MIP Versus PCNL for Kidney Stone Disease

Completed · Not applicable

Conditions studied: Kidney Stone

In brief

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.

Key facts

Study ID

NCT04767919

Run by

University of California, San Diego

People needed

75

Starts

2021-01-01

Expected to finish

2024-06-07

Last updated by the study team

2025-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• University of California, San Diego, Medical Center — San Diego, California, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State Unversity — Columbus, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University Of British Columbia — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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