The purpose of this study is to assess the accuracy of ultrasound and traditional fluoroscopy to find the residual fragments before retrograde intrarenal surgery is complete. This would ultimately limit the need for radiation exposure and improve the quality of clinical care given to patients and healthcare teams.
Ultrasound is currently gaining popularity as an alternative imaging modality for the diagnosis and treatment of urolithiasis. However, the benefit of ultrasound on the diagnostic accuracy of detecting residual fragments during retrograde intrarenal surgery (RIRS) has never been evaluated in a randomized study. Its use would reduce radiation exposure for patients and care team members as well as improve stone free clearance rates for surgery. Therefore, The investigators plan to conduct a randomized trial to assess the diagnostic accuracy of ultrasound and fluoroscopy in conjunction with endoscopic examination for detecting residual stone fragments during retrograde intrarenal surgery. After admission, approximately 172 subjects will be randomized in a 1:1 ratio to receive ultrasound or fluoroscopy before completing RIRS. Subsequently, four weeks after the operation, the investigators will compare with routine low-dose non-contrast computed tomography as a gold standard for detecting residual fragments. If ultrasound is more accurate than fluoroscopy in detecting residual fragments, the investigators will encourage this approach as it can reduce radiation exposure for patients and healthcare professionals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
Before completing retrograde intrarenal surgery, a complete endoscopic examination will be performed along with ultrasound instead of fluoroscopy by the same endourologist to determine the size of the largest residual fragment.
University of California, San Francisco
San Francisco, California, United States
Diagnostic accuracy detecting residual fragments during retrograde intrarenal surgery
The diagnostic accuracy of ultrasound and fluoroscopy will be measured in conjunction with endoscopic examination for detecting residual fragments during retrograde intrarenal surgery for renal stones treatment by the same endourologist to determine the size of the largest residual fragment, categorizing them as stone free, ≤ 2 mm, or \>2 mm, and compared with routine low-dose non-contrast computed tomography by a radiologist blinded to surgery and intraoperative imaging, categorizing them as stone free, ≤ 2 mm, or \>2 mm. The results will be compared for accuracy.
Time frame: 4 weeks
Sensitivity detecting residual fragments during retrograde intrarenal surgery
The sensitivity of ultrasound and fluoroscopy will be measured in conjunction with endoscopic examination for detecting residual fragments during retrograde intrarenal surgery for renal stones treatment by the same endourologist to determine the size of the largest residual fragment, categorizing them as stone free, ≤ 2 mm, or \>2 mm, and compared with routine low-dose non-contrast computed tomography by a radiologist blinded to surgery and intraoperative imaging, categorizing them as stone free, ≤ 2 mm, or \>2 mm. The results will be compared for sensitivity.
Time frame: 4 weeks
Specificity detecting residual fragments during retrograde intrarenal surgery
The specificity of ultrasound and fluoroscopy will be measured in conjunction with endoscopic examination for detecting residual fragments during retrograde intrarenal surgery for renal stones treatment by the same endourologist to determine the size of the largest residual fragment, categorizing them as stone free, ≤ 2 mm, or \>2 mm, and compared with routine low-dose non-contrast computed tomography by a radiologist blinded to surgery and intraoperative imaging, categorizing them as stone free, ≤ 2 mm, or \>2 mm. The results will be compared for specificity.
Time frame: 4 weeks
Positive predictive value detecting residual fragments during retrograde intrarenal surgery
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The positive predictive value of ultrasound and fluoroscopy will be measured in conjunction with endoscopic examination for detecting residual fragments during retrograde intrarenal surgery for renal stones treatment by the same endourologist to determine the size of the largest residual fragment, categorizing them as stone free, ≤ 2 mm, or \>2 mm, and compared with routine low-dose non-contrast computed tomography by a radiologist blinded to surgery and intraoperative imaging, categorizing them as stone free, ≤ 2 mm, or \>2 mm. The results will be compared for positive predictive value.
Time frame: 4 weeks
Negative predictive value detecting residual fragments during retrograde intrarenal surgery
The negative predictive value of ultrasound and fluoroscopy will be measured in conjunction with endoscopic examination for detecting residual fragments during retrograde intrarenal surgery for renal stones treatment by the same endourologist to determine the size of the largest residual fragment, categorizing them as stone free, ≤ 2 mm, or \>2 mm, and compared with routine low-dose non-contrast computed tomography by a radiologist blinded to surgery and intraoperative imaging, categorizing them as stone free, ≤ 2 mm, or \>2 mm. The results will be compared for negative predictive value.
Time frame: 4 weeks
Operative time in minutes
The operative time will be measured from the time the endoscope is inserted into the urethra until the end of the procedure.
Time frame: Surgical duration, up to 4 hours
Surgical complications into grade I to V on the modified Clavien-Dindo classification from operation, up to 4 weeks.
Surgical complications will be categorized according to the modified Clavien-Dindo classification consisted of 5 severity grades. Complications are within 4 weeks post-operation ranging from Grade I to V. Grade I include any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II complications are defined as complications requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III complications are defined as complications requiring surgical, endoscopic or radiological intervention; IIIa intervention not under general anesthesia and IIIb intervention under general anesthesia. Grade IV complications are defined as life-threatening complication requiring IC/ICU management; IVa single organ dysfunction (including dialysis) and IVb multiorgan dysfunction. Grade V complications indicated death of a patient due to a complication.
Time frame: From operation, up to 4 weeks