Suction mini PCNL vs standard PCNL(2-4cm stones). An international RCT
Research type
Research Study
Full title
Suction mini PCNL versus standard PCNL for the management of 2-4cm kidney stones: An international multi-center randomized controlled trial
IRAS ID
318629
Contact name
Simon Khuat Choong
Contact email
Sponsor organisation
University College London Hospital
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
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, urologists used 18Fr mini-tract in the PCNL procedures, which was well known as minimally invasive percutaneous nephrolithotomy (mini-PCNL). The tract in mini-PCNL was small, thus the stones was required to be designated into smaller fragments before extraction, which would potentially prolong the operation time. Moreover, due to the small tract in mini-PCNL, if the drainage of perfusion was not sufficient, the renal pelvic pressure would increase, thus bring backflow and following infection and fever. There was always controversial in mini-PCNL with regards to the renal pelvic pressure and operation time.
Exactly, in an international multi-center randomized controlled trail (RCT) already published in EU (Mini PCNL is a noninferior modality to standard percutaneous nephrolithotomy for the management of 20-40 mm renal calculi: a multicentre RCT), mini-PCNL and sPCNL were 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. Furthermore, 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 a more efficient and safe role in the management of 2-4cm kidney stones was worthy of further study. So, we would like to have an international multi-center RCT to certify our hypothesis.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
23/YH/0263
Date of REC Opinion
16 Dec 2023
REC opinion
Unfavourable Opinion