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

2026년 9월 10일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

1650

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Ureteral Stent (RUS) Group
Retrograde placement of a ureteral stent via the transurethral approach to relieve the obstruction
절차: 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.
절차: 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.
의약품: Initial Medical Therapy
Conservative management with initial antimicrobial therapy to control infection, without immediate surgical drainage.

연구는 무엇을 측정합니까?

주요 결과 측정

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

2차 결과 측정

결과 측정
측정값 설명
기간
Time to Clinical Stability
기간: 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:
기간: 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
기간: 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
기간: 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
기간: 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
기간: From admission (baseline) to discharge (up to 30 days)
From admission (baseline) to discharge (up to 30 days)
ICU admission rate and duration
기간: From admission to discharge (up to 30 days)
From admission to discharge (up to 30 days)
Total medical expenditures during hospitalization.
기간: 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
기간: 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.
기간: From admission (baseline) to discharge (up to 30 days)
From admission (baseline) to discharge (up to 30 days)
Urinary ultrasound findings
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2029년 10월 1일

연구 완료 (추정된)

2029년 11월 1일

연구 등록 날짜

최초 제출

2026년 8월 30일

QC 기준을 충족하는 최초 제출

2026년 9월 10일

처음 게시됨 (실제)

2026년 9월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 10일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 20260830

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