Standard vs Mini-PCNL for Kidney Stones
Recruiting in Palo Alto (17 mi)
Overseen byManoj Monga, MD
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, Ureteral stent, others
No Placebo Group
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.
12345Is 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.
23678How 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.
23459Eligibility 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.
+3 more
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.
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Group I: Mini-PCNLActive Control1 Intervention
Patients receive a mini-PCNL procedure using a 16 fr tract
Group II: Standard PCNLActive Control1 Intervention
Patients receive a standard PCNL procedure using a 24 fr tract
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland Clinic FoundationCleveland, OH
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Who Is Running the Clinical Trial?
The Cleveland ClinicLead Sponsor
Vanderbilt University Medical CenterCollaborator
Duke UniversityCollaborator
Dartmouth-Hitchcock Medical CenterCollaborator
Ohio State UniversityCollaborator
Columbia UniversityCollaborator
University of British ColumbiaCollaborator
Massachusetts General HospitalCollaborator
References
Outcome-Based Comparison of Percutaneous Procedures for Urinary Lithiasis with Calibre of Instrumentation less than 12Fr. [2018]Renal stone disease is becoming increasingly prevalent globally. With a rise in stone disease worldwide, there is also a relative increase in the rates of surgical intervention. Technological advances have allowed a move towards minimising the complications rates and length of stay with a reduction in invasiveness and size of instruments. A trend for minimising the percutaneous tract size has been noted in percutaneous nephrolithotomy (PCNL) for renal stones. The management has shifted from open surgery to standard PCNL, mini-PCNL and the latest ultra-mini and micro-PCNL techniques. There is a need to compare outcomes for the ever-advancing technologies, such as the smaller calibre of instruments, to assess risk-benefit in practice. This review looks at outcome-based comparison of percutaneous procedures for urinary lithiasis with instruments
Mini vs standard percutaneous nephrolithotomy for renal stones: a comparative study. [2020]To compare the outcome of mini-percutaneous nephrolithotomy (Mini-PNL) versus standard-PNL for renal stones. Retrospective study was performed between March 2010 and May 2013 for patients treated by Mini-PNL or standard-PNL through 18 and 30 Fr tracts, respectively, using pneumatic lithotripsy. Semirigid ureteroscope (8.5/11.5 Fr) was used for Mini-PNL and 24 Fr nephroscope for standard-PNL. Both groups were compared in stone free rate(SFR), complications and operative time using Student-t, Mann-Whitney, Chi square or Fisher's exact tests as appropriate in addition to logistic regression analysis. P < 0.05 was considered statistically significant. Mini-PNL (378) and standard-PNL (151) were nearly comparable in patients and stones criteria including stone burden (3.77 ± 2.21 vs 3.77 ± 2.43 cm2; respectively). There was no significant difference in number of tracts or supracostal puncture. Mini-PNL had longer operative time (68.6 ± 29.09 vs 60.49 ± 11.38 min; p = 0.434), significantly shorter hospital stay (2.43 ± 1.46 vs 4.29 ± 1.28 days) and significantly higher rate of tubeless PNL (75.1 vs 4.6%). Complications were significantly higher in standard-PNL (7.9 vs 20.5%; p < 0.001). SFR was significantly lower in Mini-PNL (89.9 vs 96%; p = 0.022). This significant difference was found with multiple stones and large stone burden (> 2 cm2), but the SFR was comparable between both groups with single stone or stone burden ≤ 2 cm. Logistic regression analysis confirmed significantly higher complications and SFR with standard-PNL but with significantly shorter operative time. Mini-PNL has significantly lower SFR when compared to standard-PNL (but clinically comparable) with markedly reduced complications and hospital stay. Most of cases can be performed tubeless. The significant difference in SFR was found with multiple stones or large stone burden (> 2 cm2), but not with single stones or stone burden ≤ 2 cm2.
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]To compare the efficacy and safety of standard percutaneous nephrolithotomy (PCNL) with mini- PCNL for kidney stones 2-4 cm.
The Surgical Technique of Mini Percutaneous Nephrolithotomy. [2021]The mini percutaneous nephrolithotomy (mini-PCNL) has become a versatile tool to remove kidney stones >2 cm, lower pole stones >1 cm, renal stones previously unresponsive to shockwave therapy or inaccessible by ureteroscopy (within a caliceal diverticulum), stones within complex urinary tracts (urinary diversions, transplanted kidney, and horseshoe kidneys), and large impacted proximal ureteral stones. After positioning in either the supine or prone position, a cystoscopy is performed to place an open-ended catheter, occlusion balloon, or Accordian device into the collecting system. A foley catheter is placed in the bladder. An ultrasound with a curvilinear probe is used to survey the kidney and guide access into the collecting system with an 18 g percutaneous needle. Once access is obtained, a small 0.5 cm skin incision is made and the percutaneous tract is dilated over a wire. A 16.5F metallic or self-dilating suctioning access sheath is positioned with fluoroscopic guidance. A 12F rigid mini-PCNL nephroscope is used to evaluate the collecting system. Once a calculus is observed, options for stone fragmentation include a lithotripter with ultrasonic and ballistic energy, or laser lithotripsy using holmium or thulium laser fibers. Flexible ureteroscopy can be considered to ensure clearance of the collecting system. A 6F ureteral stent can be placed in either a retrograde or antegrade approach for drainage. The tract is sealed using Surgiflo hemostatic matrix with thrombin. Guidelines for postoperative care and troubleshooting techniques for mini-PCNL are reviewed along with the surgical steps in the accompanying video (Supplementary Video S1). There are few randomized trials comparing mini-PCNL with standard PCNL and ureteroscopy. There is some evidence to suggest a difference in transfusion rates comparing mini- and standard PCNL, as well as differences in stone-free rates when comparing mini-PCNL with ureteroscopy for the treatment of lower pole stones.
Miniaturisation of PCNL. [2022]Conventional PCNL leads to a high stone-free rate but is associated with a significant treatment morbidity. To decrease the morbidity of PCNL but to achieve an equal stone-free rate, in 2001 a miniaturised version of a conventional PCNL (Mini-PCNL) was introduced. Meanwhile numerous modifications of the Mini-PCNL were reported. The ongoing experience with the Mini-PCNL technique showed that Mini-PCNL is not only a miniaturisation but also a different method to remove the stones, as the stones come out of the calyceal system only by means of the irrigation flow without any further need of forceps or baskets. Due to a limited number of papers in the literature, the guidelines so far do not distinguish between conventional and Mini-PCNL, although the Mini-PCNL already became a frequent treatment modality in daily routine worldwide. From the current point of view, Mini-PCNL can be recommended to treat all kinds of upper urinary tract stones exceeding a diameter of 10 mm. In this context, Mini-PCNL is a treatment alternative to flexible ureterorenoscopy, SWL and conventional PCNL. The available literature shows that the morbidity of Mini-PCNL is less and the stone-free rate is equal to that of conventional PCNL. It seems that there is no limitation to Mini-PCNL in the treatment of upper urinary tract stones. The future will show what kind of further miniaturisation of the Mini-PCNL procedure will be appropriate.
The efficacy and safety of miniaturized percutaneous nephrolithotomy versus standard percutaneous nephrolithotomy: A systematic review and meta-analysis of randomized controlled trials. [2021]Our aim was to assess the efficacy and safety of miniaturized percutaneous nephrolithotomy (mPCNL) versus standard PCNL (sPCNL) to provide higher-level evidence.
Outcomes of miniaturized percutaneous nephrolitotomy in infants: single centre experience. [2022]The present study was aim to evaluate the safety and efficacy of Mini-PNL to treat kidney stones in patients aged
Kidney stone management in the era of miniaturized percutaneous nephrolithotomy: does it improve safety? a prospective cohort study. [2023]to compare the safety and the efficacy of standard percutaneous nephrolithotomy (sPCNL) vs. mini PCNL (mPCNL).
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]Lower pole renal stones present a significant challenge in urologic practice due to difficulty in accessing the calyx and eliminating fragments. Management options for these stones include watchful waiting for asymptomatic stones, extracorporeal shock wave lithotripsy (ESWL), ureterorenoscopy (URS), and percutaneous nephrolithotomy (PCNL). Mini-PCNL is a newer modification of conventional PCNL. The study aimed to assess the feasibility of mini-PCNL in treating lower pole renal stones equal to or less than 20mm that were not responsive to ESWL therapy. We included 42 patients (24 male and 18 female) with a mean age of 40±2.3 who underwent mini-PCNL at a single urology center between June 2020 and July 2022 and assessed operative and postoperative outcomes. The mean total operative time was 47±3.11 minutes, ranging from 40 to 60 minutes. The stone-free rate was 90%, and the overall complication rate was 26%, which included minor bleeding (5%), hematuria (7%), pain (12%), and fever (2%). The mean hospital stay was 80±3.34 hours (3-4 days). Our findings suggest that mini-PCNL is an effective treatment option for lower pole renal stones that are not responsive to ESWL therapy. The immediate stone-free rate was high, with minimum non-serious complications.