Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

10. september 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1650

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Clinical Stability
Tidsramme: 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:
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From admission (baseline) to discharge (up to 30 days)
From admission (baseline) to discharge (up to 30 days)
ICU admission rate and duration
Tidsramme: From admission to discharge (up to 30 days)
From admission to discharge (up to 30 days)
Total medical expenditures during hospitalization.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: From admission (baseline) to discharge (up to 30 days)
From admission (baseline) to discharge (up to 30 days)
Urinary ultrasound findings
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. oktober 2029

Studieafslutning (Anslået)

1. november 2029

Datoer for studieregistrering

Først indsendt

30. august 2026

Først indsendt, der opfyldte QC-kriterier

10. september 2026

Først opslået (Faktiske)

14. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20260830

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner