Mini-PCNL Versus Standard-PCNL For The Management of 20-40 mm Size Kidney Stones (NCT02635048) | Clinical Trial Compass
CompletedNot Applicable
Mini-PCNL Versus Standard-PCNL For The Management of 20-40 mm Size Kidney Stones
China1,980 participantsStarted 2016-01-01
Plain-language summary
Percutaneous nephrolithotomy (PCNL) has been considered as the first-line choice for the management of \>20mm kidney stones. The traditional nephrostomy tract of PNL was dilated to 24-30F, which is referred to as "Standard-PCNL". Standard PNL has an ideal stones free rate (SFR), however, at the cost of severe morbidity. To decrease the disadvantages related to standard PNL, "mini-perc" or "mini-PCNL", 20F or less, was first introduced to pediatric procedure in 1997, and subsequently implemented in adults with the expectation of similar SFR and low morbidity in the past twenty years. Although abundant efforts have been done, whether mini-perc outweigh standard-PNL for the treatment of \>20mm calculis in terms of efficiency and safety remains controversial.
To solve this problem, we performed this multicenter, parallel, open-label randomized controlled trial (RCT).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients consent for percutaneous renal stone removal
. Age 18 to 70 years
. Normal renal function
. ASA score Ⅰ and Ⅱ
. Renal stones 20-40mm
Exclusion criteria
. Patients with solitary kidney.
. Uncorrected coagulopathy and active urinary tract infection (UTI)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stone free rate (SFR)
Timeframe: 1 month after removing the pigtail stent
Trial details
NCT IDNCT02635048
SponsorThe First Affiliated Hospital of Guangzhou Medical University