Standard vs Mini-PCNL for Kidney Stones

Overseen By Naveen Kachroo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must not be taking: Anticoagulants

Disqualifiers: Coagulopathy, Ureteral stent, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of performing Percutaneous Nephrolithotomy (PCNL), a procedure for removing kidney stones. One method is the standard PCNL, while the other is a smaller version called mini-PCNL. The trial aims to determine which method aids better patient recovery. Suitable participants are those with kidney stones between 10-20mm who are already planning to undergo a PCNL procedure. As an unphased trial, it provides patients the chance to contribute to medical knowledge and potentially benefit from innovative treatment options.

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

The trial information does not specify if you need to stop taking your current medications. However, if you are on blood thinners or have a history of bleeding disorders, you may not be eligible to participate.

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

Research has shown that both mini-PCNL and standard PCNL are generally safe for removing kidney stones. Mini-PCNL effectively treats medium-sized stones and is well-tolerated by patients. One study found that mini-PCNL manages kidney stones safely with good results, and complications are rare, making it a reliable option.

For standard PCNL, research indicates a low complication rate of 3.6%. This procedure effectively treats larger kidney stones and is generally safe. Overall, evidence supports that both treatments are effective and well-tolerated for removing kidney stones. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two different approaches to percutaneous nephrolithotomy (PCNL) for kidney stones: the standard PCNL and the mini-PCNL. The mini-PCNL uses a smaller, 16 fr tract compared to the standard 24 fr tract, which could mean less tissue disruption and potentially quicker recovery times for patients. By assessing these differences, researchers aim to determine whether the mini-PCNL can offer similar or improved outcomes with fewer complications, making it a potentially better option for those suffering from kidney stones.

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

This trial will compare the effectiveness of standard PCNL and mini-PCNL for treating kidney stones. Research has shown that both standard PCNL and mini-PCNL effectively treat kidney stones. Specifically, studies found that standard PCNL can make up to 90.4% of patients stone-free after a second procedure, particularly excelling with larger stones by clearing 94% of stones over 15 mm. Mini-PCNL, which participants in this trial may receive, is equally effective and safe as the standard method. It typically requires less time to perform, though patients might experience a longer hospital stay. Both procedures successfully remove stones, with only slight differences in hospital stay and recovery time. ^{5 6 7 8 9}

Who Is on the Research Team?

Manoj Monga, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent to participate, are scheduled for PCNL (a procedure to remove kidney stones) at certain hospitals, and have a stone size of 10-20mm. It's open to all genders and ethnicities. Those with multiple access tracts, preoperative stents or tubes, coagulation issues, or unable to give consent are excluded.

Inclusion Criteria

I am either male or female.

I am able to understand and agree to participate in the study.

You have kidney stones that are between 10 and 20 millimeters in size.

Exclusion Criteria

I am on blood thinners or have a history of bleeding disorders.

Having more than one entry point.

My surgery was changed to an open procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either mini-PCNL or standard PCNL procedure

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for blood loss and inflammatory markers post-surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for complications and surgical outcomes

30 days

What Are the Treatments Tested in This Trial?

Interventions

• PCNL

Trial Overview The study compares standard PCNL versus mini-PCNL in terms of patient outcomes. Participants will be randomly assigned to receive either the standard or the smaller-scale version of this kidney stone removal procedure.

How Is the Trial Designed?

Group I: Mini-PCNL Active Control 1 Intervention

Patients receive a mini-PCNL procedure using a 16 fr tract

Group II: Standard PCNL Active Control 1 Intervention

Patients receive a standard PCNL procedure using a 24 fr tract

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Miniaturized percutaneous nephrolithotomy (mPCNL) showed a higher stone-free rate (SFR) compared to standard PCNL (sPCNL) in a study of 1,219 patients, indicating it may be more effective for treating kidney stones.

mPCNL was associated with lower transfusion rates and less bleeding, making it a safer option, although it required a longer operative time compared to sPCNL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of miniaturized percutaneous nephrolithotomy versus standard percutaneous nephrolithotomy: A systematic review and meta-analysis of randomized controlled trials. Feng, D., Hu, X., Tang, Y., et al.[2021]

Mini-PNL (mini-percutaneous nephrolithotomy) is a safe and effective treatment for kidney stones in infants under 3 years old, achieving an impressive stone-free rate of 84.7% one month post-surgery based on a study of 74 patients.

The procedure had a low complication rate, with no major complications observed, and involved a mean operative time of 74 minutes and an average hospital stay of 3.8 days, indicating it is a viable option for managing kidney stones in this young age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of miniaturized percutaneous nephrolitotomy in infants: single centre experience. Pelit, ES., Kati, B., Çanakci, C., et al.[2022]

Mini PCNL (mPCNL) resulted in significantly less blood loss and shorter hospital stays compared to standard PCNL (sPCNL), making it a safer option for patients undergoing kidney stone removal.

While the stone-free rate was slightly higher for sPCNL (69.4%) compared to mPCNL (62.7%), both techniques were effective, indicating that mPCNL offers a favorable balance of safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kidney stone management in the era of miniaturized percutaneous nephrolithotomy: does it improve safety? a prospective cohort study. Sakly, A., Zakhama, W., Jleli, N., et al.[2023]

Mini-percutaneous nephrolithotomy (Mini-PNL) resulted in significantly lower stone-free rates (SFR) compared to standard-PNL (89.9% vs 96%), particularly for patients with multiple stones or larger stone burdens (>2 cm²).

However, Mini-PNL was associated with significantly fewer complications (7.9% vs 20.5%) and shorter hospital stays (2.43 days vs 4.29 days), making it a safer option despite the lower SFR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini vs standard percutaneous nephrolithotomy for renal stones: a comparative study. ElSheemy, MS., Elmarakbi, AA., Hytham, M., et al.[2020]

The prevalence of renal stone disease is increasing globally, leading to more surgical interventions, particularly with advancements in technology that reduce complications and hospital stays.

This review focuses on comparing outcomes of various percutaneous nephrolithotomy techniques using instruments smaller than 12Fr, highlighting the need to evaluate the effectiveness and safety of these minimally invasive approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome-Based Comparison of Percutaneous Procedures for Urinary Lithiasis with Calibre of Instrumentation less than 12Fr. Wells, H., Rukin, N., Wright, A., et al.[2018]

Mini-PCNL, a miniaturized version of conventional percutaneous nephrolithotomy (PCNL), offers a lower morbidity rate while maintaining an equal stone-free rate, making it a safer option for patients with upper urinary tract stones larger than 10 mm.

The technique utilizes irrigation flow to remove stones without the need for forceps or baskets, indicating a different mechanism of action compared to traditional methods, and it is now widely adopted as a treatment alternative to flexible ureterorenoscopy and SWL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Miniaturisation of PCNL. Lahme, S.[2022]

Mini-PCNL is an effective treatment for lower pole renal stones (≤20mm) that do not respond to extracorporeal shock wave lithotripsy (ESWL), achieving a high stone-free rate of 90% in a study of 42 patients.

The procedure has a manageable overall complication rate of 26%, with most complications being minor, indicating that mini-PCNL is a safe option for patients with these types of kidney stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of ultrasound-guided mini-percutaneous nephrolithotomy for ESWL-resistant lower calyx renal stones of up to two centimeters: a single center experience. Sabhan, AH., Alwan, AAA.[2023]

Mini-PCNL is an effective procedure for removing larger kidney stones and those that are difficult to access, utilizing a minimally invasive approach with a small incision and advanced imaging techniques.

Preliminary evidence suggests that mini-PCNL may have lower transfusion rates compared to standard PCNL and potentially higher stone-free rates than ureteroscopy for lower pole stones, although more randomized trials are needed for definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Surgical Technique of Mini Percutaneous Nephrolithotomy. Sadiq, AS., Atallah, W., Khusid, J., et al.[2021]

Mini-PCNL is a safe and effective treatment for kidney stones sized 2-4 cm, showing fewer intra-operative complications and a shorter hospital stay compared to standard-PCNL, based on a study of 80 patients.

While the stone-free rates were similar (80% for mini-PCNL vs. 85% for standard-PCNL), mini-PCNL required less post-operative analgesia and had a longer mean operative time (95 min vs. 72 min for standard-PCNL).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concerns about stone free rate and procedure events of percutaneous nephrolithotripsy (PCNL) for 2-4 cm kidney stones by standard-PCNL vs mini-PCNL- comparative randomised study. Wishahi, M., El Feel, A., Elkhouly, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4374249/

Mini percutaneous nephrolithotomy in the treatment of ... Mini-PCNL can achieve comparable stone-free rates to the conventional method, even for large stones. It is a safe procedure, and no major complications are ...

2. 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.

3. journals.lww.com journals.lww.com/ursc/fulltext/2022/33030/comparison_between_tubeless_mini_percutaneous.9.aspx

Comparison between Tubeless Mini-Percutaneous... Tubeless mini-PCNL compared to RIRS offers the better outcome of higher stone-free rate and lower operation time, but with longer hospital stay and stone-free ...

4. bmcurol.biomedcentral.com bmcurol.biomedcentral.com/articles/10.1186/s12894-024-01588-4

a systematic review and meta-analysis | BMC Urology Our study showed that MiniPCNL in obese patients had higher initial SFR and final SFR, fewer procedures, but more postoperative complications, LOS, and grade I ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835507

Percutaneous Nephrolithotomy vs Ureteroscopy for Kidney ... This cohort study compares the outcomes associated with use of percutaneous nephrolithotomy vs ureteroscopy for clearance of kidney stones ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11477521/

Safety and efficacy of ambulatory tubeless mini ... Ambulatory tubeless mini-PCNL is a safe and effective treatment option for 10–25 mm renal stones. Experienced institutions can safely adopt ambulatory mini-PCNL ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12465242/

Safety and efficacy of total tubeless mini-PCNL in the ... Safety and efficacy of total tubeless mini-PCNL in the management of renal stones: prospective observational study · Abstract. Introduction.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1166708723002129

Mini-percutaneous nephrolithotomy: Is smaller better for ... In our study, mPCNL was associated with good outcomes in patients with NLUTD. The 3-month SFR achieved with mPCNL (37.5%) was comparable to that of sPCNL (38.2 ...

9. nature.com nature.com/articles/s41598-025-99087-5

Comparison of mini-percutaneous nephrolithotomy and ... The data of 320 patients with renal calculi and an eGFR < 60 mL ... MPCNL and SPCNL are safe and effective for managing patients with kidney ...