Real-World Study of Obstructive Upper Urinary Tract Stones and Acute Pyelonephritis
10 сентября 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Наблюдательный
Регистрация (Оцененный)
1650
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Yi Shao
- Номер телефона: 021-63240090
- Электронная почта: drshaoyi@163.com
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
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.
Описание
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).
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Technical Success Rate of Retrograde Ureteral Stenting
Временное ограничение: Perioperative/Periprocedural
|
Defined as successful retrograde placement of a ureteral stent into the renal pelvis, verified by postoperative imaging for correct positioning.
|
Perioperative/Periprocedural
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Time to Clinical Stability
Временное ограничение: 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:
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: From admission (baseline) to discharge (up to 30 days)
|
From admission (baseline) to discharge (up to 30 days)
|
|
|
ICU admission rate and duration
Временное ограничение: From admission to discharge (up to 30 days)
|
From admission to discharge (up to 30 days)
|
|
|
Total medical expenditures during hospitalization.
Временное ограничение: 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
Временное ограничение: 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.
Временное ограничение: From admission (baseline) to discharge (up to 30 days)
|
From admission (baseline) to discharge (up to 30 days)
|
|
|
Urinary ultrasound findings
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 октября 2026 г.
Первичное завершение (Оцененный)
1 октября 2029 г.
Завершение исследования (Оцененный)
1 ноября 2029 г.
Даты регистрации исследования
Первый отправленный
30 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
10 сентября 2026 г.
Первый опубликованный (Действительный)
14 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
14 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
10 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Мужские мочеполовые заболевания
- Урологические заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Мочекаменная болезнь
- Диагностические методы и процедуры
- Диагноз
- Хирургические процедуры, оперативные
- Урологические хирургические процедуры
- Урогенитальные хирургические процедуры
- Диагностические методы, урологические
- Остомия
- Отведение мочи
- Nephrotomy
- Nephrostomy, Percutaneous
Другие идентификационные номера исследования
- 20260830
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .