UrolithiasisNCT07816991
Real-World Study of Obstructive Upper Urinary Tract Stones and Acute Pyelonephritis
An observational study of Urolithiasis and Strategy Training, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Strategy Training, Observation
- What is being tested?
- Ureteral Stent, Percutaneous Nephrostomy and Initial Medical Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,650 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Urolithiasis, Strategy Training, Observation, Pyelonephritis Acute
- Being tested
- Ureteral Stent, Percutaneous Nephrostomy, Initial Medical Therapy
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteral StentProcedure or surgery
Retrograde placement of a ureteral stent via the transurethral approach to relieve the obstruction.
Percutaneous NephrostomyProcedure or surgery
Placement of a nephrostomy tube via percutaneous access to provide drainage and relieve the obstruction.
Initial Medical TherapyDrug
Conservative management with initial antimicrobial therapy to control infection, without immediate surgical drainage.
| Study group | Role | What they receive |
|---|---|---|
| Ureteral Stent (RUS) Group | Retrograde placement of a ureteral stent via the transurethral approach to relieve the obstruction Receives: Procedure: Ureteral Stent | |
| Percutaneous Nephrostomy (PCN) Group | Placement of a nephrostomy tube via percutaneous access to provide drainage and relieve the obstruction. Receives: Procedure: Percutaneous Nephrostomy | |
| Initial Medical Therapy Group | Conservative management with initial antimicrobial therapy to control infection, without immediate surgical drainage. Receives: Drug: Initial Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success Rate of Retrograde Ureteral Stenting
Defined as successful retrograde placement of a ureteral stent into the renal pelvis, verified by postoperative imaging for correct positioning.
Measured: Perioperative/Periprocedural
Secondary outcomes (12)
Time to Clinical Stability
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.
Measured: 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:
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.
Measured: within 30 days
Proportion of Salvage Treatment
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.
Measured: Day 1 After Initial Medical Therapy
Failure of 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.
Measured: Day 1 After Initial Medical Therapy
Total length of hospital stay
Measured: From admission to discharge (up to 30 days)
The change in serum creatinine from baseline to discharge
Measured: From admission (baseline) to discharge (up to 30 days)
ICU admission rate and duration
Measured: From admission to discharge (up to 30 days)
Total medical expenditures during hospitalization.
Measured: From admission to discharge (up to 30 days)
the minimum estimated glomerular filtration rate (eGFR) recorded during the hospital stay
Measured: From admission to discharge (up to 30 days)
the proportion of patients experiencing a ≥25% decrease in eGFR at discharge compared to baseline.
Measured: From admission (baseline) to discharge (up to 30 days)
Urinary ultrasound findings
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.
Measured: at 3 months (±7 days) post-discharge
Serum creatinine levels
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.
Measured: at 3 months (±7 days) post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,650 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Shao, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816991
- Sponsor's protocol ID
- 20260830
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Study on Management Strategies for Upper Urinary Tract Stone Obstruction Complicated by Acute Pyelonephritis
- ClinicalTrials.gov ID
- NCT07816991
- Acronym / sponsor ID
- 20260830
- Conditions
- Urolithiasis, Strategy Training, Observation, Pyelonephritis Acute
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ureteral Stent (RUS) Group | – | Procedure: Ureteral StentRetrograde placement of a ureteral stent via the transurethral approach to relieve the obstruction |
| Percutaneous Nephrostomy (PCN) Group | – | Procedure: Percutaneous NephrostomyPlacement of a nephrostomy tube via percutaneous access to provide drainage and relieve the obstruction. |
| Initial Medical Therapy Group | – | Drug: Initial Medical TherapyConservative management with initial antimicrobial therapy to control infection, without immediate surgical drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ureteral StentRetrograde placement of a ureteral stent via the transurethral approach to relieve the obstruction. | Procedure or surgery | Ureteral Stent (RUS) Group |
| Percutaneous NephrostomyPlacement of a nephrostomy tube via percutaneous access to provide drainage and relieve the obstruction. | Procedure or surgery | Percutaneous Nephrostomy (PCN) Group |
| Initial Medical TherapyConservative management with initial antimicrobial therapy to control infection, without immediate surgical drainage. | Drug | Initial Medical Therapy Group |
Primary outcome
Technical Success Rate of Retrograde Ureteral Stenting
Time frame: Perioperative/Periprocedural
Defined as successful retrograde placement of a ureteral stent into the renal pelvis, verified by postoperative imaging for correct positioning.
12 secondary outcomes
Time to Clinical Stability
Time frame: 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:
Time frame: within 30 days
Proportion of Salvage Treatment
Time frame: Day 1 After Initial Medical Therapy
Failure of Initial Medical Therapy
Time frame: Day 1 After Initial Medical Therapy
Total length of hospital stay
Time frame: From admission to discharge (up to 30 days)
The change in serum creatinine from baseline to discharge
Time frame: From admission (baseline) to discharge (up to 30 days)
ICU admission rate and duration
Time frame: From admission to discharge (up to 30 days)
Total medical expenditures during hospitalization.
Time frame: From admission to discharge (up to 30 days)
the minimum estimated glomerular filtration rate (eGFR) recorded during the hospital stay
Time frame: From admission to discharge (up to 30 days)
the proportion of patients experiencing a ≥25% decrease in eGFR at discharge compared to baseline.
Time frame: From admission (baseline) to discharge (up to 30 days)
Urinary ultrasound findings
Time frame: at 3 months (±7 days) post-discharge
Serum creatinine levels
Time frame: at 3 months (±7 days) post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis and Strategy Training, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Shao (021-63240090, drshaoyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success Rate of Retrograde Ureteral Stenting (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.