Standard-PCNL vs Mini-PCNL vs Super-mini PCNL for the Treatment of ≥2 cm Renal Stone

NCT03771365 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2018-12-11

No results posted yet for this study

Summary

Background: Standard-PCNL was considered as the first choice for ≥2 cm renal stones. Miniaturized technique Mini-PCNL has also been implicated in the past two decades. Recently, Super-mini PCNL (SMP) was introduced to treated ≤2.5cm renal stone. The miniaturized techniques seemed to take a longer operating time and have risk of getting infectious complications. However, there is no high quality of evidence showing that which kind of PCNL is best or what kind of patients is suitable for standard-PCNL, mini-PCNL or SMP.

Objective: To compare the efficacy and safety of Standard-PCNL (≥24Fr), Mini-PCNL (12-20Fr) and SMP(10-14Fr) for the treatment of ≥2 cm renal stones Study design: This study is a prospective, observational, international, multicenter registry cohort study Study population: All patients ≥14 years with ≥2 cm renal stone who are planned for Standard-PCNL, Mini-PCNL or SMP are eligible for this study.

Conditions

  • Stone, Kidney
  • Lithiasis Renal
  • Surgery

Interventions

PROCEDURE

Standard-PCNL

percutaneous nephrostolithotomy (PCNL) with ≥24 Fr access tract for the treatment of ≥2 cm renal stone

PROCEDURE

Mini-PCNL

percutaneous nephrostolithotomy (PCNL) with 12-20 Fr access tract for the treatment of ≥2 cm renal stone

PROCEDURE

SMP

percutaneous nephrostolithotomy (PCNL) with 10-14 Fr access tract for the treatment of ≥2 cm renal stone

Sponsors & Collaborators

  • Military Medical Academy, Bulgaria

    collaborator OTHER
  • Massachusetts General Hospital

    collaborator OTHER
  • Hospital de Clinicas José de San Martín

    collaborator OTHER
  • Goldstadt Private Clinic

    collaborator UNKNOWN
  • University College London Hospitals

    collaborator OTHER
  • Hospital de Base do Distrito Federal

    collaborator UNKNOWN
  • Mexican National Council of Urology

    collaborator UNKNOWN
  • Vancouver General Hospital

    collaborator OTHER
  • Lions Kidney Hospital and Urology Institute

    collaborator UNKNOWN
  • Mt. Carmel Diocesan General Hospital

    collaborator UNKNOWN
  • Clinical Emergency County Hospital

    collaborator UNKNOWN
  • University of Belgrade

    collaborator OTHER
  • Hospital das Clínicas, University of Sao Paulo Medical School

    collaborator UNKNOWN
  • Vayodha and Venus International Hospitals

    collaborator UNKNOWN
  • University Hospital of Vinalopo

    collaborator UNKNOWN
  • Sismanoglio General Hospital

    collaborator OTHER
  • New Mowasat Hospital

    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

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-01-01
Completion
2022-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03771365 on ClinicalTrials.gov