Safety and Effectiveness of Antegrade Flexible Ureteroscopy-Assisted Percutaneous Nephrolithotomy… (NCT07172373) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Effectiveness of Antegrade Flexible Ureteroscopy-Assisted Percutaneous Nephrolithotomy for Staghorn Calculi
420 participantsStarted 2025-10-01
Plain-language summary
Objective This study aims to evaluate the safety and efficacy of antegrade flexible ureteroscopy-assisted PCNL for the treatment of staghorn calculi, compared with standard PCNL.
Methods This prospective, multicenter, randomized controlled trial plans to enroll 420 patients with staghorn calculi, randomly assigned into two groups: the experimental group (antegrade flexible ureteroscopy-assisted PCNL, n=210) and the control group (standard PCNL, n=210). The primary endpoint is stone-free rate (defined as no residual fragment ≥2 mm on postoperative CT). Secondary endpoints include operative time, number of percutaneous tracts, rate of secondary procedures, hemoglobin decrease, postoperative complications (Clavien-Dindo classification), and length of hospital stay. All patients will undergo CT evaluation on postoperative day 2. Subgroup analysis will be performed according to the number of stone branches (≥5 vs \<5).
Who can participate
Age range
18 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:
Staghorn calculi confirmed by non-contrast CT of the urinary system; Age ≥18 years; General condition suitable for surgical treatment; Ability to understand and voluntarily sign the informed consent form.
Exclusion Criteria:
Solitary kidney or congenital anomalies (such as horseshoe kidney or ectopic kidney); Patients with severe preoperative pyelonephritis; Patients with psychiatric disorders or unwilling to cooperate; Patients with uncontrolled diabetes or hypertension who cannot tolerate surgery; Patients with coagulation disorders; Patients deemed unsuitable for participation in this trial by the investigator.
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
Immediately stone-free rate (SFR)
Timeframe: On postoperative day 2, a non-contrast CT of the urinary system will be performed, and the absence of residual fragments larger than 2 mm will be defined as stone-free.