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

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.

Conditions

• Kidney Calculi

Interventions

PROCEDURE

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.

PROCEDURE

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).

Sponsors & Collaborators

• Zunyi Medical College

  collaborator OTHER

• Guizhou Provincial People's Hospital

  collaborator OTHER

• Shufu People's Hospital, Kashgar Prefecture, Xinjiang Uygur Autonomous Region

  collaborator UNKNOWN

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Chinese University of Hong Kong

  collaborator OTHER

• Foshan Hospital of Traditional Chinese Medicine

  collaborator OTHER

• ZhuHai Hospital

  collaborator OTHER

• Shenzhen University General Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Hunan Provincial People's Hospital

  collaborator OTHER

• Chinese Academy of Sciences

  collaborator OTHER_GOV

• Affliliated Hospital of Zunyi Medical University

  collaborator UNKNOWN

• The First People's Hospital of Fuquan City

  collaborator UNKNOWN

• Qiannan Buyi and Miao Autonomous Prefecture Hospital

  collaborator UNKNOWN

• Second Affiliated Hospital of Soochow University

  collaborator OTHER

• University of Milan - Fondazione Ca'Granda IRCCS Ospedale Maggiore Policlinico Milano Italy

  collaborator UNKNOWN

• Sabah Al-Ahmad Urology Centre, Kuwait City, Kuwait

  collaborator UNKNOWN

• Military Medical Academy, Sofia, Bulgaria

  collaborator UNKNOWN

• Örebro University Hospital, Örebro, Sweden

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• University College London Hospitals

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• European Association of Urology Section of Endourology (ESEUT), Arnhem, The Netherlands

  collaborator UNKNOWN

• Central Hospital of Xiangtan

  collaborator UNKNOWN

• Cleveland Clinic, Ohio, USA

  collaborator UNKNOWN

• 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

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2025-09-30

Completion

2025-12-31

Countries

• China

Study Locations