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NCT05088213

Suction Mini-PCNL Versus Standard PCNL for the Management of 2-4cm Kidney Stones

Status unknown NA Last updated 21 October 2021
What this trial tests

NA trial testing suction mini percutaneous nephrolithotomy in Kidney Calculi in 960 participants. Status unknown.

Timeline
1 December 2021
Primary endpoint
1 April 2023
1 December 2023

Quick facts

Lead sponsorThe First Affiliated Hospital of Guangzhou Medical University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment960
Start date1 December 2021
Primary completion1 April 2023
Estimated completion1 December 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Who can join

Adults 18 to 70, any sex, with Kidney Calculi. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Percutaneous nephrolithotomy (PCNL) was the first line choice for the management of renal calculi larger than 20 mm. A relative large tract of 24-30Fr was widely used in standard PCNL (sPCNL), which was believed to bring tract-related bleeding. In order to reduce the risk of tract-related bleeding, Chinese urologists used 18Fr mini-tract in the PCNL procedures, which was well known as minimally invasive percutaneous nephrolithotomy (mini-PCNL). In an international multi-centre randomized controlled trail (RCT) , mini-PCNL and sPCNL was compared in the management of 2-4cm kidney stones, the stone free rate (SFR) in mini-PCNL was equal to that of sPCNL. However, since the tract was smaller, the postoperative pain in mini-PCNL was less, the postoperative recovery was faster, and the hospital stay was shorter. Recently, professor Guohua Zeng developed enhanced super-mini-PCNL (eSMP) technique. When compared to traditional mini-PCNL, suction mini-PCNL using 18Fr suction sheath increased the stone removal efficiency and reduced the renal pelvic pressure. While in the present regard, whether suction mini-PCNL play an more efficent and safe role in the management of 2-4cm kidney stones was worthy of further study. So, the investigators would like to have an international multi-centre RCT to certify our hypothesis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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.
    Zhong W, Jiang K, Zhang X, Leung CH, et al · · 2026 · PMID 41746369 · DOI 10.1007/s00345-026-06302-7

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Other recruiting trials for Kidney Calculi

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