IAU Percutaneous Nephrolithotripsy Study (IAUPCNL)
International Alliance of Urolithiasis Percutaneous Nephrolithotripsy Study
During the past 10-15 years, important advancements have been witnessed in percutaneous nephrolithotomy (PCNL) techniques and instrumentation. The development of miniaturized PCNL techniques and modern laser technologies has contributed to lower complication rates, alongside changes in exiting strategies and postoperative drainage protocols. Ultrasound is increasingly utilized to create percutaneous access, and many medical centers have transitioned to the supine position for PCNL or perform Endoscopic Combined Intrarenal Surgery (ECIRS). All these developments have helped to individualize treatment strategies and to improve clinical outcomes for patients. However, there remains an ongoing discussion regarding the optimal indications and limitations of the different miniaturized PCNL techniques compared to standard PCNL and retrograde intrarenal surgery (RIRS).
This prospective observational study is organized under the auspices of the International Alliance of Urolithiasis (IAU) and focuses on the contemporary indications, surgical techniques, instrumentation, exiting strategies, efficacy, and risk factors for intraoperative and postoperative complications of PCNL. Participating investigators will collect data on the PCNL procedures performed in their respective clinical centers prospectively for a period of 12-18 months. The study will be initiated in each clinical center following formal approval from the IAU Scientific Committee, which will also announce the conclusion of the study.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
OBJECTIVES
Primary Study Objective:
To evaluate the contemporary indications, clinical efficacy, and safety profile of percutaneous nephrolithotomy (PCNL) for the treatment of renal stones.
Secondary Study Objectives:
To systematically assess intraoperative and postoperative complications of PCNL utilizing the standardized Clavien-Dindo classification system.
To identify and define specific independent risk factors contributing to intraoperative and postoperative complications following PCNL.
To execute a comparative efficacy analysis between miniaturized PCNL techniques and standard PCNL stratified by stone size and complexity.
The captured variables will undergo comprehensive statistical analysis to determine their respective effects on final procedural outcomes, stone-free rates, and perioperative complications. These parameters are categorized as follows:
Patient Preoperative Variables: Age, comorbidities, Body Mass Index (BMI), active anticoagulant/antiplatelet medications, stone configuration, presence of a solitary functioning kidney, and congenital musculoskeletal or anatomical renal abnormalities.
Preoperative Imaging and Diagnostics: Modalities utilized for surgical planning, stone density (Hounsfield units), cumulative stone size/burden, and stone number/location.
Preoperative Urinary Tract Status: Documented frequency of urinary tract infections (UTIs), identification of isolated bacterial strains, and protocols for preoperative antibiotic treatment (including specific drug types and duration).
Intraoperative Variables and Technical Access: Patient positioning (prone vs. supine variations), imaging modalities utilized for renal access puncture, definitive tract size, and the specific method of tract dilatation (balloon, metal telescopic, sequential fascial, or single-step/one-shot dilators).
Instrumentation and Efficacy Metrics: Type and size of the percutaneous access sheath, specific surgical instrumentation utilized (micro, mini, super-mini, ultra-mini, or standard PCNL), energy modalities used for lithotripsy fragmentation, and methods deployed for stone fragment extraction or evacuation.
Exiting Strategies and Postoperative Care: Choice of post-procedural drainage protocols (totally tubeless, tubeless, or standard nephrostomy tube placement, including tube type and size), time to drainage extraction, and total postoperative length of hospital stay.
Morbidity and Follow-Up: Documentation of procedural morbidity, with all adverse events classified according to the Clavien-Dindo system, alongside the subsequent management and treatment of any recorded complications.
DATA COLLECTION AND PROTOCOL MANAGEMENT Patients will be enrolled prospectively and consecutively across participating international sites, targeting a cumulative registry sample of up to 10,000 participants.
The International Alliance of Urolithiasis (IAU) Scientific Committee oversees and provides formal institutional approval for the initiation of data collection at each participating clinical center. Institutions participating in the registry must submit a formal application and cover letter to the IAU Scientific Committee.
Data collection is conducted via a secure, web-based data management system, with each approved clinical center utilizing a unique, personal username and password for system access. Every participating clinical site designates a local study coordinator responsible for ensuring accurate data entry and compliance.
To maintain data integrity, completeness, and quality control across all international centers, the IAU Scientific Committee has established a dedicated Audit Committee for continuous monitoring. Final data analysis and scientific reporting will be guided and coordinated directly by the IAU Scientific Committee.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Sofia-Grad
-
Sofia, Sofia-Grad, Bulharsko, 1606
- Foundation Endourology
-
Sofia, Sofia-Grad, Bulharsko, 1606
- Military Medical Academy, Department of Urology and Nephrology
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Patient age 18 years or older at the time of enrollment.
- Diagnosed with single or multiple renal calculi (including complex and staghorn calculi) or proximal ureteral stones.
- Scheduled to undergo any primary or secondary percutaneous surgical stone intervention, including standard percutaneous nephrolithotomy (PCNL) or any of its miniaturized variations (Mini-PCNL, Ultra-mini PCNL, Super-mini PCNL, or Micro-PCNL).
- Voluntarily provided written informed consent for participation and data utilization.
Exclusion Criteria:
- Patient age under 18 years.
- Patients scheduled to undergo alternative primary treatment modalities for the targeted stone burden as a standalone procedure (e.g., retrograde intrarenal surgery [RIRS] or shockwave lithotripsy [SWL]).
- Presence of an active, untreated urinary tract infection (UTI) or clinical urosepsis at the time of the scheduled surgical procedure.
- Uncorrected severe coagulopathy or uncorrectable bleeding diathesis.
- Missing, incomplete, or unavailable medical charts or follow-up records rendering outcome assessment impossible.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Percutaneous nephrolithotripsy (PCNL)
|
Patients included in this observational study undergo Percutaneous Nephrolithotomy (PCNL) for the treatment of renal calculi according to the established protocols of each participating center.
The surgical procedure involves creating a percutaneous tract to the renal collecting system under ultrasound, fluoroscopic, or combined guidance.
The study observes a wide spectrum of contemporary techniques, including standard-tract PCNL and miniaturized versions (Mini-PCNL), performed in either prone or supine positions.
Specific procedural data are recorded, including the method of tract dilation (balloon, telescopic, or single-step), the type of lithotripsy energy used (laser, ultrasonic, or pneumatic), and postoperative drainage strategies (standard nephrostomy, tubeless, or stent-only).
As an observational study, the choice of specific technique and equipment is determined by the treating surgeon based on clinical indications and institutional standards.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Primary Stone-Free Rate (SFR)
Časové okno: 1 month postoperatively.
|
The primary efficacy outcome defined as the percentage of patients achieving clinical success at the 1-month follow-up evaluation.
Stone-free status is defined as the complete absence of residual stone fragments or the presence of clinically insignificant residual fragments (CIRF) characterized as measuring $\le 3\text{ mm}$ in maximum diameter.
Efficacy and fragment clearance will be verified using the participating center's standard postoperative imaging protocols, which include kidney-ureter-bladder (KUB) radiography, renal ultrasonography, or non-contrast computed tomography (NCCT) scans.
|
1 month postoperatively.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Postoperative Complication Rate
Časové okno: Up to 30 days postoperatively
|
The incidence and severity of postoperative adverse events and complications will be systematically recorded and graded according to the standardized Clavien-Dindo classification system.
The scale ranges from Grade I (minor deviations from the normal postoperative course without need for pharmacological or surgical intervention) to Grade V (patient mortality).
The final reported metrics will include the overall percentage of patients experiencing any complication (Grades I-V) and the rate of severe major complications (defined as Clavien-Dindo Grade $\ge$ III) within the 1-month postoperative follow-up period.
|
Up to 30 days postoperatively
|
|
Perioperative Hemoglobin Drop
Časové okno: Within 24 hours postoperatively
|
The absolute change in serum hemoglobin levels measured in grams per deciliter ($g/dL$).
It is calculated as the mathematical difference between the patient's baseline preoperative hemoglobin value (obtained within 48 hours prior to surgical incision) and the lowest recorded postoperative hemoglobin value obtained within the first 24 hours following the procedure.
This metric serves as an objective surrogate marker for perioperative blood loss.
|
Within 24 hours postoperatively
|
|
Length of Hospital Stay (LOS)
Časové okno: From the day of surgery/admission until formal hospital discharge, assessed up to 14 days
|
The total duration of the inpatient hospital stay calculated in days.
The count begins on the day of the percutaneous surgical procedure and concludes on the exact date of formal medical discharge from the urology department.
A longer stay typically reflects the management of postprocedural complications or prolonged drainage requirements.
|
From the day of surgery/admission until formal hospital discharge, assessed up to 14 days
|
|
Total Operative Time
Časové okno: During the surgical procedure
|
The cumulative duration of the surgical intervention measured continuously in minutes.
The time frame is defined as the interval starting from initial patient positioning and the commencement of mandatory diagnostic cystoscopy/ureteral catheterization, up to the final secure placement of percutaneous drainage (nephrostomy tube/ureteral stent) and dressing application.
|
During the surgical procedure
|
|
Postoperative Change in Renal Function
Časové okno: Preoperatively up to 1 month postoperatively
|
The longitudinal evaluation of renal excretory capacity.
This is determined by comparing preoperative baseline blood samples with follow-up laboratory values obtained at 1 month postoperatively.
The primary markers analyzed will be serum creatinine levels ($mg/dL$ or $\mu mol/L$) and the estimated Glomerular Filtration Rate (eGFR), calculated using the standardized CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation to assess any transient or permanent functional impairment.
|
Preoperatively up to 1 month postoperatively
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Primary Percutaneous Renal Access Success Rate
Časové okno: During the surgical procedure
|
The technical success rate of gaining definitive percutaneous access into the renal collecting system.
Success is defined as the correct and safe placement of the working guidewire and the subsequent percutaneous tract sheath into the targeted renal calyx or renal pelvis, allowing for the successful introduction of the nephroscope.
This metric will evaluate and compare the efficacy of different imaging guidance modalities (pure ultrasound-guided puncture versus conventional fluoroscopy guidance versus dual/combined tactile guidance) and will be reported as the overall percentage of successfully established tracts across the treatment cohorts.
|
During the surgical procedure
|
|
Perioperative Blood Transfusion Rate
Časové okno: Up to 30 days postoperatively
|
The overall percentage of patients requiring the administration of allogeneic packed red blood cells (PRBC) or other homologous blood products during the intraoperative period or within the 30-day postoperative window.
The decision to transfuse will be based on standardized institutional clinical criteria, including an acute drop in serum hemoglobin levels (typically below $7\text{-}8\text{ g/dL}$) or the presence of clinical symptoms of severe anemia/hemodynamic instability.
This metric will be reported as a categorical outcome (transfusion required vs. not required) to evaluate the safety profile across the different PCNL tract sizes and techniques.
|
Up to 30 days postoperatively
|
|
Intraoperative Radiation Exposure Time
Časové okno: During the surgical procedure
|
The total duration of fluoroscopy utilization recorded continuously during the surgical procedure, measured in minutes (or seconds).
This metric captures the cumulative time the fluoroscopy pedal is activated to achieve renal collection system localization, guide the puncture needle, monitor tract dilatation, and verify stone clearance.
It will be utilized to quantify and compare the radiation burden between conventional fluoroscopy-guided cases, dual-guidance protocols, and pure ultrasound-guided access (where exposure time is expected to be zero).
|
During the surgical procedure
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Kemal Sarika, PhD, Sancaktepe Training and Research Hospital, Istanbul, Turkiye
- Studijní židle: Guohua Zeng, PhD, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
- Studijní židle: Simon Choong, PhD, Institute of Urology, University College London Hospitals, London, United Kingdom
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Patologické procesy
- Mužská urogenitální onemocnění
- Calculi
- Patologické stavy, anatomické
- Onemocnění ledvin
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Močové kameny
- Nefrolitiáza
- Patologické stavy, příznaky a symptomy
- Ledvinový kámen
- Pooperační komplikace
- Urolitiáza
Další identifikační čísla studie
- FoundatioEndourology
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Qualified academic researchers and clinicians with a methodologically sound research proposal that aims to advance the field of endourology and stone disease management." What: De-identified individual participant data (IPD) that underlie the results reported in the published articles, including the study protocol, statistical analysis plan (SAP), and data dictionary.
How: Proposals should be submitted directly to the corresponding author (Prof. Iliya Saltirov, saltirov@vma.bg). All requests will be reviewed by the IAU Scientific Committee to ensure ethical standards and scientific validity. To gain access, requesters must sign a formal Data Access Agreement (DAA) to protect participant confidentiality and ensure data security.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .