Clinical trial NCT05535816: Accuracy of Ultrasound for Detecting Residual Fragments During RIRS
Official title: Diagnostic Accuracy of Ultrasound Versus Fluoroscopy for Detecting Residual Fragments During Retrograde Intrarenal Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stone, Kidney
Ultrasound Therapy; Complications
Keywords: residual stone
ureteroscopy
ultrasound
diagnostic accuracy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18.
* Consecutive patients with a diagnosis of renal stone or ureteral stone with a plan to undergoing RIRS for stone removal.

Exclusion Criteria:

* Patients who decline informed consent.
* Pregnancy
* Kidney transplantation
* Ectopic kidney
* Patients undergoing concurrent bilateral stone removal surgery.
* Patients whose pain cannot be controlled when presenting at the Emergency Department.

Primary outcomes:
measure: Diagnostic accuracy detecting residual fragments during retrograde intrarenal surgery
timeFrame: 4 weeks
Secondary outcomes:
measure: Sensitivity detecting residual fragments during retrograde intrarenal surgery
timeFrame: 4 weeks
measure: Specificity detecting residual fragments during retrograde intrarenal surgery
timeFrame: 4 weeks
measure: Positive predictive value detecting residual fragments during retrograde intrarenal surgery
timeFrame: 4 weeks
measure: Negative predictive value detecting residual fragments during retrograde intrarenal surgery
timeFrame: 4 weeks
measure: Operative time in minutes
timeFrame: Surgical duration, up to 4 hours
measure: Surgical complications into grade I to V on the modified Clavien-Dindo classification from operation, up to 4 weeks.
timeFrame: From operation, up to 4 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Chi, M.D.
role: PRINCIPAL_INVESTIGATOR
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