Accuracy of Ultrasound for Detecting Residual Fragments During RIRS

January 15, 2025 updated by: University of California, San Francisco

Diagnostic Accuracy of Ultrasound Versus Fluoroscopy for Detecting Residual Fragments During Retrograde Intrarenal Surgery: a Randomized Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound
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.
Diagnostic test: Ultrasound
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.
No Intervention: Fluoroscopy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy detecting residual fragments during retrograde intrarenal surgery
Time Frame: 4 weeks
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity detecting residual fragments during retrograde intrarenal surgery
Time Frame: 4 weeks
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.
4 weeks
Specificity detecting residual fragments during retrograde intrarenal surgery
Time Frame: 4 weeks
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.
4 weeks
Positive predictive value detecting residual fragments during retrograde intrarenal surgery
Time Frame: 4 weeks
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.
4 weeks
Negative predictive value detecting residual fragments during retrograde intrarenal surgery
Time Frame: 4 weeks
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.
4 weeks
Operative time in minutes
Time Frame: Surgical duration, up to 4 hours
The operative time will be measured from the time the endoscope is inserted into the urethra until the end of the procedure.
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.
Time Frame: 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.
From operation, up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Thomas Chi, M.D., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 27, 2023

Primary Completion (Actual)

December 18, 2024

Study Completion (Actual)

December 18, 2024

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-37292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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