Study Title: Imaging-Guided Classification \& Surgical Outcomes in Endophytic Renal Tumors Study Goal: This observational study investigates whether an imaging-guided classification system improves partial nephrectomy (PN) outcomes for completely endophytic renal cell carcinoma (RCC). Main Question: Does preoperative imaging classification reduce complications (e.g., ischemia time, urinary leakage) in PN for endophytic RCC compared to traditional methods? Methods: Patients undergoing PN for endophytic RCC will be grouped based on preoperative imaging classification. Surgical outcomes (complications, renal function) will be tracked for 5 years and compared to non-classified PN cases. Significance: Aims to optimize PN planning, minimize risks, and improve long-term renal preservation in complex RCC cases
I. Background of the study Completely endogenous renal cell carcinoma (RCC) is challenging to perform partial nephrectomy (PN) due to the extensive contact area between normal renal parenchyma and RCC and the inability to accurately determine its location from the renal surface.Considering the anatomical complexity and the high risk of complications associated with PN, urologists had favored radical nephrectomy (RN) for completely endophytic RCC to mitigate complications .Advances in robotic-assisted laparoscopic surgery and the use of intraoperative ultrasound have led some clinicians to report prognostic and perioperative outcomes similar to those of RN treatment using PN for these complex endogenous RCCs .Although these studies suggest that PN is an available treatment option for fully endogenous RCC, PN treatment of fully endogenous RCC is usually associated with higher intraoperative and perioperative complications, including longer thermal ischemia time (WIT), higher rates of urinary leakage, and higher rates of positive surgical margins, when compared with PN treatment of non-endogenous RCC .Therefore, performing accurate preoperative planning is essential to help clinicians perform PN for fully endogenous RCC and to minimize associated complications. In surgery with preservation of renal units, precise preoperative assessment and personalized surgical strategies are crucial for the preservation of postoperative renal function, reduction of complications, and improvement of long-term survival of patients .Therefore, the development of an imaging-based classification system to optimize surgical techniques for completely endophytic tumors is of great clinical importance. The core objective of this study was to establish a scientific classification system for completely endophytic renal tumors through an imaging-guided preoperative classification method, to explore individualized surgical strategies for preserving renal units, and to analyze their performance in terms of postoperative clinical outcomes to provide new ideas and guidance for clinical practice .
Study Type
OBSERVATIONAL
Enrollment
190
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Surgical technique
Surgical options for completely endogenous renal cancer include laparoscopic, open, and robotic. The impact on the patient is assessed according to the different surgical modalities.
Time frame: From enrollment to the end of 4 weeks of treatment
Trifecta achievement
In renal cancer surgery (particularly partial nephrectomy), the Trifecta achievement consists of: * Negative surgical margins (no residual tumor) * No perioperative complications (e.g., hemorrhage, urinary leakage) * Preservation of renal function (minimal decline in eGFR)
Time frame: From enrollment to the end of 4 weeks of treatment
Tumour subtype on histology
The tumor subtypes of renal cancer studied in this study included clear cell carcinoma, papillary carcinoma, and smoky cell carcinoma.
Time frame: From enrollment to the end of 4 weeks of treatment
tumor size
It was used to assess the size of the tumor, and in this study, due to the endogenous nature of the tumor, the tumors were generally small, less than 5 cm
Time frame: From enrollment to the end of 4 weeks of treatment
age
Patient's age at diagnosis
Time frame: From enrollment to the end of 4 weeks of treatment
Gender
Sex of the patient, categorized as male, female.
Time frame: From enrollment to the end of 4 weeks of treatment
Tumor side
Split into left and right side.
Time frame: From enrollment to the end of 4 weeks of treatment
BMI
Body Mass Index.The formula is: BMI = weight ÷ height squared (weight in kilograms; height in meters)
Time frame: From enrollment to the end of 4 weeks of treatment
Smoking history
"0" means current or former smoker, '1' means no smoking. Used to assess whether or not one has smoked. To observe the effect on disease
Time frame: From enrollment to the end of 4 weeks of treatment
Alcohol use
"0" indicates current or previous alcohol consumption and '1' indicates no alcohol consumption. Used to assess whether or not one has been drinking. To observe the effect on disease.
Time frame: From enrollment to the end of 4 weeks of treatment
Hypertension
"0" means having or currently having high blood pressure and '1' means not having high blood pressure. It is used to assess whether or not a person has ever had a hypertensive disorder.To observe the effect on disease
Time frame: From enrollment to the end of 4 weeks of treatment
Diabetes
"0" means current or previous diabetes, '1' means no diabetes. Used to assess for a history of diabetes. To observe the effect on disease
Time frame: From enrollment to the end of 4 weeks of treatment
ECOG performance status
0 Fully normal mobility, with no difference in mobility from that before the onset of the disease. 1. Able to walk freely and engage in light physical activities, including general housework or office work, but unable to engage in heavier physical activities. 2. Able to walk freely and take care of oneself, but with loss of working ability, and can get up and move around not less than half of the time during the day. 3. Can only partially take care of oneself, and spends more than half of the day in bed or in a wheelchair. 4. Bedridden, unable to take care of themselves. 5. Death Higher scores mean worse.
Time frame: From enrollment to the end of 4 weeks of treatment
Charlson comorbidity index
Score 0: Low risk. The patient has no specific co-morbidities included in the CCI score, indicating that the patient is relatively healthy and has a high survival rate. Score 1-2: Moderate risk. Patients may have one or two milder co-morbidities, but overall risk is relatively low. Score 3-4: Moderate to high risk. Patients may have a moderate burden of co-morbidities and may have reduced survival. Score 5-6: High risk. Patients have a high burden of co-morbidities and may require closer monitoring and care. Score 7 and above: Very high risk. The patient has a more severe burden of co-morbidities and may have significantly reduced survival and a higher risk of treatment.
Time frame: From enrollment to the end of 4 weeks of treatment
ASA score
1. Physical health, good development and nutrition, normal function of organs. Perioperative mortality rate 0.06%-0.08%; 2. Mild coexisting diseases other than surgical diseases, with sound functional compensation. Perioperative mortality rate 0.27%-0.40%; 3. Severe coexisting conditions with limited physical activity, but still able to cope with daily activities. Perioperative mortality rate 1.82%-4.30%; 4. Severe coexisting conditions with loss of ability to perform daily activities and frequent life threatening situations. Perioperative mortality rate 7.80%-23.0%; 5. Dying patients who have difficulty sustaining life for 24 hours regardless of surgery. Perioperative mortality rate 9.40%-50.7%; 6. Confirmed brain death with organs intended for organ transplantation.
Time frame: From enrollment to the end of 4 weeks of treatment
P.A.D.U.A. score
The scores are 0, 1, 2, 3 and 4, ranging from "none" to "very serious", respectively.
Time frame: From enrollment to the end of 4 weeks of treatment
R.E.N.A.L. score
The R.E.N.A.L. scoring system is based on the anatomical features of renal tumors, including tumor size (R), convexity (E), relationship to the renal sinus and collecting system (N), ventral or dorsal renal location (A), location along the longitudinal axis of the kidney (L), and relationship to the renal hilum (h), and quantitatively evaluates each aspect based on the scores. Higher scores mean worse.
Time frame: From enrollment to the end of 4 weeks of treatment
operative time
The time it takes the doctor to make the cut and the time it takes to close the incision.
Time frame: From enrollment to the end of 4 weeks of treatment
estimated blood loss
By intraoperative blood loss, we actually mean loss of circulating blood volume
Time frame: From enrollment to the end of 4 weeks of treatment
warm ischemia time
The length of time between blocking the blood supply to the kidneys, the state of persistent ischemia at room temperature, and the restoration of the blood supply.
Time frame: From enrollment to the end of 4 weeks of treatment
Postoperative length of hospital stay
Length of hospitalization of patients after surgery
Time frame: From enrollment to the end of 8 weeks of treatment
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