Ho:YAG Laser Versus Thulium Laser for the Management of 2-4cm Kidney Stones During SMP
1 other identifier
interventional
682
1 country
1
Brief Summary
With the rapid development of medical equipment and the increasing experience, minimally invasive percutaneous nephrolithotomy (mini-PCNL) has been a well established modality for the management of upper urinary tract stones. The introduction of negative pressure suction technology into mini-PCNL can actively suck out the perfusion fluid and stone fragments, therefore to speed up stone removal efficency and keep a low intrarenal pressure, and was called suction mini-PCNL (SMP). The common energy sources for SMP were pneumatic ballistic lithotripsy and Ho:YAG laser. The handle of pneumatic ballistic lithotripsy was heavy and can not be fixed on the nephroscope, furthermore, the fragments in pneumatic ballistic lithotripsy was large, therefore the active suction and discharge of stone fragments can not be well completed at the same time of lithotripsy. However, the Ho:YAG laser can well match the requirement of SMP that lithotripsy and suction can work at the same time. Recently, thulium fiber laser (TFL) was also used for lithotripsy. The versatility of TFL, including high frequencies and reduced retropulsion may result in higher ablation efficiency compared to Ho:YAG laser. However, there is no clinical study on the difference between Ho:YAG laser and thulium laser in SMP, which limits the reasonable choice of laser in SMP to a certain extent. So, the investigators would like to have an international multi-centre RCT to compare the therapeutic effects of SMP with Ho:YAG laser versus TFL in the treatment of 2-4cm renal calculi, so as to provide high-level evidence to support for clinical selection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2022
CompletedFirst Posted
Study publicly available on registry
January 13, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 13, 2022
January 1, 2022
2 years
January 4, 2022
January 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Operation time
Operation time is defined as the time from puncture to the placement of the nephrostomy tube
Intraoperative (the time from puncture to the placement of the nephrostomy tube)
Secondary Outcomes (3)
Stone free rate (SFR)
1 month after removing the pigtail stent
postoperative fever
≤ 1month postoperatively
Complications is defined as any adverse event occurred
intraoperatively or ≤ 1month postoperatively
Study Arms (2)
Experimental: Patients in Group 1 undergo Ho:YAG laser
EXPERIMENTALExperimental: Patients in Group 2 undergo TFL
EXPERIMENTALInterventions
Under the guidance of B-ultrasound or X-ray, the appropriate target calyx was punctured with an 18G puncture needle.Percutaneous tract was established with 18Fr suction sheath. 12Fr nephroscope and 360um Ho:YAG laser fiber was used for lithotripsy.Kidney stones were fragmented by Ho:YAG lasers, and sucked out by the suction sheath.
Under the guidance of B-ultrasound or X-ray, the appropriate target calyx was punctured with an 18G puncture needle.Percutaneous tract was established with 18Fr suction sheath. 12Fr nephroscope and 360um TFL fiber was used for lithotripsy.Kidney stones were fragmented by TFL, and sucked out by the suction sheath.
Eligibility Criteria
You may qualify if:
- cm kidney stones.
- Aged 18-70 years.
- SMP with Ho:YAG laser or TFL.
You may not qualify if:
- Transplanted kidney, solitary kidney, horseshoe kidney, urinary diversion, urethra deformity and other special cases.
- If empyema was found during SMP, the nephrostomy tube was retained and the patient was excluded from the trail.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology, Minimally invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong,China, 510230, China
Related Publications (1)
Becker B, Gross AJ, Netsch C. Ho: YaG laser lithotripsy: recent innovations. Curr Opin Urol. 2019 Mar;29(2):103-107. doi: 10.1097/MOU.0000000000000573.
PMID: 30407221BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guohua Zeng, Ph.D & MD
The First Affiliated Hospital of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president
Study Record Dates
First Submitted
January 4, 2022
First Posted
January 13, 2022
Study Start
March 1, 2022
Primary Completion
March 1, 2024
Study Completion
December 1, 2024
Last Updated
January 13, 2022
Record last verified: 2022-01