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

10 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

1650

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Ureteral Stent (RUS) Group
Retrograde placement of a ureteral stent via the transurethral approach to relieve the obstruction
Procedura: Ureteral Stent
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.
Procedura: Percutaneous Nephrostomy
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.
Droga: Initial Medical Therapy
Conservative management with initial antimicrobial therapy to control infection, without immediate surgical drainage.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Technical Success Rate of Retrograde Ureteral Stenting
Lasso di tempo: Perioperative/Periprocedural
Defined as successful retrograde placement of a ureteral stent into the renal pelvis, verified by postoperative imaging for correct positioning.
Perioperative/Periprocedural

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Clinical Stability
Lasso di tempo: 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:
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From admission (baseline) to discharge (up to 30 days)
From admission (baseline) to discharge (up to 30 days)
ICU admission rate and duration
Lasso di tempo: From admission to discharge (up to 30 days)
From admission to discharge (up to 30 days)
Total medical expenditures during hospitalization.
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: From admission (baseline) to discharge (up to 30 days)
From admission (baseline) to discharge (up to 30 days)
Urinary ultrasound findings
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 ottobre 2029

Completamento dello studio (Stimato)

1 novembre 2029

Date di iscrizione allo studio

Primo inviato

30 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 settembre 2026

Primo Inserito (Effettivo)

14 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 20260830

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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