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

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, 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.

Conditions

• Kidney Calculi

Interventions

PROCEDURE

suction mini percutaneous nephrolithotomy

18Fr suction sheath (Weili, China) was inserted, and 12Fr mini-nephroscope was used, kidney stones was fragmented by pneumatic lithotriptor (LithoClast Master, Switzerland) or Ho:YAG laser（0.8-1.0W\*20-30Hz）, and stone fragments was sucked out with the suction sheath.

PROCEDURE

standard percutaneous nephrolithotomy

24-30Fr sheath was inserted, and 20Fr nephroscope (Richard Wolf, Germany) was used, kidney stones was disintegrated and sucked out by ultrasonic-lithotripter (LithoClast Master, EMS, Switzerland or ShockPluse-SE, Olympus).

Sponsors & Collaborators

• Aceves of Wake Forest University Medical Center

  collaborator UNKNOWN

• University College London Hospital

  collaborator UNKNOWN

• San Paolo Hospital, University of Milan

  collaborator UNKNOWN

• Örebro University, Sweden

  collaborator OTHER

• San Bassiano Hospital, Vicenza, Italy

  collaborator UNKNOWN

• ALAMIRI Hospital, SABAH ALAHMAD Urology Center, Kuwait

  collaborator UNKNOWN

• Biruni University Medical School, İstanbul, Turkey

  collaborator UNKNOWN

• Jose R. Reyes Memorial Medical Center, Manila, Philippines.

  collaborator UNKNOWN

• Military Medical Academy, Bulgaria

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Zunyi Medical College

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Wuhan University

  collaborator OTHER

• The Jiangxi Provincial People's Hospital

  collaborator UNKNOWN

• Affiliated Hospital of Guangdong Medical University

  collaborator OTHER

• ZhuHai Hospital

  collaborator OTHER

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Xiangtan Central Hospital

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  lead OTHER

Principal Investigators

• Guohua Zeng, Ph.D & MD · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2023-04-01

Completion

2023-12-01

Countries

• China

Study Locations