IAU Percutaneous Nephrolithotripsy Study

NCT07622238 | Recruiting DMC

• 1 other identifier: FoundatioEndourology
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Kidney Calculi; Urolithiasis

Keywords

Percutaneous Nephrolithotomy; Standart PCNL; Mini-PCNL; Urolithiasis; Kidney Stones; Postoperative Complications; Efficacy

Outcome Measures

Primary Outcomes (1)

• Primary Stone-Free Rate (SFR)

  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.

Secondary Outcomes (5)

• Postoperative Complication Rate

  Up to 30 days postoperatively

• Perioperative Hemoglobin Drop

  Within 24 hours postoperatively

• Length of Hospital Stay (LOS)

  From the day of surgery/admission until formal hospital discharge, assessed up to 14 days

• Total Operative Time

  During the surgical procedure

• Postoperative Change in Renal Function

  Preoperatively up to 1 month postoperatively

Other Outcomes (3)

• Primary Percutaneous Renal Access Success Rate

  During the surgical procedure

• Perioperative Blood Transfusion Rate

  Up to 30 days postoperatively

• Intraoperative Radiation Exposure Time

  During the surgical procedure

Study Arms (1)

Percutaneous nephrolithotripsy (PCNL)

Percutaneous nephrolithotripsy (PCNL)

Procedure: Percutaneous nephrolithotomi (PCNL)

Interventions

Percutaneous nephrolithotomi (PCNL) PROCEDURE

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.

Also known as: PCNL, mini PCNL

Percutaneous nephrolithotripsy (PCNL)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of consecutive adult patients (18 years or older) diagnosed with renal or proximal ureteral calculi who are candidates for percutaneous stone surgery and are treated in real-world clinical practice settings. Participants are enrolled across 21 participating secondary and tertiary referral academic medical centers and hospitals globally, capturing a highly diverse and heterogeneous international population across multiple geographic regions

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation Endourology: lead
• The International Alliance of Urolithiasis: collaborator

Study Sites (4)

Foundation Endourology

Sofia, Sofia-Grad, 1606, Bulgaria

RECRUITING

Foundation Endourology

Sofia, Sofia-Grad, 1606, Bulgaria

RECRUITING

Foundation Endourology

Sofia, Sofia-Grad, 1606, Bulgaria

RECRUITING

Military Medical Academy, Department of Urology and Nephrology

Sofia, Sofia-Grad, 1606, Bulgaria

RECRUITING

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi; Postoperative Complications

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Kemal Sarika, PhD

  Sancaktepe Training and Research Hospital, Istanbul, Turkiye

  STUDY CHAIR

• Guohua Zeng, PhD

  The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

  STUDY CHAIR

• Simon Choong, PhD

  Institute of Urology, University College London Hospitals, London, United Kingdom

  STUDY CHAIR

Central Study Contacts

Iliya P Saltirov, DSc

CONTACT

+359888723744; iliya.saltirov@gmail.com

Ognyan H Gatsev, PhD

CONTACT

+359883490750; gatsev@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 3, 2026
• Study Start: August 15, 2019
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication of the primary manuscript 36 months after publication.
• Access Criteria: 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.

Locations

BU (4)