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

10. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

1650

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Ureteral Stent (RUS) Group
Retrograde placement of a ureteral stent via the transurethral approach to relieve the obstruction
Verfahren: 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.
Verfahren: 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.
Arzneimittel: Initial Medical Therapy
Conservative management with initial antimicrobial therapy to control infection, without immediate surgical drainage.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Technical Success Rate of Retrograde Ureteral Stenting
Zeitfenster: Perioperative/Periprocedural
Defined as successful retrograde placement of a ureteral stent into the renal pelvis, verified by postoperative imaging for correct positioning.
Perioperative/Periprocedural

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to Clinical Stability
Zeitfenster: 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:
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From admission (baseline) to discharge (up to 30 days)
From admission (baseline) to discharge (up to 30 days)
ICU admission rate and duration
Zeitfenster: From admission to discharge (up to 30 days)
From admission to discharge (up to 30 days)
Total medical expenditures during hospitalization.
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: From admission (baseline) to discharge (up to 30 days)
From admission (baseline) to discharge (up to 30 days)
Urinary ultrasound findings
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2029

Studienabschluss (Geschätzt)

1. November 2029

Studienanmeldedaten

Zuerst eingereicht

30. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. September 2026

Zuerst gepostet (Tatsächlich)

14. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 20260830

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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