- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03771365
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND AND RATIONALE Percutaneous nephrolithotomy (PCNL) is the first-choice for the treatment of renal stone ≥20 mm with high stone free rate (SFR). However, there are some sever complications such as bleeding. Severe bleeding needs arterial embolization, which might impair the renal function. The size of percutaneous access tract has been proven to be closely related to the risk of bleeding complications. Mini-PCNL was firstly introduced by Jackman in 1998 to treat pediatric renal stone with the aim to lower the morbidity. Mini-PCNL was gradually applied to adults. In recent years, urologists were still attempting to reduce size of the sheath and modify the sheath. They aimed to reduce the risk of bleeding. The first generation SMP consists of a 10-14 F access sheath with a suction-evacuation function and a 7-F nephroscope with enhanced irrigation was introduced by Guohua Zeng's group in 2014. In 2016, Guohua Zeng's group continued to introduce a modified SMP technique and system. The most remarkable feature of the new generation super-mini percutaneous nephrolithotomy (New-SMP) was metal irrigation-suction sheath which made the new system have higher efficiency than the old one. With the modified SMP technique and system, SMP was performed to treat large renal stone. (≥2cm). Moreover, SMP with an irrigation-suction sheath obviously improved the efficiency of removing the fragments and lower the intrapelvic pressure.
Although miniaturized techniques decreased the bleeding-related morbidity and have a similar SFR, they seemed to take a longer operating time and have risk of getting infectious complications. However, till now, no high quality of evidence demonstrated that what size of tract is the best for the treatment of ≥2 cm renal stone. Perhaps the investigators should find out a subgroup suitable for standard-PCNL, Mini-PCNL or SMP respectively.
STUDY OBJECTIVES The aim of this registry is to review current clinical practice on PCNL for stone treatment. The investigators will explore the answers to the following questions: What kind of PCNL urologists prefers to used? Is there a best cutoff based on the size of stones to divide the patients into subgroups, or a scoring system to decide which kind of PCNL is the best choice for individuals? Primary Objective To compare the stone free rate (SFR) (%) among standard-PCNL, Mini-PCNL and SMP for the treatment of ≥2 cm renal stone.
Secondary Objectives
- Bleeding complication: hematocrit drop (g/L) and rate of transfusion (%).
- Infectious complication: rate of getting fever (≥38℃) (%) and urosepsis (%).
- Intraoperative indexes: operating time (mins), rate of tubeless/total tubeless (%).
- Postoperative indexes: hospital stay (mins), visual analogue scale (VAS) score (range from 0-10, the higher value represents the worse outcome) STUDY DESIGN This study is a prospective, observational, international, multicenter registry cohort study SELECTION AND ENROLLMENT OF PARTICIPANTS Clinical Recruitment All sites for this pilot study are recruited by IAU Members. Each participating center should obtain ethical approval, as needed, according to local regulations.
Each participating centre will include all consecutive eligible patients. PCNL procedures are performed according local protocols and surgeons' own propensity. Data will be collected in the IAU online platform (http://47.74.212.47/#/login), which is developed by IAU. Each participating center has own account and password to login and collect data. Data analysis will be coordinated by IAU.
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.
Surgical procedure The procedure of SMP, mini-PCNL and Standard-PCNL was according to surgeons' propensity, the related details were recorded online.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chao Cai, PH.D & MD
- Phone Number: +86 13512780911
- Email: 673059209@qq.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient ≥14 years old
- Patient is a candidate for Standard-PCNL, Mini-PCNL or SMP treatment of a renal stone
Exclusion Criteria:
- Patient <14 years old
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Standard-PCNL
Perform PCNL with ≥24 Fr access tract for the treatment of ≥2 renal stones
|
percutaneous nephrostolithotomy (PCNL) with ≥24 Fr access tract for the treatment of ≥2 cm renal stone
|
Mini-PCNL
Perform PCNL with 12-20 Fr access tract for the treatment of ≥2 renal stones
|
percutaneous nephrostolithotomy (PCNL) with 12-20 Fr access tract for the treatment of ≥2 cm renal stone
|
Super-mini PCNL
Perform SMP for the treatment of ≥2 renal stones
|
percutaneous nephrostolithotomy (PCNL) with 10-14 Fr access tract for the treatment of ≥2 cm renal stone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stone free rate (SFR) (%)
Time Frame: 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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perioperative complications
Time Frame: intraoperatively or ≤ 1 month postoperatively
|
Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on
|
intraoperatively or ≤ 1 month postoperatively
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1stAHGZMU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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