Preoperative three-dimensional reconstruction: On the basis of conventional CT/MRI, the patient will undergo 3D reconstruction within 48 hours before surgery. The surgeon/researcher will conduct surgical planning according to the results of the 3D reconstruction and perform robot-assisted laparoscopic nephron sparing surgery.
Study summary
The goal of this clinical trial is to learn the evidence-based medical value of 3D visualization techniques to improve tumor control, preservation of renal function, and perioperative safety in robot-assisted nephron sparing surgery for complex renal tumors. The main question it aims to answer is:
Is 3D visualization techniques more effective in improving robot-assisted nephron sparing surgery for complex renal tumors in terms of tumor control, renal function preservation, and perioperative safety.
The researchers will randomize participants into a 3D trial group and a conventional group for comparison.
Participants will:
Complete Blood routine, liver and kidney function tests on the first and third day after operation.
Have Renography at 3 and 12 months after the operation. Cooperate with follow-up visits.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. The imaging diagnosis is single renal cell carcinoma, clinical stage is T1N0M0-T2N0M0, and the contralateral kidney function is good.
2. Physical status and organ function allow robotic-assisted partial nephrectomy.
3. Be able to adhere to the protocol during the study.
4. The age ranges from 18 to 75 years, and there is no chronic kidney disease.
5. KPS \> 80; ECOG score: 0-1; There are no other serious concomitant diseases and the organ function is good.
6. There are no medical contraindications seriously affecting anesthesia and surgery.
7. The patient has no history of other malignant tumors in the past 5 years.
8. There is no surgical history of epigastrium and the affected kidney.
9. Estimated survival is more than 6 months, and there are no other severe diseases that reduce survival to less than 5 years.
Exclusion Criteria:
1. Women who are pregnant or lactating, or who are of reproductive age and are not using effective contraception.
2. Comorbid serious medical diseases or conditions, for example, clinically severe or active heart disease, severe uncontrolled medical illnesses and infections, severe uncontrolled digestive disorder, severe electrolyte disturbance, active disseminated intravascular coagulation, major organ failure such as decompensated cardiac, pulmonary, hepatic, or renal failure, symptomatic peripheral neuropathy. Can not tolerate robot-assisted laparoscopic partial nephrectomy
3. Organ transplant recipients requiring immunosuppressive therapy.
4. There is history of other malignancies within 5 years of trial initiation, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
5. Patients who have received biological therapy or other anticancer traditional Chinese medicine within 4 weeks.
6. Patients with multiple or bilateral renal tumors or solitary renal tumors.
7. Patient without complete clinical information.
Primary outcome measure(s)
warm ischemia time — From start of arterial clamping to release of arterial blocking forceps during surgery, an average of 25 minutes. The time from start of arterial clamping to release of arterial blocking forceps during surgery. Superselective arterial blockade will be recorded separately as a specific blockade modality. The arterial blocking time will be recorded as 0 for those without arterial blockage.
Trial sites (1)
Facility
City
Region
Status
Tianjin Medical University Cancer Institute and Hospital
Tianjin
China
More Tianjin Medical University Cancer Institute and Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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