Real-World Study of Obstructive Upper Urinary Tract Stones and Acute Pyelonephritis
10 de septiembre de 2026 actualizado por: Yi Shao, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Real-World Study on Management Strategies for Upper Urinary Tract Stone Obstruction Complicated by Acute Pyelonephritis
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Although current clinical consensus suggests that both percutaneous nephrostomy and retrograde ureteral stenting are effective for decompressing the upper urinary tract, real-world data suggest that retrograde stenting is chosen in the vast majority of cases due to its minimally invasive nature, leaving a critical knowledge gap regarding its specific failure risk factors and the precise indications for primary nephrostomy. Furthermore, a subset of patients who meet drainage criteria are initially treated with antibiotics alone due to non-medical factors such as patient preference or resource constraints, but the safety and failure boundaries of this conservative approach have not been well-documented. This study is designed as a prospective observational cohort study where 1,650 patients will be naturally assigned to treatment cohorts based on the initial clinical decision, including initial retrograde stenting, initial nephrostomy, or initial antibiotic therapy. Participants must present with CT-confirmed unilateral stone obstruction, fever or chills, and signs of systemic inflammation or organ dysfunction to ensure a well-defined study population.
The researchers will record detailed baseline data including stone characteristics, infection severity scores, and a unique physician-based subjective risk assessment to capture the nuances of clinical decision-making logic in real-time. The primary endpoint is the technical success rate of retrograde ureteral stenting, while secondary endpoints include the time to clinical stability, 30-day major complication rates, salvage treatment requirements, and renal function recovery metrics measured by creatinine and glomerular filtration rate changes. To address the expected sample size imbalance between treatment groups, the statistical analysis plan will utilize propensity score matching and inverse probability of treatment weighting to ensure robust comparisons. Ultimately, the study will develop visualization tools such as nomograms to predict the failure of retrograde stenting and conservative treatment, bridging the gap between clinical guidelines and real-world emergency management to improve patient safety and resource allocation.
Tipo de estudio
De observación
Inscripción (Estimado)
1650
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yi Shao
- Número de teléfono: 021-63240090
- Correo electrónico: drshaoyi@163.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
The study population consists of adult patients presenting to emergency or urology departments with acute pyelonephritis secondary to unilateral upper urinary tract stone obstruction.
This group represents a clinically high-risk population in the real-world setting, characterized by the presence of both mechanical urinary obstruction (confirmed by imaging) and systemic inflammatory responses.
By including patients with symptoms ranging from localized flank pain to systemic markers such as SIRS or qSOFA abnormalities, the cohort encompasses the full clinical spectrum of obstructive pyelonephritis, from early-stage infection to the initial signs of urosepsis.
The population reflects real-world clinical practice where urgent decisions must be made between retrograde stenting, percutaneous nephrostomy, or initial conservative medical management.
Descripción
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 <4×10⁹/L.
- Flank or Abdominal Pain: Persistent dull pain or colic in the flank or upper abdomen on the affected side.
- qSOFA Abnormality: Meeting at least one of the following: altered mental status; systolic blood pressure <100 mmHg; respiratory rate ≥22 breaths/min.
Exclusion Criteria:
- Pregnant or lactating women.
- Non-calculous obstruction (e.g., tumors, retroperitoneal fibrosis, congenital stenosis).
- Any form of drainage or surgical treatment performed on the affected kidney for the target stone prior to admission.
- Concurrent abdominal or pelvic emergency requiring urgent surgery.
- Non-functional affected kidney (preoperative imaging suggesting renal cortical thickness <5 mm or clinical assessment of no renal function).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Ureteral Stent (RUS) Group
Retrograde placement of a ureteral stent via the transurethral approach to relieve the obstruction
|
Retrograde placement of a ureteral stent via the transurethral approach to relieve the obstruction.
|
|
Percutaneous Nephrostomy (PCN) Group
Placement of a nephrostomy tube via percutaneous access to provide drainage and relieve the obstruction.
|
Placement of a nephrostomy tube via percutaneous access to provide drainage and relieve the obstruction.
|
|
Initial Medical Therapy Group
Conservative management with initial antimicrobial therapy to control infection, without immediate surgical drainage.
|
Conservative management with initial antimicrobial therapy to control infection, without immediate surgical drainage.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Technical Success Rate of Retrograde Ureteral Stenting
Periodo de tiempo: Perioperative/Periprocedural
|
Defined as successful retrograde placement of a ureteral stent into the renal pelvis, verified by postoperative imaging for correct positioning.
|
Perioperative/Periprocedural
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to Clinical Stability
Periodo de tiempo: from the initiation of the assigned treatment until all the following criteria are met and maintained for a period of 24 hours
|
The duration (in hours) from the initiation of the assigned treatment until all the following criteria are met and maintained for a period of 24 hours: body temperature <37.3°C, heart rate <90 beats/min, respiratory rate <20 breaths/min, and systolic blood pressure ≥90 mmHg.
|
from the initiation of the assigned treatment until all the following criteria are met and maintained for a period of 24 hours
|
|
Incidence of Major Complications:
Periodo de tiempo: within 30 days
|
The occurrence of any of the following events within 30 days: septic shock; new-onset organ failure (requiring mechanical ventilation or vasopressors); major hemorrhage requiring intervention (hemoglobin decrease >2 g/dL, or requiring blood transfusion, interventional radiology, or surgery); and serious complications related to the drainage procedure.
|
within 30 days
|
|
Proportion of Salvage Treatment
Periodo de tiempo: Day 1 After Initial Medical Therapy
|
The proportion of patients converted to PCN after initial RUS failure, and the proportion of patients converted to invasive drainage (either RUS or PCN) following the failure of initial medical therapy.
|
Day 1 After Initial Medical Therapy
|
|
Failure of Initial Medical Therapy
Periodo de tiempo: Day 1 After Initial Medical Therapy
|
Defined as the requirement for emergency conversion to PCN or RUS due to any of the following: occurrence of septic shock (requiring vasopressors); peak body temperature failing to show a downward trend or procalcitonin (PCT) levels increasing by >20% within 48 hours despite adequate anti-infective treatment; patient's request for intervention due to unbearable pain or worsening infection symptoms; or development of new organ dysfunction.
|
Day 1 After Initial Medical Therapy
|
|
Total length of hospital stay
Periodo de tiempo: From admission to discharge (up to 30 days)
|
From admission to discharge (up to 30 days)
|
|
|
The change in serum creatinine from baseline to discharge
Periodo de tiempo: From admission (baseline) to discharge (up to 30 days)
|
From admission (baseline) to discharge (up to 30 days)
|
|
|
ICU admission rate and duration
Periodo de tiempo: From admission to discharge (up to 30 days)
|
From admission to discharge (up to 30 days)
|
|
|
Total medical expenditures during hospitalization.
Periodo de tiempo: From admission to discharge (up to 30 days)
|
From admission to discharge (up to 30 days)
|
|
|
the minimum estimated glomerular filtration rate (eGFR) recorded during the hospital stay
Periodo de tiempo: From admission to discharge (up to 30 days)
|
From admission to discharge (up to 30 days)
|
|
|
the proportion of patients experiencing a ≥25% decrease in eGFR at discharge compared to baseline.
Periodo de tiempo: From admission (baseline) to discharge (up to 30 days)
|
From admission (baseline) to discharge (up to 30 days)
|
|
|
Urinary ultrasound findings
Periodo de tiempo: at 3 months (±7 days) post-discharge
|
In participating centers with follow-up capacity, serum creatinine levels and urinary ultrasound findings (to assess changes in renal parenchymal thickness) will be collected at 3 months (±7 days) post-discharge.
These data will be used for exploratory analysis and will not be included in the derivation of the primary conclusions.
|
at 3 months (±7 days) post-discharge
|
|
Serum creatinine levels
Periodo de tiempo: at 3 months (±7 days) post-discharge
|
In participating centers with follow-up capacity, serum creatinine levels and urinary ultrasound findings (to assess changes in renal parenchymal thickness) will be collected at 3 months (±7 days) post-discharge.
These data will be used for exploratory analysis and will not be included in the derivation of the primary conclusions.
|
at 3 months (±7 days) post-discharge
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de octubre de 2029
Finalización del estudio (Estimado)
1 de noviembre de 2029
Fechas de registro del estudio
Enviado por primera vez
30 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Publicado por primera vez (Actual)
14 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Urolitiasis
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Procedimientos quirúrgicos, operativo
- Procedimientos quirúrgicos urológicos
- Procedimientos quirúrgicos urogenitales
- Técnicas de diagnóstico, urológicos
- Ostomía
- Derivación urinaria
- Nephrotomy
- Nephrostomy, Percutaneous
Otros números de identificación del estudio
- 20260830
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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