Clinical trial NCT03771365: Standard-PCNL vs Mini-PCNL vs Super-mini PCNL for the Treatment of ≥2 cm Renal Stone
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stone, Kidney
Lithiasis Renal
Surgery
Keywords: percutaneous nephrostolithotomy
renal stone
safety
efficacy
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Military Medical Academy, Bulgaria
name: Massachusetts General Hospital
name: Hospital de Clinicas José de San Martín
name: Goldstadt Private Clinic
name: University College London Hospitals
name: Hospital de Base do Distrito Federal
name: Mexican National Council of Urology
name: Vancouver General Hospital
name: Lions Kidney Hospital and Urology Institute
name: Mt. Carmel Diocesan General Hospital
name: Clinical Emergency County Hospital
name: University of Belgrade
name: Hospital das Clínicas, University of Sao Paulo Medical School
name: Vayodha and Venus International Hospitals
name: University Hospital of Vinalopo
name: Sismanoglio General Hospital
name: New Mowasat Hospital
First posted: 2018-12-11
Enrollment: 3000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

1. Bleeding complication: hematocrit drop (g/L) and rate of transfusion (%).
2. Infectious complication: rate of getting fever (≥38℃) (%) and urosepsis (%).
3. Intraoperative indexes: operating time (mins), rate of tubeless/total tubeless (%).
4. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Stone free rate (SFR) (%)
timeFrame: 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:
measure: Perioperative complications
timeFrame: intraoperatively or ≤ 1 month postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Guohua Zeng, PH.D & MD
role: PRINCIPAL_INVESTIGATOR
References: