 18 years
* Two kidneys

Exclusion Criteria:

* Solitary Kidney
* Age under 18
* Pregnancy

Primary outcomes:
measure: Stone free rate
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Operative duration time
timeFrame: 1 month after surgery
measure: Need for Secondary Procedures
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jorge Gutierrez-Aceves, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson CP, Pace KT, Pais VM, Pearle MS, Preminger GM. American Urological Association (AUA) guideline surgical management of stones: American Urological Association Surgical Management 2016; April:1-50.
citation: Chew BH, Brotherhood HL, Sur RL, Wang AQ, Knudsen BE, Yong C, Marien T, Miller NL, Krambeck AE, Charchenko C, Humphreys MR. Natural History, Complications and Re-Intervention Rates of Asymptomatic Residual Stone Fragments after Ureteroscopy: a Report from the EDGE Research Consortium. J Urol. 2016 Apr;195(4 Pt 1):982-6. doi: 10.1016/j.juro.2015.11.009. Epub 2015 Nov 14.
citation: Matlaga et al. Ureteroscopic Laser Lithotripsy: A Review of Dusting Versus Fragmentation With Extraction. Journal of Endourology. October 2017. Epub ahead of publication.
citation: Li R, Ruckle D, Keheila M, Maldonado J, Lightfoot M, Alsyouf M, Yeo A, Abourbih SR, Olgin G, Arenas JL, Baldwin DD. High-Frequency Dusting Versus Conventional Holmium Laser Lithotripsy for Intrarenal and Ureteral Calculi. J Endourol. 2017 Mar;31(3):272-277. doi: 10.1089/end.2016.0547. Epub 2017 Jan 16.
citation: Wollin DA, Ackerman A, Yang C, Chen T, Simmons WN, Preminger GM, Lipkin ME. Variable Pulse Duration From a New Holmium:YAG Laser: The Effect on Stone Comminution, Fiber Tip Degradation, and Retropulsion in a Dusting Model. Urology. 2017 May;103:47-51. doi: 10.1016/j.urology.2017.01.007. Epub 2017 Jan 16.