Standard-PCNL vs Mini-PCNL vs Super-mini PCNL for the Treatment of ≥2 cm Renal Stone
An International Multi-center Prospective Cohort Study Comparing the Safety and Efficacy of Super-mini-PCNL, Mini-PCNL and Standard PCNL in the Treatment of ≥2cm Renal Stones
1 other identifier
observational
3,000
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2018
CompletedFirst Posted
Study publicly available on registry
December 11, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedDecember 11, 2018
December 1, 2018
2 years
November 10, 2018
December 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stone free rate (SFR) (%)
Stone free rate (SFR) (%) are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were defined as ≦ 4mm, asymptomatic, non-obstructive and non-infectious stone particles.
1-3 months after the day of DJ stent/ureteral catheter removal or the day of operation (if no DJ stent or ureteral catheter placed postoperatively).
Secondary Outcomes (1)
Perioperative complications
intraoperatively or ≤ 1 month postoperatively
Study Arms (3)
Standard-PCNL
Perform PCNL with ≥24 Fr access tract for the treatment of ≥2 renal stones
Mini-PCNL
Perform PCNL with 12-20 Fr access tract for the treatment of ≥2 renal stones
Super-mini PCNL
Perform SMP for the treatment of ≥2 renal stones
Interventions
percutaneous nephrostolithotomy (PCNL) with ≥24 Fr access tract for the treatment of ≥2 cm renal stone
percutaneous nephrostolithotomy (PCNL) with 12-20 Fr access tract for the treatment of ≥2 cm renal stone
percutaneous nephrostolithotomy (PCNL) with 10-14 Fr access tract for the treatment of ≥2 cm renal stone
Eligibility Criteria
All patients ≥14 years with ≥2 cm renal stone who are planned for Standard-PCNL, Mini-PCNL or SMP are eligible for this study.
You may qualify if:
- Patient ≥14 years old
- Patient is a candidate for Standard-PCNL, Mini-PCNL or SMP treatment of a renal stone
You may not qualify if:
- Patient \<14 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital of Guangzhou Medical Universitylead
- Military Medical Academy, Bulgariacollaborator
- Massachusetts General Hospitalcollaborator
- Hospital de Clinicas José de San Martíncollaborator
- Goldstadt Private Cliniccollaborator
- University College London Hospitalscollaborator
- Hospital de Base do Distrito Federalcollaborator
- Mexican National Council of Urologycollaborator
- Vancouver General Hospitalcollaborator
- Lions Kidney Hospital and Urology Institutecollaborator
- Mt. Carmel Diocesan General Hospitalcollaborator
- Clinical Emergency County Hospitalcollaborator
- University of Belgradecollaborator
- Hospital das Clínicas, University of Sao Paulo Medical Schoolcollaborator
- Vayodha and Venus International Hospitalscollaborator
- University Hospital of Vinalopocollaborator
- Sismanoglio General Hospitalcollaborator
- New Mowasat Hospitalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guohua Zeng, PH.D & MD
The First Affiliated Hospital of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president
Study Record Dates
First Submitted
November 10, 2018
First Posted
December 11, 2018
Study Start
January 1, 2019
Primary Completion
January 1, 2021
Study Completion
January 1, 2022
Last Updated
December 11, 2018
Record last verified: 2018-12