Accuracy of Ultrasound for Detecting Residual Fragments During RIRS

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Stone, Kidney; Ultrasound Therapy; Complications

Treatments: Diagnostic Test: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT05535816

22-37292

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Ultrasound

Experimental group

Description:

Before completing retrograde intrarenal surgery, a complete endoscopic examination will be performed along with ultrasound by the same endourologist to determine the size of the largest residual fragment.

Treatment:

Diagnostic Test: Ultrasound

Fluoroscopy

No Intervention group

Description:

Standard of care, control Before completing retrograde intrarenal surgery, a complete endoscopic examination will be performed along with fluoroscopy by the same endourologist to determine the size of the largest residual fragment.