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MIP Versus PCNL for Kidney Stone Disease

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ClinicalTrials.gov Identifier: NCT04767919
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Seth Bechis, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Kidney Stone Procedure: Standard Percutaneous Nephrolithotomy (sPCNL) Procedure: Minimally Invasive Percutaneous Nephrolithotomy (MIP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be assigned to one of two Standard of Care treatments for kidney stone disease and complete their treatment using one treatment modality.
Masking: Single (Participant)
Masking Description: Subjects will be blinded to the Standard of Care treatment they receive for their kidney stone disease
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Compare the Operative Outcomes and Complications of Mini-percutaneous Nephrolithotomy (Mini-PCNL) Versus Standard PCNL
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : January 14, 2023
Estimated Study Completion Date : January 14, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Active Comparator: Standard Percutaneous Nephrolithotomy (sPCNL)
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)
Endoscopic stone procedure using a laser placed in the kidney through an 30 Fr access sheath following balloon dilation.

Active Comparator: Minimally Invasive Percutaneous Nephrolithotomy (MIP)
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)
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.




Primary Outcome Measures :
  1. Blood Loss [ Time Frame: Intraoperative period, up to 4 hours on average. ]
    Blood loss during study operative procedure, up to 4 hours on average, as estimated by hemoglobin levels measured immediately after surgery.


Secondary Outcome Measures :
  1. Intraoperative Complication Rates [ Time Frame: Intraoperative period, up to 4 hours on average. ]
    Complication rates occurring during the study operative procedure, up to 4 hours on average, including infundibular and pelvic wall tears and sheath slippage out of parenchyma, measured for all study subjects through study completion, an average of 1 year.

  2. Renal Pressure [ Time Frame: Intraoperative period, up to 4 hours on average. ]
    Operative renal pelvis pressure, measured in mm Hg, measured by a catheter placed transurethral in the ureteropelvic junction during study operative procedure, up to 4 hours on average, measured for every study subject through study completion, up to 1 year on average.

  3. Operation Time [ Time Frame: Intraoperative period, up to 4 hours on average. ]
    Length of time of study operative procedure, up to 4 hours on average, measured in hours, measured for every study subject through study completion, up to 1 year on average.

  4. Anesthesia Time [ Time Frame: Intraoperative period, up to 4 hours on average. ]
    Length of time of administration of anesthesia measured in hours during study operative procedure, up to 4 hours on average, measured for every study subject through study completion, up to 1 year on average.

  5. Hospital Stay Time [ Time Frame: Postoperative period, 24 hours on average. ]
    Length of time of stay in hospital measured in hours, beginning from time study subject leaves operating room after completion of study procedure to the time study subject is discharged from the hospital for study procedure, 24 hours on average, measured for every study subject through study completion, an average of 1 year.

  6. Pain Medication Dose [ Time Frame: Postoperative period, 24 hours on average. ]
    Dose of pain medication administered to study subject beginning from the time study subject leaves the operating room after completion of study procedure, to the time study subject is discharged from the hospital for study procedure, 24 hours on average, measured for every study subject through study completion, an average of 1 year.

  7. Urine Output [ Time Frame: Postoperative period, 24 hours on average. ]
    Volume of urine produced by study subject, measured in milliliters, beginning from time study subject leaves operating room after completion of study procedure to discharge from the hospital for study procedure, 24 hours on average, measured for every study subject through study completion, an average of 1 year.

  8. ED Visits [ Time Frame: Postoperative period, up to 6 weeks. ]
    Frequency of visits to emergency room, beginning from time study subject leaves operating room after completion of study procedure to the time study subject exits the study, up to 6 weeks, measured for every study subject through study completion, an average of 1 year.

  9. Readmission [ Time Frame: Postoperative period, up to 6 weeks. ]
    Frequency of readmission to hospital, beginning from time study subject leaves operating room after completion of study procedure to the time study subject exits the study, up to 6 weeks, measured for every study subject through study completion, an average of 1 year.

  10. Reoperation [ Time Frame: Postoperative period, up to 6 weeks. ]
    Frequency of reoperation on same side kidney as original study procedure, beginning from time study subject leaves operating room after completion of study procedure to the time study subject exits the study, up to 6 weeks, measured for every study subject through study completion, an average of 1 year.

  11. Imaging [ Time Frame: Postoperative period, up to 6 weeks ]
    Presence of stone fragments as viewed on imaging of kidney by CT scan, KUB, or ultrasound, beginning from time study subject leaves operating room after completion of study procedure to the time study subject exits the study, up to 6 weeks, measured for every study subject through study completion, an average of 1 year.

  12. Quality of Life Questionnnaire [ Time Frame: Postoperative period, up to 6 weeks. ]
    Results of Wisconsin Quality of Life Survey, measured from 1 to 5 with 1 being very true and always and 5 being not at all true and never, administered beginning from time study subject leaves operating room after completion of study procedure to the time study subject exits the study, up to 6 weeks, measured for every study subject through study completion, an average of 1 year.

  13. IL-6 Results [ Time Frame: Postoperative period, up to 8 hours on average. ]
    Measurement of Interlukin-6 in picograms per milliliters immediately after completion of study operative procedure, 0-8 hours on average, measured for every study subject through study completion, an average of 1 year.

  14. PCT Results [ Time Frame: Postoperative period, up to 8 hours on average. ]
    Measurement of procalcitonin in nanograms per milliliters immediately after completion of study procedure, 0-8 hours on average, measured for every study subject through study completion, an average of 1 year.

  15. Pain Intensity [ Time Frame: Postoperative period, up to 6 weeks. ]
    Pain measured using Stanford Pain Scale, a 0-10 scale with 10 being the greatest pain, beginning from time study subject leaves operating room after completion of study operative procedure to the time study subject exits the study, up to 6 weeks, measured for every study subject through study completion, an average of 1 year.

  16. Postoperative Complication Rates [ Time Frame: Postoperative period, up to 6 weeks. ]

    Complications rates beginning from time study subject leaves operating room after completion of study procedures to exit from study, up to 6 weeks, including fever, SIRS, blood transfusion, pleural effusions, urine leak, urinary retention, perirenal hematoma or urinoma, post-operative stent placement, ICU admission, and Clavien-Dindo Classification, measured for every study subject through study completion, an average of 1 year.

    ed study procedures


  17. Pain Medication Frequency [ Time Frame: [Time Frame: Postoperative period, 24 hours on average.] ]
    Frequency of pain medication administered to study subject beginning from the time study subject leaves the operating room after completion of study procedure, to the time study subject is discharged from the hospital for study procedure, 24 hours on average, measured for every study subject through study completion, an average of 1 year.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04767919


Contacts
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Contact: Seth Bechis, M.D. 619-543-2869 sbechis@ucsd.edu
Contact: Paul F Zupkas, Ph.D. 619-890-5197 pzupkas@ucsd.edu

Locations
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United States, California
University of California, San Diego, Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Seth Bechis, M.D.    619-543-2869    sbechis@ucsd.edu   
Contact: Paul F Zupkas, Ph.D.    619-890-5197    pzupkas@ucsd.edu   
Sub-Investigator: Manoj Monga, M.D.         
Sub-Investigator: Roger Sur, M.D.         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Study Chair: Manoj Monga, M.D. UCSD Medical Center, San Diego
Publications:

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Responsible Party: Seth Bechis, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04767919    
Other Study ID Numbers: 191269
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seth Bechis, University of California, San Diego:
Nephrolithotomy Laser Percutaneous Kidney Stone
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi