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Not Yet Recruiting NCT07816991

Real-World Study of Obstructive Upper Urinary Tract Stones and Acute Pyelonephritis

Conditions: Urolithiasis, Strategy Training, Observation, Pyelonephritis Acute

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1650
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Summary

Upper urinary tract stone obstruction complicated by acute pyelonephritis is a critical urological emergency requiring urgent decompression and infection control, yet real-world clinical decisions regarding the choice between retrograde ureteral stenting, percutaneous nephrostomy, or initial antibiotic therapy often vary based on physician experience and resource availability. This prospective, multi-center, observational study aims to enroll 1,650 patients across more than 30 hospitals in China to systematically evaluate the technical success rates, infection control efficacy, and safety profiles of these different management strategies. By analyzing natural clinical cohorts without intervening in routine practice, the study seeks to define the optimal application boundaries for retrograde stenting, evaluate the role of nephrostomy as a primary or salvage treatment, and establish risk models to predict the failure of conservative antibiotic therapy, ultimately providing high-level evidence for individualized and precise clinical decision-making.

Eligibility Criteria

Inclusion Criteria: * Informed consent has been obtained from the patient. * Unilateral upper urinary tract stone obstruction (accompanied by dilatation of the renal pelvis and/or ureter) confirmed by non-contrast CT (NCCT). * Presence of fever (body temperature ≥38.0°C) and/or chills. * Meet at least one of the following conditions: * SIRS Criteria: Meeting at least two of the following: heart rate \>90 bpm; respiratory rate \>20 breaths/min; white blood cell count \>12×10⁹/L or \

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Source: ClinicalTrials.gov (NCT07816991). StuddyBuddy aggregates publicly available trial information.