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Suction Mini-PCNL Versus Standard PCNL for the Management of 2-4cm Kidney Stones
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Summary
Percutaneous nephrolithotomy (PCNL) is recommended as the first-line treatment choice for kidney stones larger than 2cm in international guidelines . However, tract-related complications affecting renal parenchymal and blood vessels have always been a concern . The mini-PCNL technique which uses a smaller tract (≤18 Fr) has been introduced to decrease tract-related complications . Nevertheless, the smaller mini-PCNL tract necessitates fragmentationi of stones into smaller pieces before extraction, potentially prolonging the operative time. Additionally, higher pressure irrigation is often required to flush out fragments by vacuum cleaner effect. If the drainage of irrigation fluid is insufficient via a smaller tract, the intrarenal pressure (IRP) may build up, leading to pyelovenous backflow and infectious complications. Suction application in mini-PCNL has the potential to enhance stone fragments removal efficiency, maintain low IRP, and decrease potential postoperative infection complications. In the pre-suction era, mini-PCNL achieved noninferior stone-free rates (SFR) and operative times compared to standard PCNL, along with benefits of reduced bleeding, less postoperative pain, and shorter hospital stay. However, high-level evidence regarding whether suction mini-PCNL can attain comparable outcomes to standard PCNL is still lacking. Therefore, we have designed this multicenter, international, randomized controlled noninferiority trial comparing suction mini-PCNL with standard PCNL in the management of 2-4 cm kidney stones.
Official title: Suction Mini-Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy for the Management of 2-4 cm Kidney Stones: Study Protocol for an International, Multicenter, Parallel-group, Noninferiority, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
960
Start Date
2021-12-01
Completion Date
2025-12-31
Last Updated
2026-06-30
Healthy Volunteers
No
Conditions
Interventions
suction mini percutaneous nephrolithotomy
For suction mini-PCNL, 18Fr suction sheath (Wellead, China) will be inserted, and 12Fr mini-nephroscope will be used. Renal stones will be fragmented by pneumatic lithotriptor or Ho:YAG laser (1.0-2.0J ×20-30Hz), and stone fragments will be aspirated out via the suction sheath.
standard percutaneous nephrolithotomy
For standard PCNL, 24Fr sheath will be inserted, and 20Fr nephroscope (Richard Wolf, Germany) will be used. Renal stones will be fragmented and aspirated using an ultrasonic-lithotripter (LithoClast Master, EMS or ShockPluse-SE, Olympus).
Locations (1)
Department of Urology, Minimally invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China