Contrast-enhanced Ultrasound and Super-resolution Imaging Predict Renal Function Outcome After Nephrectomy
NCT ID: NCT07294859
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
285 participants
OBSERVATIONAL
2025-09-01
2027-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Can quantitative parameters of renal microcirculation and microvascular structure derived from CEUS and SRI predict long-term renal function (defined as New Baseline eGFR for radical nephrectomy and Recovery from Ischemia for partial nephrectomy)? Can these imaging parameters accurately predict the occurrence, severity, and early recovery of postoperative acute kidney injury (AKI)? Researchers will monitor the dynamic evolution of renal blood flow and microvascular density by comparing the affected kidney to the contralateral healthy kidney before and after surgery to see if these biomarkers correlate with clinical outcomes.
Participants will:
Undergo CEUS and SRI examinations before surgery and at specific time points after surgery (e.g., within 7 days) to visualize renal microvasculature.
Provide blood and urine samples for standard laboratory tests (such as serum creatinine and Cystatin C) to assess kidney function during hospitalization.
Attend follow-up visits at 1, 3, 6, 9, and 12 months post-surgery to monitor long-term renal recovery and complete necessary imaging assessments (CT or Ultrasound).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The main contents of this study include: longitudinal observation of the dynamic evolution patterns of renal microcirculation parameters before and after the operation; Analyze the correlations between these imaging parameters and the occurrence, severity and prognosis of postoperative acute kidney injury, and simultaneously explore the association between the occurrence and development of early AKI and long-term renal function changes; Ultimately, the goal is to combine predictive imaging parameters with traditional clinical variables (such as age, preoperative renal function, etc.) to construct integrated mathematical models for different surgical methods (partial nephrectomy and radical nephrectomy), in order to accurately predict the early (postoperative acute kidney injury) and long-term renal function (such as new baseline estimated glomerular filtration rate) of patients. Meanwhile, considering the compensatory function of contralateral renal function after PN, Rec-Ischemia was adopted as the primary endpoint indicator to evaluate the changes of ipsilateral postoperative renal function in patients after PN. This study is expected to provide innovative imaging biomarkers and decision support for individualized management and early intervention of renal function after nephrectomy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients scheduled for radical nephrectomy
No interventions assigned to this group
Patients scheduled for partial nephrectomy
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age: \> 18 (at the time of signing the informed consent form); Gender is not limited.
* Preoperative eGFR \> 45ml/min/1.73m2 (corrected CKD-EPI formula);
* After the clinician formulates the treatment plan and communicates with the patient, they decide whether to perform radical nephrectomy or partial nephrectomy.
* ECOG score: 0-2 points;
* Be willing and able to abide by the visits, treatments, laboratory tests and other procedures of the research plan.
Exclusion Criteria
* Preoperative reliance on renal replacement therapy (such as dialysis, etc.);
* Those who fail to complete the nephrectomy as planned during the operation;
* Patients with lymph node metastasis, distant metastasis or venous tumor thrombus;
* The healthy kidney has undergone radiotherapy, ablation or other surgeries.
* Have a history of allergy to ultrasound contrast agents;
* Have any contraindications for contrast-enhanced ultrasound, such as right-to-left shunt, severe pulmonary hypertension, etc.
* Patients with hemodynamic instability, including those with persistent hypotension (blood pressure \< 90/60 MMHG), uncontrollable heart failure, active bleeding (such as gastrointestinal and cerebral hemorrhage, etc.), or those with a bleeding tendency and hemoglobin \< 60g/L and/or platelet count \< 50×109/L;
* Accompanied by structural abnormalities of the urinary system or functional abnormalities that cannot be corrected in a short time (such as duplicate kidneys, polycystic kidneys, horseshoe kidneys, isolated kidneys, renal artery stenosis \> 50%, urinary tract obstruction, and previous history of kidney surgery, etc.), long-term indwelling of urinary catheters, etc.
* There are other diseases that limit life expectancy to less than six months;
* Previous (≤30 days before randomization) or concurrent participation in another clinical study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jinling Hospital, China
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Le Qu
Associate chief urologist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Le Qu
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DZQH-KYLL-25-37
Identifier Type: -
Identifier Source: org_study_id