Dusting vs. Basket Extraction for Kidney Stones and Ureter Stones

Overseen By Mark Assmus, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Solitary kidney, Nephrocalcinosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for treating kidney and ureter stones that are 6 mm or larger. One method, called "dusting" (a type of laser lithotripsy), uses a laser to break the stone into tiny pieces to pass naturally. The other method, known as "basket extraction," uses a wire basket to remove the fragments. Researchers aim to determine which method leads to better results, fewer side effects, and higher patient satisfaction. Individuals with kidney or ureter stones of at least 6 mm who are considering ureteroscopic treatment might be suitable candidates. As an unphased trial, this study allows patients to contribute to medical knowledge and potentially benefit from innovative treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using lasers to treat kidney stones is generally safe and effective. The Moses 2.0 laser system, in particular, breaks down stones faster and with less movement, reducing the chance of side effects and complications.

For removing stones with a basket, studies indicate it is safe and well-tolerated by most people. However, issues with the device used to grab the stones can occur, though these are rare.

Both laser and basket methods have been tested in various studies and are considered safe options for treating kidney stones. Those considering these treatments can generally feel confident about their safety based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the dusting and basketing techniques for kidney and ureter stones because they offer potentially less invasive options compared to traditional methods like percutaneous nephrolithotomy or shock wave lithotripsy. The dusting technique uses a Moses laser to break stones into tiny fragments, which can pass naturally, reducing the need for extensive removal procedures. The basketing approach allows for the complete extraction of stone fragments through a ureteral access sheath, potentially minimizing the risk of leaving residual stones. Both methods aim to reduce the trauma to the ureter and eliminate the need for post-procedure stenting if no injury is detected, which could lead to faster recovery times and less discomfort for patients.

What evidence suggests that this trial's treatments could be effective for kidney and ureter stones?

This trial compares two methods for treating kidney and ureter stones: dusting and basket extraction. In the "dusting" arm, a laser breaks the stones into tiny pieces that can pass naturally. Research indicates that Moses laser technology in dusting speeds up the process and breaks stones more efficiently. In the "basketing" arm, a small wire basket removes the stone pieces. One study found that this method successfully removed all stones in 91% of patients. Both methods offer advantages: dusting is quicker, while basket extraction has a high rate of complete stone removal. ^{6 7 8 9 10}

Who Is on the Research Team?

Amy Krambeck, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with kidney or ureteral stones at least 6mm large, who are undergoing a specific stone removal procedure and can consent to the study. It's not for those under 18, with only one kidney, certain kidney conditions, without phone access, needing additional surgeries, or in vulnerable groups.

Inclusion Criteria

Willing to sign informed consent form

I have a kidney stone that is 6mm or larger, located in the middle or upper part of my ureter.

Able to read, understand, and complete patient questionnaires and pain questionnaires

Exclusion Criteria

I have only one kidney.

I have been diagnosed with nephrocalcinosis.

Inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ureteroscopic treatment with either high-powered laser dusting or low power laser fragmentation and basketing

1 day

1 visit (in-person)

Post-surgery Monitoring

Participants complete a pain assessment questionnaire in the outpatient recovery area and receive daily emails or text messages to assess pain and daily activities until pain resolves

Up to 6 weeks

Follow-up

Participants undergo an ultrasound 6 weeks after surgery and return to the urology clinic 12 weeks after surgery for a follow-up visit including renal bladder ultrasound and kidney ureter bladder abdominal x-ray

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Basket extraction
• Dusting

Trial Overview The study compares two methods of removing kidney and ureteral stones: 'dusting' using a laser to break down stones so they pass in urine versus 'basket extraction' where fragments are physically removed with a wire basket.

How Is the Trial Designed?

Group I: laser dusting Active Control 1 Intervention

In the "dusting" arm, the ureteroscope will be advanced into the kidney or ureter over an access wire without an access sheath in place. The identified stone will be dusted using a 200 micron Moses laser fiber at a setting of 0.3-0.6 J and 50-120 Hz using the Moses 2.0 laser system. Stone dusting will continue until the surgeon feels the fragments are all negligible in size and would be able to pass. One small piece will be extracted for analysis and the remainder will be left to pass spontaneously. If there is no evidence of injury or swelling of the ureter at the conclusion of the case a stent will be omitted.

Group II: basketing Active Control 1 Intervention

In the Basketing arm, a ureteral access sheath (UAS) will be placed per standard fashion. The ureteroscope will be introduced into the kidney and the stone fragmented at a setting of 0.8-1.0 J and 6-15 Hz. The resultant fragments will be basket extracted through the sheath for analysis. All fragments will be removed until no residual stone remains. At the time of UAS removal the ureter will be inspected. If there is no evidence of ureteral injury or swelling then a stent will be omitted.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8648003/

Efficacy of one-surgeon basketing technique for stone ... Results: Among our study population, the median stone size was 14 mm and median operative time was 74 min. A stone-free status was achieved in 91 patients (91%) ...

2. europeanreview.org europeanreview.org/wp/wp-content/uploads/3430-3436.pdf

Retrospective analysis of stone basket combined with ... Studies1-3 have shown that 25-36% of kidney stones are lower calyceal stones (LCS), and about 40% of cases with LCS show clinical symptoms that require ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S266616832100001X

Stone Disease Effectiveness of Flexible Ureterorenoscopy ... In patients treated by URS, successful primary ureteral access was achieved in 20 patients (87%), and the mean operating time was 79 ± 33 min. Three patients ( ...

4. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003397

Data From a Prospective, Randomized Clinical Trial We evaluate the outcomes of ureteroscopy vs prone mini-percutaneous nephrolithotomy for 1-2–cm renal stones using a 2-group parallel randomized control trial.

5. jurolsurgery.org jurolsurgery.org/articles/effectiveness-of-second-look-flexible-ureteroscopy-to-achieve-a-true-stone-free-status-in-retrograde-intrarenal-surgery/jus.galenos.2021.2021.0092

Effectiveness of Second-look Flexible Ureteroscopy to ... Second-look flexible ureterorenoscopy increased the stone-free rates and diminished the number of stone-related events. We argue that performing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11666679/

evaluation of safety, tolerance and feasibility of magnetic ... This method has the potential to increase stone-clearance rates with shorter extraction times, offering a possibility for addressing the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9422793/

Initial Safety and Feasibility of Steerable Ureteroscopic ... This initial study suggests SURE is safe, feasible, and may be more effective in stone removal postlaser lithotripsy compared to basketing.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022534710045325

Complications of Stone Baskets: 14-Year Review of the ... We identified 556 adverse events related to stone baskets. The device configuration was tipped in 48% of cases, tipless in 36%, forceps in 8% and the Stone Cone ...

9. uroweb.org uroweb.org/guidelines/urolithiasis/chapter/guidelines

EAU Guidelines on Urolithiasis Previous stone history (recurrence, regrowth, stone surgeries) is a fundamental element in determining risk for stone formation. About 50% of recurrent stone ...

10. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/kidney-stones

Kidney Stones Clinical Trials The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to ...