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

Trial Summary

What is the purpose of this trial?

Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.

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.

What data supports the effectiveness of the treatment PCNL for kidney stones?

Research shows that both standard and mini-PCNL are effective for removing kidney stones, with standard PCNL having a slightly higher stone-free rate but more complications. Mini-PCNL offers a shorter hospital stay and fewer complications, making it a good option for many patients. ^{1 2 3 4 5}

Is mini-PCNL safer than standard PCNL for kidney stones?

Mini-PCNL generally has fewer complications and a shorter hospital stay compared to standard PCNL, making it a safer option for treating kidney stones. ^{2 3 6 7 8}

How does the treatment Mini-PCNL differ from other treatments for kidney stones?

Mini-PCNL is a smaller version of the standard percutaneous nephrolithotomy (PCNL) that uses a smaller incision and instruments, leading to fewer complications and a shorter hospital stay, although it may have a slightly lower stone-free rate for larger or multiple stones compared to standard PCNL. It is particularly useful for stones that are not responsive to other treatments like shockwave therapy and offers a less invasive option with reduced recovery time. ^{2 3 4 5 9}

Research Team

Manoj Monga, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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-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]

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]

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, 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]

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-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]

References

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

Outcome-Based Comparison of Percutaneous Procedures for Urinary Lithiasis with Calibre of Instrumentation less than 12Fr. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Mini vs standard percutaneous nephrolithotomy for renal stones: a comparative study. [2020]

3. England 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. [2023]

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

The Surgical Technique of Mini Percutaneous Nephrolithotomy. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Miniaturisation of PCNL. [2022]

6. Korea (South) 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. [2021]

7. Brazil pubmed.ncbi.nlm.nih.gov

Outcomes of miniaturized percutaneous nephrolitotomy in infants: single centre experience. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Kidney stone management in the era of miniaturized percutaneous nephrolithotomy: does it improve safety? a prospective cohort study. [2023]

9. Romania 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. [2023]