Contrast-enhanced Ultrasound and Super-resolution Imaging Predict Renal Function Outcome After Nephrectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJinling Hospital, China
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully understood and voluntarily signed the informed Consent Form (ICF);
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.
Disqualifiers
Patients with solitary kidney or severe contralateral renal insufficiency (eGFR < 15ml/min/1.73m2);
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;
Trial population
Patients scheduled for radical or partial nephrectomy who met all inclusion criteria but did not meet any exclusion criteria
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
285 Participants
are grouped into 2 trial groupsGroup A: Patients scheduled for radical nephrectomy
Group B: Patients scheduled for partial nephrectomy
Trial outcomes
Primary outcomes
1
new 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 nephrectomy2
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 nephrectomySponsors and contacts
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Source ClinicalTrials.gov