MIP Versus PCNL for Kidney Stone Disease

NCT04767919 | Completed

• 1 other identifier: 191269
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 6

Brief Summary

The decision to use standard percutaneous nephrolithotomy (PCNL) versus mini-percutaneous nephrolithotomy (MIP) has been a subject of much debate in the urological community. The investigators propose a randomized controlled trial to compare the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones. The results of this study will help guide the decision making regarding these two procedures in the US population and provide further insight into the utility and safety of these procedures. A cost analysis will be performed, and it is hypothesized that the reusable components of the Storz MIP set will result in lower costs of the mini-PCNL procedure compared to standard PCNL.

Conditions

Kidney Stone

Keywords

Nephrolithotomy Laser Percutaneous Kidney Stone

Outcome Measures

Primary Outcomes (1)

• Blood Loss

  Blood loss during study operative procedure, up to 4 hours on average, as estimated by hemoglobin levels measured immediately after surgery.

  Intraoperative period, up to 4 hours on average.

Secondary Outcomes (17)

• Intraoperative Complication Rates

  Intraoperative period, up to 4 hours on average.

• Renal Pressure

  Intraoperative period, up to 4 hours on average.

• Operation Time

  Intraoperative period, up to 4 hours on average.

• Anesthesia Time

  Intraoperative period, up to 4 hours on average.

• Hospital Stay Time

  Postoperative period, 24 hours on average.

Study Arms (2)

Standard Percutaneous Nephrolithotomy (sPCNL)

ACTIVE COMPARATOR

The first arm will consist of a Standard of Care standard percutaneous nephrolithotomy (sPCNL)- performed using a 30 Fr access sheath following balloon dilation.

Procedure: Standard Percutaneous Nephrolithotomy (sPCNL)

Minimally Invasive Percutaneous Nephrolithotomy (MIP)

ACTIVE COMPARATOR

The second arm will consist of a Standard of Care mini percutaneous nephrolithotomy (mPCNL)- performed using an 18 Fr access sheath following either balloon dilation or dilation using a single step metal dilator.

Procedure: Minimally Invasive Percutaneous Nephrolithotomy (MIP)

Interventions

Standard Percutaneous Nephrolithotomy (sPCNL) PROCEDURE

Endoscopic stone procedure using a laser placed in the kidney through an 30 Fr access sheath following balloon dilation.

Standard Percutaneous Nephrolithotomy (sPCNL)

Minimally Invasive Percutaneous Nephrolithotomy (MIP) PROCEDURE

Endoscopic stone procedure using a laser placed in the kidney through an 18 Fr access sheath following either balloon dilation or dilation using a single step metal dilator.

Minimally Invasive Percutaneous Nephrolithotomy (MIP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with planned PCNL and a preoperative CT scan
• Urologist obtained access and prone positioning during surgery
• Tract dilation performed either using balloon dilator or a single step mini-PCNL dilation
• Age: ≥18 years' old
• Stone size: 10-25mm
• Gender: Male and female patients
• Patients of all ethnic backgrounds
• Capable of giving informed consent
• Capable and willing to fulfill the requirements of the study
• Pre-existing indwelling nephrostomy tube or ureteral stent permitted

You may not qualify if:

• Anticoagulated or history of coagulopathy (with the exception of daily 81 mg aspirin)
• Conversion to open procedure
• Multiple access tracts
• Inability to give informed consent or unable to meet requirements of the study for any reason

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (6)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

University of California, San Diego, Medical Center

San Diego, California, 92103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State Unversity

Columbus, Ohio, 43210, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University Of British Columbia

Vancouver, British Columbia, V6T, Canada

Location

Related Publications (25)

• Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.

  PMID: 27238616 BACKGROUND

• Desai MR, Sharma R, Mishra S, Sabnis RB, Stief C, Bader M. Single-step percutaneous nephrolithotomy (microperc): the initial clinical report. J Urol. 2011 Jul;186(1):140-5. doi: 10.1016/j.juro.2011.03.029. Epub 2011 May 14.

  PMID: 21575966 BACKGROUND

• Zeng G, Wan S, Zhao Z, Zhu J, Tuerxun A, Song C, Zhong L, Liu M, Xu K, Li H, Jiang Z, Khadgi S, Pal SK, Liu J, Zhang G, Liu Y, Wu W, Chen W, Sarica K. Super-mini percutaneous nephrolithotomy (SMP): a new concept in technique and instrumentation. BJU Int. 2016 Apr;117(4):655-61. doi: 10.1111/bju.13242. Epub 2015 Aug 22.

  PMID: 26220396 BACKGROUND

• Desai J, Solanki R. Ultra-mini percutaneous nephrolithotomy (UMP): one more armamentarium. BJU Int. 2013 Nov;112(7):1046-9. doi: 10.1111/bju.12193. Epub 2013 Jul 11.

  PMID: 23841665 BACKGROUND

• Jackman SV, Docimo SG, Cadeddu JA, Bishoff JT, Kavoussi LR, Jarrett TW. The "mini-perc" technique: a less invasive alternative to percutaneous nephrolithotomy. World J Urol. 1998;16(6):371-4. doi: 10.1007/s003450050083.

  PMID: 9870281 BACKGROUND

• Giusti G, Piccinelli A, Taverna G, Benetti A, Pasini L, Corinti M, Teppa A, Zandegiacomo de Zorzi S, Graziotti P. Miniperc? No, thank you! Eur Urol. 2007 Mar;51(3):810-4; discussion 815. doi: 10.1016/j.eururo.2006.07.047. Epub 2006 Aug 11.

  PMID: 16938385 BACKGROUND

• Xu S, Shi H, Zhu J, Wang Y, Cao Y, Li K, Wang Y, Sun Z, Xia S. A prospective comparative study of haemodynamic, electrolyte, and metabolic changes during percutaneous nephrolithotomy and minimally invasive percutaneous nephrolithotomy. World J Urol. 2014 Oct;32(5):1275-80. doi: 10.1007/s00345-013-1204-2. Epub 2013 Nov 1.

  PMID: 24177788 BACKGROUND

• Guler A, Erbin A, Ucpinar B, Savun M, Sarilar O, Akbulut MF. Comparison of miniaturized percutaneous nephrolithotomy and standard percutaneous nephrolithotomy for the treatment of large kidney stones: a randomized prospective study. Urolithiasis. 2019 Jun;47(3):289-295. doi: 10.1007/s00240-018-1061-y. Epub 2018 Jun 1.

  PMID: 29858913 BACKGROUND

• Sakr A, Salem E, Kamel M, Desoky E, Ragab A, Omran M, Fawzi A, Shahin A. Minimally invasive percutaneous nephrolithotomy vs standard PCNL for management of renal stones in the flank-free modified supine position: single-center experience. Urolithiasis. 2017 Dec;45(6):585-589. doi: 10.1007/s00240-017-0966-1. Epub 2017 Feb 22.

  PMID: 28229197 BACKGROUND

• Cheng F, Yu W, Zhang X, Yang S, Xia Y, Ruan Y. Minimally invasive tract in percutaneous nephrolithotomy for renal stones. J Endourol. 2010 Oct;24(10):1579-82. doi: 10.1089/end.2009.0581.

  PMID: 20839954 BACKGROUND

• Zhong W, Zeng G, Wu W, Chen W, Wu K. Minimally invasive percutaneous nephrolithotomy with multiple mini tracts in a single session in treating staghorn calculi. Urol Res. 2011 Apr;39(2):117-22. doi: 10.1007/s00240-010-0308-z. Epub 2010 Sep 7.

  PMID: 20821200 BACKGROUND

• Mishra S, Kurien A, Ganpule A, Muthu V, Sabnis R, Desai M. Percutaneous renal access training: content validation comparison between a live porcine and a virtual reality (VR) simulation model. BJU Int. 2010 Dec;106(11):1753-6. doi: 10.1111/j.1464-410X.2010.09753.x. Epub 2010 Oct 15.

  PMID: 20950308 BACKGROUND

• Wu C, Hua LX, Zhang JZ, Zhou XR, Zhong W, Ni HD. Comparison of renal pelvic pressure and postoperative fever incidence between standard- and mini-tract percutaneous nephrolithotomy. Kaohsiung J Med Sci. 2017 Jan;33(1):36-43. doi: 10.1016/j.kjms.2016.10.012. Epub 2016 Dec 22.

  PMID: 28088272 BACKGROUND

• Karami H, Gholamrezaie HR. Totally tubeless percutaneous nephrolithotomy in selected patients. J Endourol. 2004 Jun;18(5):475-6. doi: 10.1089/0892779041271580.

  PMID: 15253824 BACKGROUND

• Alsyouf M, Abourbih S, West B, Hodgson H, Baldwin DD. Elevated Renal Pelvic Pressures during Percutaneous Nephrolithotomy Risk Higher Postoperative Pain and Longer Hospital Stay. J Urol. 2018 Jan;199(1):193-199. doi: 10.1016/j.juro.2017.08.039. Epub 2017 Aug 12.

  PMID: 28807646 BACKGROUND

• Kukreja RA, Desai MR, Sabnis RB, Patel SH. Fluid absorption during percutaneous nephrolithotomy: does it matter? J Endourol. 2002 May;16(4):221-4. doi: 10.1089/089277902753752160.

  PMID: 12042103 BACKGROUND

• Loftus CJ, Hinck B, Makovey I, Sivalingam S, Monga M. Mini Versus Standard Percutaneous Nephrolithotomy: The Impact of Sheath Size on Intrarenal Pelvic Pressure and Infectious Complications in a Porcine Model. J Endourol. 2018 Apr;32(4):350-353. doi: 10.1089/end.2017.0602.

  PMID: 29385812 BACKGROUND

• Zhong W, Zeng G, Wu K, Li X, Chen W, Yang H. Does a smaller tract in percutaneous nephrolithotomy contribute to high renal pelvic pressure and postoperative fever? J Endourol. 2008 Sep;22(9):2147-51. doi: 10.1089/end.2008.0001.

  PMID: 18811571 BACKGROUND

• Rettig TC, Verwijmeren L, Dijkstra IM, Boerma D, van de Garde EM, Noordzij PG. Postoperative Interleukin-6 Level and Early Detection of Complications After Elective Major Abdominal Surgery. Ann Surg. 2016 Jun;263(6):1207-12. doi: 10.1097/SLA.0000000000001342.

  PMID: 26135695 BACKGROUND

• Omar M, Noble M, Sivalingam S, El Mahdy A, Gamal A, Farag M, Monga M. Systemic Inflammatory Response Syndrome after Percutaneous Nephrolithotomy: A Randomized Single-Blind Clinical Trial Evaluating the Impact of Irrigation Pressure. J Urol. 2016 Jul;196(1):109-14. doi: 10.1016/j.juro.2016.01.104. Epub 2016 Feb 8.

  PMID: 26869311 BACKGROUND

• Tefekli A, Ali Karadag M, Tepeler K, Sari E, Berberoglu Y, Baykal M, Sarilar O, Muslumanoglu AY. Classification of percutaneous nephrolithotomy complications using the modified clavien grading system: looking for a standard. Eur Urol. 2008 Jan;53(1):184-90. doi: 10.1016/j.eururo.2007.06.049. Epub 2007 Jul 24.

  PMID: 17651892 BACKGROUND

• Okhunov Z, Friedlander JI, George AK, Duty BD, Moreira DM, Srinivasan AK, Hillelsohn J, Smith AD, Okeke Z. S.T.O.N.E. nephrolithometry: novel surgical classification system for kidney calculi. Urology. 2013 Jun;81(6):1154-9. doi: 10.1016/j.urology.2012.10.083. Epub 2013 Mar 26.

  PMID: 23540858 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Michel MS, Trojan L, Rassweiler JJ. Complications in percutaneous nephrolithotomy. Eur Urol. 2007 Apr;51(4):899-906; discussion 906. doi: 10.1016/j.eururo.2006.10.020. Epub 2006 Oct 25.

  PMID: 17095141 BACKGROUND

• Bucuras V, Gopalakrishnam G, Wolf JS Jr, Sun Y, Bianchi G, Erdogru T, de la Rosette J; CROES PCNL Study Group. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: nephrolithotomy in 189 patients with solitary kidneys. J Endourol. 2012 Apr;26(4):336-41. doi: 10.1089/end.2011.0169. Epub 2011 Oct 17.

  PMID: 22004844 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Manoj Monga, M.D.

  UCSD Medical Center, San Diego

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to the Standard of Care treatment they receive for their kidney stone disease
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects will be assigned to one of two Standard of Care treatments for kidney stone disease and complete their treatment using one treatment modality.

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: February 23, 2021
• Study Start: January 1, 2021
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); CA (1)