The benefits of PCNL combined with ureterorenoscopy compared to isolated PCNL in urolithiasis (PRECISE): a multicentre randomised controlled trial protocol.

Abstract

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. 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. 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. 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. The PRECISE study: an investigation into combined kidney stone surgery, Dutch Trial Registry, NL-009577.