RIRS With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini PCNLfor Kidney Stones
NCT ID: NCT06209931
Last Updated: 2024-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
160 participants
OBSERVATIONAL
2023-10-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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RIRS
Patients were performed under general anesthesia in the oblique supine lithotomy position. Initially, preliminary ureteroscopy was performed with a semirigid 8/9.8 Fr ureteroscope guided by zebra guide wire. Next, the patented tip flexible pressure-controlling ureteral access sheath (UAS,12/14 Fr) was inserted along the guidewire without the fluoroscopic guidance. The fully automatic mode was chosen to operate the platform.The pressure sensory and suctioning channels of UAS were connected to the irrigation and suctioning platform. After water injection, zero calibration was performed at platform. Perfusion flow rate was then set at 100-150 ml/min, the renal pelvic pressure (RPP) control value was set at -15\~5 mmHg, the RPP warning value was set at 20 mmHg, and the RPP maximum value was set at 30 mmHg. Intraoperatively, a holmium laser was used to crush the stone at 1.5-2.0 J/pulse with a frequency of 20-30 pulses/s ( (CHUNHUI, CHINA, 276µm).
RIRS
RIRS with tip flexible pressure-controlling ureteral access sheath versus mini PCNL for the treatment of 2-3-cm kidney stones
MPCNL
Patients were performed under general anesthesia. The patient was first placed in a lithotomy position. A 5 Fr ureteral catheter was then inserted retrogradely into the renal pelvis through cystoscopy or ureteroscopy , and saline was continuously infused to produce artificial hydronephrosis. The patient was then placed in the prone position. Ultrasound-guided percutaneous punctures were made with an 18-gauge coaxial needle into the targeted calix. The puncture point was in the 12th rib infracostal margin, between the posterior axillary line and scapula line. A Zebra guidewire was inserted and fixed. The puncture needle was then removed. After a 0.5-0.7 cm skin incision was made, the percutaneous tract was dilated serially over the guidewire with a fascial dilator to 18Fr. Holmium laser lithotripsy at 1.5-2.0 J/pulse with a frequency of 20-30 pulses/s (CHUNHUI, CHINA, 550µm) was performed with a 18 Fr peel-away sheath.
No interventions assigned to this group
Interventions
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RIRS
RIRS with tip flexible pressure-controlling ureteral access sheath versus mini PCNL for the treatment of 2-3-cm kidney stones
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiology score 1-2
* Kidney stone diameter of 2-3 cm confirmed by CT
* Capable of giving written informed consent, which includes adherence with the requirements of the trial
Exclusion Criteria
* Patients with uncontrolled UTI
* Patients with health or other factors that are absolute contraindications to RIRS or PCNL .Patients unable to understand or complete trial documentation.
18 Years
80 Years
ALL
No
Sponsors
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The Affiliated Ganzhou Hospital of Nanchang University
OTHER
Responsible Party
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Huang Xin
Associate Senior Doctor
Principal Investigators
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Leming Song
Role: STUDY_CHAIR
The Affiliated Ganzhou Hospital of Nanchang University
Locations
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Xiaolin Deng
Ganzhou, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TY-ZKY-2023-045-12
Identifier Type: -
Identifier Source: org_study_id
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