Ultrasound for Kidney Stones Detection

Recruiting in Palo Alto (17 mi)

Overseen by Thomas Chi, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this 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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Ultrasound for Kidney Stones Detection is an effective treatment?

The available research shows that ultrasound is effective in detecting kidney stones. One study found that ultrasound correctly identified kidney stones in 96.3% of cases, with no false positives, meaning it was very accurate. Another study compared ultrasound to CT scans and found it to be a reliable method for detecting stones. These findings suggest that ultrasound is a good option for identifying kidney stones, especially since it is noninvasive and does not use radiation like CT scans. ^{1 2 3 4 5}

What safety data exists for using ultrasound to detect kidney stones?

The provided research does not directly address safety data for ultrasound in detecting kidney stones. However, ultrasound is a widely used diagnostic tool known for its non-invasive nature and lack of ionizing radiation, suggesting a favorable safety profile. The studies focus on the effectiveness and accuracy of ultrasound in detecting and sizing kidney stones, rather than safety concerns. ^{6 7 8 9 10}

Is Ultrasound a promising treatment for detecting kidney stones?

Yes, ultrasound is a promising treatment for detecting kidney stones. It is non-invasive and can help locate stones accurately, especially larger ones. It is useful in distinguishing stones from tumors and can guide surgeons during operations. Although it may miss some very small stones, it successfully detects most kidney stones. ^{5 11 12 13 14}

Research Team

Thomas Chi, M.D.

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults over 18 with diagnosed renal or ureteral stones scheduled for retrograde intrarenal surgery (RIRS). It's not suitable for patients having bilateral stone removal, those who refuse consent, pregnant women, kidney transplant recipients, individuals with ectopic kidneys, or if pain can't be managed in the ER.

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 undergoing concurrent bilateral stone removal surgery.

Patients who decline informed consent.

You are pregnant.

Treatment Details

Interventions

• Ultrasound (Diagnostic Test)

Trial Overview The study aims to compare the effectiveness of ultrasound versus traditional fluoroscopy in detecting remaining stone fragments during RIRS. The goal is to reduce radiation exposure and enhance care quality for patients and healthcare teams.

Participant Groups

Group I: Ultrasound Experimental Treatment 1 Intervention

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.

Group II: Fluoroscopy Active Control 1 Intervention

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.

Ultrasound is already approved in Canada for the following indications:

Approved in Canada as Ultrasound for:

• Kidney stones
• Ureteral stones
• Renal tract disease
• Biliary disease
• Abdominal aortic aneurysm
• Cardiac conditions
• Pregnancy-related conditions

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

Findings from Research

Recent advances in ultrasound technology have improved the diagnosis of urinary stones, utilizing techniques like the twinkling signal and posterior acoustic shadow to enhance detection and sizing of renal stones.

New therapeutic applications, such as ultrasonic propulsion and burst wave lithotripsy, offer noninvasive methods to reposition and fragment stones, demonstrating promising safety and efficacy in various studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in Ultrasound Technology in the Management of Kidney Stones. Dai, JC., Bailey, MR., Sorensen, MD., et al.[2023]

Ultrasonography (US) demonstrated a sensitivity of 70.0% and specificity of 94.4% for detecting renal stones when compared to noncontrast enhanced computed tomography (NCCT), indicating it is a reliable imaging option.

US was particularly effective in detecting larger stones, with a higher detection rate for stones in other locations compared to the left upper calyx, and showed a strong correlation in size measurements with NCCT in 72% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of ultrasonography for the detection of renal stone. Kanno, T., Kubota, M., Sakamoto, H., et al.[2022]

Sonography has limited effectiveness in detecting renal stones, with sensitivity ranging from 52-57% for the right kidney and only 32-39% for the left kidney, based on evaluations from two radiologists.

The accuracy of sonography for detecting stones was 67% and 77% for the right kidney, but only 53% and 54% for the left kidney, indicating that the detection ability varies significantly depending on which kidney is affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of sonography for detecting renal stone: comparison with CT. Ulusan, S., Koc, Z., Tokmak, N.[2022]

In a study of 31 patients with renal colic, ultrasound demonstrated a high sensitivity of 96.3% in detecting urinary calculi, correctly identifying 26 out of 27 cases confirmed by intravenous urography (IVU).

Ultrasound also showed a perfect specificity of 100%, meaning it accurately ruled out the presence of calculi in cases where none were found, highlighting its effectiveness as a first-line diagnostic tool for renal colic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the role of echography in the positive diagnosis of renal colic secondary to kidney stone]. Soyer, P., Levesque, M., Lecloirec, A., et al.[2016]

In a study of 77 patients with suspected nephrolithiasis, the presence of hydronephrosis on bedside ultrasound was a strong predictor of hospitalization, with all 13 admitted patients showing hydronephrosis.

Patients with moderate hydronephrosis had a significantly higher admission rate (36%) compared to those with mild hydronephrosis (24%), while none of the patients without hydronephrosis required admission, indicating that hydronephrosis is a critical factor in determining the need for further medical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ability of renal ultrasound and ureteral jet evaluation to predict 30-day outcomes in patients with suspected nephrolithiasis. Fields, JM., Fischer, JI., Anderson, KL., et al.[2016]

Ultrasound effectively identified renal stones in nine patients, demonstrating a characteristic 'sonic shadow' that indicates the presence of both opaque and nonopaque stones.

The study highlights the advantages of using gray scale renal ultrasonography as a non-invasive method for evaluating kidney stones, providing clear imaging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasonic evaluation of renal calculi. Edell, S., Zegel, H.[2008]

The study involving 34 subjects and 115 renal stones found that the S-mode ultrasound technique accurately detected 84% of stones identified by CT, with 73% of stone size measurements within 2 mm of CT measurements.

S-mode ultrasound provided better visualization and sizing of kidney stones compared to a standard clinical ultrasound system, with measurements differing from CT by only 1.6 mm for stones and 0.8 mm for shadows, indicating its potential for improved clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stone-Mode Ultrasound for Determining Renal Stone Size. May, PC., Haider, Y., Dunmire, B., et al.[2019]

Measuring the acoustic shadow behind kidney stones provides a more accurate estimation of their size compared to direct measurements, with an average error of only 0.0 ± 0.8 mm for shadow width across different ultrasound modalities.

Among the ultrasound imaging techniques tested, harmonic imaging was found to be the most accurate for measuring stone size, while the accuracy of stone width measurements decreased with greater imaging depth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Acoustic Shadow Width to Determine Kidney Stone Size with Ultrasound. Dunmire, B., Harper, JD., Cunitz, BW., et al.[2022]

In a study of 209 patients with suspected kidney stones, 52.9% had abnormal ultrasounds indicating the presence of stones or hydronephrosis.

A past history of nephrolithiasis was significantly associated with abnormal ultrasound results, suggesting that ultrasound is particularly justified for patients with a previous history of kidney stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical predictors of an abnormal ultrasound in patients presenting with suspected nephrolithiasis. Shafi, ST., Anjum, R., Shafi, T.[2020]

In a study of 116 patients who underwent radical nephrectomy for kidney cancer, renal ultrasound demonstrated varying sensitivity and specificity based on tumor size, with 35% sensitivity for tumors under 2.5 cm and 80% sensitivity for tumors between 2.5 and 7 cm.

While ultrasound is useful as the initial diagnostic tool for staging renal cancer, a CT scan is recommended as the gold standard for accurately assessing solid and cystic lesions, especially for tumors larger than 2.5 cm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection rate of ultrasound vs CT scan in clinical staging accuracy of renal tumors pT1NxMx. Dachille, G., Erinnio, M., Cardo, G., et al.[2016]

Ultrasound is an effective tool for pre-operative confirmation and localization of kidney stones, offering advantages over X-rays by providing 3D localization and distinguishing between stones and tumors.

In a study involving 44 patients, the ultrasound technique successfully localized stones in 26 cases, demonstrating its potential utility in guiding minimally invasive procedures for stone removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ultrasonic examination in the treatment of renal calculi]. Lytton, B.[2006]

In a study of 100 patients, twinkling artifact (TA) on color Doppler ultrasound demonstrated high sensitivity (94%) and accuracy (94%) for detecting kidney stones smaller than 5 mm, making it a reliable diagnostic tool.

TA was found to be significantly more effective than traditional posterior acoustic shadowing in identifying small stones, suggesting that color Doppler ultrasound could serve as a safe alternative to non-contrast-enhanced CT for diagnosing urolithiasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation into the clinical accuracy of twinkling artifacts in patients with urolithiasis smaller than 5 mm in comparison with computed tomography scanning. Hanafi, MQ., Fakhrizadeh, A., Jaafaezadeh, E.[2022]

Ultrasound was able to detect renal stones in 93% of the 83 patients studied, but it only identified all stones in 60% of those cases, indicating some limitations in its accuracy.

KUB with tomograms (KUB/T) proved to be a more reliable method for assessing the size and number of small renal stones, particularly those measuring 2 mm or less, which were often missed by ultrasound.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of ultrasound in medical management of patients with renal stone disease. Vrtiska, TJ., Hattery, RR., King, BF., et al.[2022]

In a study of 210 patients with hydronephrosis, urinary stones were identified as the cause in 60% of cases, highlighting their significant role in this condition.

The detection rate of urinary stones increased with the severity of hydronephrosis, with rates of 50% for Grade 1, 61% for Grade 2, and 71.4% for Grade 3, but decreased in Grade 4, indicating a complex relationship between hydronephrosis severity and stone detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between grades of Hydronephrosis and detection of urinary stones by ultrasound imaging. Alshoabi, SA.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Innovations in Ultrasound Technology in the Management of Kidney Stones. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The efficacy of ultrasonography for the detection of renal stone. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Accuracy of sonography for detecting renal stone: comparison with CT. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Evaluation of the role of echography in the positive diagnosis of renal colic secondary to kidney stone]. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

The ability of renal ultrasound and ureteral jet evaluation to predict 30-day outcomes in patients with suspected nephrolithiasis. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Ultrasonic evaluation of renal calculi. [2008]

7. United States pubmed.ncbi.nlm.nih.gov

Stone-Mode Ultrasound for Determining Renal Stone Size. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Use of the Acoustic Shadow Width to Determine Kidney Stone Size with Ultrasound. [2022]

9. Pakistan pubmed.ncbi.nlm.nih.gov

Clinical predictors of an abnormal ultrasound in patients presenting with suspected nephrolithiasis. [2020]

10. Italy pubmed.ncbi.nlm.nih.gov

Detection rate of ultrasound vs CT scan in clinical staging accuracy of renal tumors pT1NxMx. [2016]

11. France pubmed.ncbi.nlm.nih.gov

[Ultrasonic examination in the treatment of renal calculi]. [2006]

12. India pubmed.ncbi.nlm.nih.gov

An investigation into the clinical accuracy of twinkling artifacts in patients with urolithiasis smaller than 5 mm in comparison with computed tomography scanning. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Role of ultrasound in medical management of patients with renal stone disease. [2022]

14. Pakistan pubmed.ncbi.nlm.nih.gov

Association between grades of Hydronephrosis and detection of urinary stones by ultrasound imaging. [2022]