The goal of this prospective cohort study is to evaluate the predictive value of Contrast-Enhanced Ultrasound (CEUS) and Super-Resolution Imaging (SRI) technologies regarding renal function outcomes in patients with renal cell carcinoma (RCC) undergoing partial or radical nephrectomy. The main questions it aims to answer are: 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).
This study is a prospective cohort study aimed at evaluating the predictive value of contrast-enhanced ultrasound and super-resolution imaging techniques for renal function outcomes in patients after nephrectomy. The study intends to include approximately 285 patients with renal cell carcinoma who are scheduled to undergo partial nephrectomy or radical nephrectomy. The core of this study is to non-invasive and quantitatively monitor the microcirculation perfusion (such as hemodynamic parameters) and microvascular structure (such as microvascular density and glomerular density) of the affected and healthy kidneys at multiple time points before and after the operation by applying contrast-enhanced ultrasound and super-resolution imaging techniques, and simultaneously collect clinical data. 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.
Study Type
OBSERVATIONAL
Enrollment
285
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China
RECRUITINGnew baseline estimates glomerular filtration rate(NB-eGFR)
NB-eGFR is defined as multiple eGFR tests conducted within 3 to 12 months after surgery, and the last eGFR measurement value within this time window (the calculation of eGFR uses the corrected CKD-EPI formula)
Time frame: 12 months after nephrectomy
Rec-Ischemia
This outcome is mainly applicable to patients undergoing partial nephrectomy. It is defined as the ratio of the ipsilateral GFR retention rate to the renal parenchymal retention rate (PPVP), that is, the degree of functional recovery of the retained renal parenchyma per unit. The calculation formula is Rec-Ischemia= ipsilateral GFR retention rate /PPVP×100%13. Ipsilateral GFR retention rate = postoperative ipsilateral GFR/ preoperative ipsilateral GFR×100%, PPVP= postoperative ipsilateral renal parenchymal volume/preoperative ipsilateral renal parenchymal volume ×100%. The predicted ipsilateral GFR after surgery = the total postoperative GFR× the expected retained SRF of the affected kidney. The expected retained SRF of the affected kidney = the parenchymal volume of the affected kidney/(the parenchymal volume of the affected kidney + the parenchymal volume of the contralateral kidney).
Time frame: 12 months after partial nephrectomy
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