IAU Percutaneous Nephrolithotripsy Study

NCT07622238 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2026-06-03

No results posted yet for this study

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

  • Urolithiasis
  • Kidney Calculi

Interventions

PROCEDURE

Percutaneous nephrolithotomi (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.

Sponsors & Collaborators

  • The International Alliance of Urolithiasis

    collaborator NETWORK
  • Foundation Endourology

    lead OTHER

Principal Investigators

  • Kemal Sarika, PhD · Sancaktepe Training and Research Hospital, Istanbul, Turkiye

  • Guohua Zeng, PhD · The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

  • Simon Choong, PhD · Institute of Urology, University College London Hospitals, London, United Kingdom

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2026-06-15
Completion
2026-06-15

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07622238 on ClinicalTrials.gov