- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06209931
RIRS With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini PCNLfor Kidney Stones
January 14, 2024 updated by: Huang Xin, The Affiliated Ganzhou Hospital of Nanchang University
Retrograde Intrarenal Surgery With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini Percutaneous Nephrolithotomy for the Treatment of 2-3-cm Kidney Stones
The goal of this observational study is to compare the safety and efficacy between RIRS with tip flexible pressure-controlling ureteral access sheath and mini percutaneous nephrolithotripsy(PCNL) for the treatment of 2-3-cm kidney stones.
Study Overview
Detailed Description
Retrograde Intrarenal Stone Surgery (RIRS) has become one of the most common treatments for renal stones.
The development of ureteral access sheath (UAS) is a significant advance in RIRS.
In recent years, various improvements have been made to UAS, especially the emergence of a suction UAS and a tip flexible UAS.
Using the advantages of suction and tip flexible technology, our team developed a tip flexible pressure-controlling UAS, which significantly improves the safety and effectiveness of RIRS.
However, the current guidelines can recommend the indication of RIRS in kidney stones less than 2cm, and percutaneous nephrolithotomy(PCNL) is still preferred for kidney stones larger than 2 cm.
Therefore, this study is the first to compare the safety and efficacy between RIRS with tip flexible pressure-controlling UAS and mini PCNL in the treatment of 2 to 3 cm kidney stones.
Study Type
Observational
Enrollment (Estimated)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xin Huang, M.D.
- Phone Number: 0086-0797-5889867
- Email: sysuhuangxin@126.com
Study Locations
-
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Jiangxi
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Ganzhou, Jiangxi, China, 341000
- Recruiting
- Xiaolin Deng
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Contact:
- Xiaolin Deng
- Phone Number: +867975889867
- Email: 279971368@qq.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Kidney stones were confirmed in all patients by imaging, including urinary tract ultrasonography, intravenous urography, and computed tomography (CT).
Stone size was calculated by CT scans.
Description
Inclusion Criteria:
- Adults aged ≥ 18 years
- 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 abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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).
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RIRS with tip flexible pressure-controlling ureteral access sheath versus mini PCNL for the treatment of 2-3-cm kidney stones
Other Names:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immediate stone-free rate
Time Frame: Postoperative day 1-7
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No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1-7 are defined as stone free.
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Postoperative day 1-7
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Stone-free rate at 1 months
Time Frame: Postoperative 1 month
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No residual stone or stone fragments less than 2 mm on kidney, ureter, and bladder at 1 months are defined as stone free.
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Postoperative 1 month
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Complications up to 3 months post
Time Frame: Postoperative 3 month
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Postoperative 3 month
|
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Operation time
Time Frame: the time from the insertion of the suction sheath and renal puncture to the end of the operation,assessed up to 90 minutes.
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The operation time of RIRS and mini PCNL was defined as the time from the insertion of the suction sheath and renal puncture to the end of the operation
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the time from the insertion of the suction sheath and renal puncture to the end of the operation,assessed up to 90 minutes.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Leming Song, The Affiliated Ganzhou Hospital of Nanchang University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
December 9, 2023
First Submitted That Met QC Criteria
January 14, 2024
First Posted (Estimated)
January 18, 2024
Study Record Updates
Last Update Posted (Estimated)
January 18, 2024
Last Update Submitted That Met QC Criteria
January 14, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TY-ZKY-2023-045-12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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