Mini-PCNL Versus Standard-PCNL For The Management of 20-40 mm Size Kidney Stones

Summary

Percutaneous nephrolithotomy (PCNL) has been considered as the first-line choice for the management of \>20mm kidney stones. The traditional nephrostomy tract of PNL was dilated to 24-30F, which is referred to as "Standard-PCNL". Standard PNL has an ideal stones free rate (SFR), however, at the cost of severe morbidity. To decrease the disadvantages related to standard PNL, "mini-perc" or "mini-PCNL", 20F or less, was first introduced to pediatric procedure in 1997, and subsequently implemented in adults with the expectation of similar SFR and low morbidity in the past twenty years. Although abundant efforts have been done, whether mini-perc outweigh standard-PNL for the treatment of \>20mm calculis in terms of efficiency and safety remains controversial.

To solve this problem, we performed this multicenter, parallel, open-label randomized controlled trial (RCT).

Conditions

• Kidney Calculi

Interventions

PROCEDURE

Mini Percutaneous Nephrolithotomy

patients undergo PNCL with 18Fr nephrostomy tract

PROCEDURE

Percutaneous Nephrolithotomy

patients undergo PNCL with 24Fr nephrostomy tract

Sponsors & Collaborators

• Baoshan No.2 People's Hospital

  collaborator UNKNOWN

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• People's Hospital of Nanhai District, Foshan

  collaborator UNKNOWN

• Yichang Yiling Hospital

  collaborator UNKNOWN

• Suzhou Municipal Hospital

  collaborator OTHER

• First Affiliated Hospital of Gannan Medical University

  collaborator OTHER

• General Hospital of Shenyang Military Region

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• The Second Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Beijing Chuiyangliu Hospital

  collaborator OTHER_GOV

• Fujian Medical University Union Hospital

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• 181st hospital of Chinese People's Liberation Army

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Jiangmen Central Hospital

  collaborator OTHER

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• The Sixth Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Jining First People's Hospital

  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

2016-01-01

Primary Completion

2019-08-01

Completion

2019-08-20

Countries

• China

Study Locations