This randomised controlled trial compares outcomes of ECIRS and PCNL in patients with urolithiasis, suggesting improved stone-free rates and reduced complications.
Background Percutaneous nephrolithotomy (PCNL) often fails to achieve complete stone clearance with a single procedure. Residual fragments, irrespective of size, are associated with increased stone‐related morbidity and a higher likelihood of re‐intervention. Endoscopic combined intrarenal surgery (ECIRS), which integrates PCNL with retrograde ureterorenoscopy, may improve stone‐free rates and reduce morbidity. However, given the potential for increased risks and greater resource utilisation, a comprehensive randomised controlled trial is warranted. The ‘PRECISE’ trial is designed to compare ECIRS and PCNL in terms of efficacy, safety, stone‐related morbidity, and resource utilisation. Study Design The PRECISE is a prospective, non‐blinded, randomised, parallel‐group, multicentre interventional trial involving patients eligible for percutaneous kidney stone surgery. Patients will be randomised in a 1:1 ratio to undergo either ECIRS or standard PCNL. Endpoints The primary endpoint is the Grade A (0 mm) stone‐free rate on postoperative computed tomography (CT) at 4 weeks. Secondary radiological endpoints include Grade B (≤2 mm) and Grade C (≤4 mm) stone‐free rates at 4 weeks, stone volume reduction, 1‐year stone‐free rates, and radiation exposure. Additional outcomes include complications, operative duration, stone‐related events (SREs), health‐related quality of life (HRQoL), cost differences, cost‐effectiveness and environmental impact, assessed up to 5 years postoperatively. Patients and Methods Adults (aged ≥18 years) eligible for percutaneous kidney stone surgery, where retrograde access is feasible, will be recruited. The main exclusion criteria comprise papillary calcifications, renal transplant procedures, and (suspected) pregnancy. A total of 350 patients (175 per arm) will be recruited. Follow‐up includes CT imaging with clinical consultations at 4 weeks and 1 year to evaluate radiological outcomes, complications, SREs, and HRQoL. Telephone interviews at 3 and 5 years will assess long‐term SREs and HRQoL. We aim to retrospectively evaluate cost differences, cost‐effectiveness, and environmental impact. Trial Registration The PRECISE study: an investigation into combined kidney stone surgery, Dutch Trial Registry, NL‐009577.
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Suijker et al. (2025) studied this question.
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