Retrograde vs Antegrade Nephrostomy for Kidney Stones

Overseen By Amy Isidahomen

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Pyelonephritis, Prior procedure, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for treating kidney stones: antegrade nephrostomy and retrograde nephrostomy. The goal is to determine which method is more effective and identify patient characteristics that might predict success for each approach. It targets individuals with kidney stones larger than 10 mm in the kidney or upper ureter (the tube connecting the kidney to the bladder). Those with mid or lower ureter stones, kidney infections, or certain kidney conditions are not eligible. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially enhance treatment options for future patients.

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.

What prior data suggests that these nephrostomy techniques are safe for treating kidney stones?

Research has shown that retrograde nephrostomy, a method to access the kidney from below, is a safe and well-established procedure. It is often used to treat kidney stones and has proven both safe and effective. One study found it leads to fewer complications and is less stressful on the body compared to some other methods. Another analysis demonstrated its effectiveness in clearing stones.

For antegrade nephrostomy, which accesses the kidney from above, strong evidence also supports its safety. This method is commonly used for kidney stone procedures and is considered standard practice. Both methods have their own benefits and risks, but studies generally support their safety in patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing retrograde and antegrade nephrostomy techniques for kidney stone removal because these methods offer different approaches to accessing the kidney. Retrograde nephrostomy is unique because it involves accessing the kidney through the ureter, which might be less invasive and allow for quicker recovery times. In contrast, antegrade nephrostomy involves accessing the kidney directly through the skin, which can provide a more direct path to large or complex stones. By comparing these methods, researchers hope to determine which technique offers better outcomes in terms of effectiveness, recovery, and patient comfort.

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

Research has shown that retrograde nephrostomy, one of the treatment options in this trial, can effectively treat kidney stones. A review of studies found that this method clears stones more successfully, particularly for stones measuring 1-3 cm. Another study found that retrograde procedures resulted in more patients being stone-free after treatment compared to other methods. Additionally, these procedures often require fewer follow-up treatments and have shorter surgery times. This evidence suggests that retrograde nephrostomy could be a strong option for effectively treating kidney stones. Meanwhile, the trial will also evaluate antegrade nephrostomy, the control group treatment, to compare its effectiveness and outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Nadeem N Dhanani, MD,MPH

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals with large kidney stones (>10 mm) located in the renal pelvis or upper ureter, as confirmed by CT scans. It's not suitable for those who've had previous stone removal from the same kidney, have a current kidney infection, are pregnant, or have an abnormally shaped kidney like Horseshoe or Ectopic kidneys.

Inclusion Criteria

I have kidney stones larger than 10 mm in my renal pelvis or ureter.

Exclusion Criteria

I have an abnormal kidney shape or position.

I am suspected to have a kidney infection.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo percutaneous nephrostomy for urolithiasis treatment using either retrograde or antegrade approach

1 day

1 visit (in-person)

Follow-up

Participants are monitored for stone-free status and normal laboratory values

6-12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Antegrade Nephrostomy
• Retrograde Nephrostomy

Trial Overview The study compares two techniques of creating a channel to reach and remove kidney stones: one where access is made going backwards (retrograde) into the urinary system versus another where access is made going forwards (antegrade). The goal is to see which method leads to better outcomes.

How Is the Trial Designed?

Group I: Treatment (retrograde nephrostomy) Experimental Treatment 1 Intervention

Group II: Control Group ( antegrade nephrostomy) Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37875837/

a systematic review and meta-analysis of 18 randomized ... The meta-analysis revealed that mPCNL of 1-2 cm or 2-3 cm stones had a higher stone clearance rate (RR:1.08, 95%CI (1.03, 1.14), p = 0.002) and shorter ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07071831

RETRO Study (RETrograde Renal Access Outcomes) The goal of this observational study is to learn about the benefit of using RetroPerc® in obtaining renal access for percutaneous ...

3. link.springer.com link.springer.com/article/10.1007/s00345-025-05689-z

Flexible mini-percutaneous nephrolithotomy versus ... F-mPCNL showed a superior SFR in treating renal stones compared to RIRS in a single session, with less need for auxiliary procedures, shorter operative time, ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/ijcp.14956

Comparison of percutaneous nephrolithotomy and ... To compare surgical outcomes of percutaneous nephrolithotomy (PNL) and retrograde intrarenal surgeries (RIRS) as a result of kidney stones larger than 2 cm.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8991168/

Effectiveness and safety of retrograde intrarenal surgery ... Retrograde intrarenal surgery (RIRS) has been reported to be an effective treatment for renal and ureteral stones < 2 cm, with fewer complications and more ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/17562872241241854

Meta-analysis of perioperative outcomes and safety ... Our meta-analysis found PCN performed better than RUS in hematuria and catheterization failure rate, although PCN was associated with longer exposure time.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1743919119302328?dgcid=rss_sd_all#!

Review Minimally invasive percutaneous nephrolithotomy ... The purpose of this study was to retrospectively assess the efficacy and safety of minimally invasive nephrolithotomy (MPCNL) versus retrograde intrarenal ...