Miniaturized Percutaneous Nephrolithotomy for Kidney Stones

Recruiting in Palo Alto (17 mi)

Overseen by Sriharan Sivalingam

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Cleveland Clinic

Must not be taking: Anticoagulants

Disqualifiers: Coagulopathy, Renal anomalies, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on blood thinners (anticoagulants), you may not be eligible to participate.

What data supports the effectiveness of the treatment Miniaturized Percutaneous Nephrolithotomy for Kidney Stones?

Research shows that miniaturized percutaneous nephrolithotomy (mini-PCNL) is effective for removing kidney stones while reducing complications compared to the standard procedure. The use of vacuum-assisted access sheaths in mini-PCNL has been introduced as a new method to enhance the treatment's effectiveness.

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Is miniaturized percutaneous nephrolithotomy generally safe for humans?

Research shows that miniaturized percutaneous nephrolithotomy (mini-PCNL) is generally safe for removing kidney stones, with studies comparing different sheath sizes and techniques indicating good safety profiles in both adults and children.

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How is miniaturized percutaneous nephrolithotomy different from other treatments for kidney stones?

Miniaturized percutaneous nephrolithotomy (PCNL) uses smaller sheaths compared to conventional PCNL, which reduces the risk of complications and improves recovery while maintaining effectiveness in removing kidney stones.

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Eligibility Criteria

This trial is for adults over 18 with kidney stones sized between 10-25 mm, who can consent and meet study requirements. It's open to all ethnicities and genders. Those with a nephrostomy tube or ureteral stent already in place may join. People on blood thinners, with coagulation disorders, congenital kidney anomalies, previous kidney surgeries, or needing multiple access tracts are excluded.

Inclusion Criteria

I am scheduled for a specific kidney stone surgery and had a special CT scan before.

I am willing and able to follow the study's requirements.

I am 18 years old or older.

Exclusion Criteria

I have had surgery before on the same side of my upper urinary tract.

I am able to understand and agree to the study's requirements.

My surgery was changed to an open procedure.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo miniaturized percutaneous nephrolithotomy using either a vacuum-assisted or standard sheath

1 day

1 visit (in-person)

Post-operative Hospital Stay

Participants remain in the hospital for recovery and monitoring after the procedure

1-2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up appointment approximately 4-6 weeks post-surgery

4-6 weeks

1 visit (in-person)

Participant Groups

The study compares two surgical methods for removing kidney stones: one using a vacuum-assisted sheath and the other using a conventional sheath during mini-PCNL (a minimally invasive surgery). The goal is to determine which method is more effective for patients like you.

Group I: passive suction via conventional sheath Active Control 2 Interventions

Group II: vacuum-assisted sheath Active Control 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cleveland Clinic Cleveland, OH

Who Is Running the Clinical Trial?

The Cleveland Clinic Lead Sponsor

References

1. Spain pubmed.ncbi.nlm.nih.gov

Vacuum-assisted access sheath in supine mini-percutaneous nephrolithotomy (mini-PCNL). [2023] The vacuum-assisted access sheath is a new device for the treatment of kidney stones with percutaneous nephrolithotomy (PCNL).

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

Mini-percutaneous nephrolithotomy. [2016] Standard percutaneous nephrolithotomy is highly effective for the removal of renal calculi. However, significant morbidity has been associated with this procedure. Consequently, many urologists inappropriately defer to a less effective procedure to reduce patient morbidity. This practice may increase the total number of procedures needed for treatment and result in a substantial increase in health care costs. Mini-percutaneous nephrolithotomy using a 13F ureteroscopy sheath is described to reduce the morbidity associated with standard percutaneous nephrolithotomy while maintaining its efficiency and effectiveness for stone removal. The indications and technique for mini-percutaneous nephrolithotomy and our results are summarized.

3. Switzerland pubmed.ncbi.nlm.nih.gov

Mini-Perc for Renal Stones-A Single Center Experience and Literature Review. [2023] The aim of this study was to analyze the outcomes of miniaturized nephrolithotomy (mini-perc) in the management of renal stones with a diameter smaller than 20 mm.

4. Italy pubmed.ncbi.nlm.nih.gov

Updated evidence of the safety and efficacy of the miniaturized percutaneous nephrolithotomy with holmium laser lithotripsy for the treatment of recurrent nephrolithiasis. [2022] The objective of the present communication is to report the safety and efficacy of applying miniaturized percutaneous nephrolithotomy (mini-PCNL) in Vietnamese patients with recurrent kidney stones using a miniature nephroscope through a 18F metal access sheath.

5. Singapore pubmed.ncbi.nlm.nih.gov

Mini versus ultra-mini percutaneous nephrolithotomy in a paediatric population. [2022] To evaluate whether there would be a difference in outcome when the smaller ultra-mini 12 Fr sheath was used instead of the mini 16 Fr sheath for percutaneous nephrolithotomy (PCNL) in paediatric patients for stones less than 25 mm.

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

Minipercutaneous nephrolithotomy. [2022] To evaluate the safety and efficacy of a minipercutaneous nephrolithotomy procedure (mini-PCNL) through a 20F sheath.

7. England pubmed.ncbi.nlm.nih.gov

Comparison of vacuum-assisted sheaths and normal sheaths in minimally invasive percutaneous nephrolithotomy: a systematic review and meta-analysis. [2022] A systematic review and meta-analysis was conducted to compare the safety and efficacy of vacuum-assisted sheaths and conventional sheaths in minimally invasive percutaneous nephrolithotomy (MPCNL) in the treatment of nephrolithiasis.

8. Germany pubmed.ncbi.nlm.nih.gov

Comparison between standard, mini and ultra-mini percutaneous nephrolithotomy for single renal stones: a prospective study. [2022] Based on the current trend of miniaturization of instruments used in percutaneous nephrolithotomy (PCNL), it is necessary to compare different PCNL modalities regarding their access sheath size used. Thus, the safety and efficacy among standard, mini and ultra-mini PCNL (s-PCNL, m-PCNL, um-PCNL) were compared.

9. Korea (South) pubmed.ncbi.nlm.nih.gov

The "mini-perc" technique of percutaneous nephrolithotomy with a 14-Fr peel-away sheath: 3-year results in 72 patients. [2018] To assess the efficacy and safety of a "mini-perc" technique of percutaneous nephrolithotomy using a 14-Fr peel-away sheath for the removal of pyelocaliceal stones, and to determine appropriate inclusion criteria.

10. India pubmed.ncbi.nlm.nih.gov

Ultra-mini-percutaneous nephrolithotomy: A minimally-invasive option for percutaneous stone removal. [2022] Percutaneous nephrolithotomy (PCNL) has witnessed rapid advancements, the latest being ultra-mini-percutaneous nephrolithotomy (UMP), which makes the use of 11-13F sheaths as compared to 24-30F sizes used in conventional PCNL. This miniaturization aims to reduce morbidity and improve patient outcomes. We evaluated the safety and efficacy of UMP and report our ourtcomes.

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

Precision Stone Surgery: Current Status of Miniaturized Percutaneous Nephrolithotomy. [2021] Innovations in lasers and surgical technology have led to a renewed interest in the miniaturization of percutaneous nephrolithotomy (PCNL). We review the different approaches and evidence on the efficacy of mini-PCNL.