Urolithiasis Clinical Trial
Official title:
A Prospective and Randomized Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy
Purpose:
The aim of this present study is to compare the result of fluoroscopy, ultrasonography (US)
and US combined with fluoroscopy in the guidance of minimally invasive percutaneous
nephrolithotomy (MPCNL).
Methods:
The investigators will enroll 450 patients who are candidates for MPCNL in our study. By
simple random sampling technique, patients will be assigned to three 150-patient groups
(group 1, US-guided MPCNL, group 2, fluoroscopy-guided MPCNL and group 3, US combined with
fluoroscopy-guided MPCNL). In addition to approaches in guidance of MPCNL, the rest of the
procedure is the same in all three groups.The end point of the study is the comparison of
outcome of procedure including stone free rate, transfusion rate, operation time, access
time, length of stay and complications.
Purpose:
Recently, PCNL or MPCNL is widely used as the most popular choice to treat patients with all
types of renal stones. Successful puncture to the desired renal calyx is the key step for
the operation. Nowadays puncture for renal access can be achieve using not only US guidance
but fluoroscopy guidance as well. However, it is clear that there is a lack of randomized
controlled data comparing fluoroscopy, US and US combined with fluoroscopy in the guidance
of MPCNL. Consequently, we performed this randomized controlled trial to obtain higher grade
evidence.The aim of this present study is to compare the result of fluoroscopy, US and US
combined with fluoroscopy in the guidance of MPCNL.
Methods:
We will enroll 450 patients who are candidates for MPCNL in our study. By simple random
sampling technique, patients will be assigned to three 150-patient groups (group 1,
US-guided MPCNL, group 2, fluoroscopy-guided MPCNL and group 3, US combined with
fluoroscopy-guided MPCNL).
All the patients will be diagnosed definitely before operations with kidney, ureter, and
bladder (KUB), intravenous pyelography (IVP), US and/or CT.
All procedures are performed by urologists in our center, with assistance from an
endourology fellow.
Surgical technique:
Under general or epidural anaesthesia, each patient is initially placed in the lithotomy
position, and a 5 Fr ureteric catheter is advanced to the kidney and fixed with a 16 Fr
Foley catheter. Then the patient is turned to the prone position.
Group 1: US-guided MPCNL The puncture is made with an 18-gauge needle using an ultrasound
probe. After the desirable calix is reached, a flexible-tip guidewire is introduced. We
attempt to manipulate the guidewire down to the ureter. If this is not successful, the
second choice is to allow the guidewire to coil in a more distant calix. The length of the
needle from skin to the collecting system is measured to ensure that the length of dilator
is appropriate. The access tract is dilated from 8 Fr to a maximum 18/20 Fr using fascial
dilator. We defined access to the collecting system as gaining entry to the targeted urinary
system and desired calix.
Lithotripsy is performed using either pneumatic lithotriptor or holmium laser. When multiple
nephrostomy tracts are necessary to remove the stones, same technique is employed for each
of the tracts.
Complete stone clearance is confirmed using US at completion of the procedure. We routinely
put a double J ureteral catheter into the ureter which is to be removed about 3-4 weeks
later after the operation in the out-patients clinic. At the end of the procedure
nephrostomy tubes are placed in both groups. The tubes are removed when the drainage from
nephrostomy tubes being grossly clear.
Group 2 fluoroscopy-guided MPCNL Patients in group 2 have the standard fluoroscopy-guided
renal access before MPCNL. Air or contrast medium is injected through the ureteral catheter,
the target calix is identified. For tract dilatation fascial dilators are used under
fluoroscopic guidance.
Complete stone clearance is confirmed fluoroscopically at completion of the procedure.
The rest of the procedure is the same as described for patients in group 1.
Group 3 US combined with fluoroscopy-guided MPCNL:
Under the guidance of ultrasound, the coaxial needle is placed in the desired calyx. A
floppy-tipped guidewire is then passed through the needle into the collecting system. The
working channel is then dilated under X-ray.
US and X-ray check for residual stone fragments are performed at the end of the procedure.
The rest of the procedure is the same as described for patients in group 1.
Data collection:
Data for the three groups -demographic characteristics, access success, access time,
duration of radiation exposure, site of target calix, site of access, Hb decrease, duration
of postoperative hospital stay, complications (modified Clavien system), stone clearance
(SFR after single procedure and final SFR) and the need for auxiliary treatment - are
compared.
The primary end point of the study is the comparison of outcome of procedure including stone
free rate, transfusion rate, operation time, access time, length of stay and complications.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04746378 -
PRedictive Accuracy of Initial Stone Burden Evaluation.
|
||
Recruiting |
NCT05100017 -
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
|
N/A | |
Recruiting |
NCT04021381 -
Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi
|
Phase 3 | |
Terminated |
NCT01431378 -
Pilot Study of Model Based Iterative Reconstruction Using 64-Slice
|
N/A | |
Completed |
NCT01451931 -
Study of Tomography of Nephrolithiasis Evaluation
|
Phase 4 | |
Completed |
NCT02895711 -
Radiation Dose of Pediatric Patients During Ureteroscopy
|
||
Completed |
NCT01295879 -
Vitamin D Repletion in Stone Formers With Hypercalciuria
|
Phase 4 | |
Completed |
NCT05340075 -
Staged Bilateral Percutaneous Nephrolithotomy
|
||
Recruiting |
NCT03919227 -
Measurement of Resistance During UAS Insertion Procedure in RIRS
|
N/A | |
Recruiting |
NCT03717285 -
Under Direct Vision vs Under Non Direct Vision of Insertion of UAS in RIRS
|
N/A | |
Completed |
NCT05340088 -
Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
|
||
Completed |
NCT05032287 -
Medical Expulsive Therapy Post-SWL For Renal Stones
|
N/A | |
Recruiting |
NCT05701098 -
SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)
|
N/A | |
Not yet recruiting |
NCT04080973 -
Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia
|
N/A | |
Terminated |
NCT01736358 -
The Use of Intranasal Ketoralac for Pain Management (Sprix)
|
Phase 4 | |
Completed |
NCT01792765 -
Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach
|
N/A | |
Completed |
NCT06211842 -
Genetic Variations That Increase the Risk for Calcium Kidney Stones: a Family-based Study
|
||
Not yet recruiting |
NCT02214836 -
Ultrasound Imaging of Kidney Stones and Lithotripsy
|
N/A | |
Not yet recruiting |
NCT04606758 -
Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease
|
N/A | |
Terminated |
NCT01873690 -
Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI)
|
Phase 3 |