A Study of 3D Visualization Techniques to Improve the Quality and Safety of Robot-assisted Nephro… (NCT06717009) | Clinical Trial Compass
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A Study of 3D Visualization Techniques to Improve the Quality and Safety of Robot-assisted Nephron Sparing Surgery for Complex Renal Tumors.
China350 participantsStarted 2025-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The imaging diagnosis is single renal cell carcinoma, clinical stage is T1N0M0-T2N0M0, and the contralateral kidney function is good.
. Physical status and organ function allow robotic-assisted partial nephrectomy.
. Be able to adhere to the protocol during the study.
. The age ranges from 18 to 75 years, and there is no chronic kidney disease.
. KPS \> 80; ECOG score: 0-1; There are no other serious concomitant diseases and the organ function is good.
. There are no medical contraindications seriously affecting anesthesia and surgery.
. The patient has no history of other malignant tumors in the past 5 years.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
warm ischemia time
Timeframe: From start of arterial clamping to release of arterial blocking forceps during surgery, an average of 25 minutes.
Trial details
NCT IDNCT06717009
SponsorTianjin Medical University Cancer Institute and Hospital
. There is no surgical history of epigastrium and the affected kidney.
Exclusion criteria
. Women who are pregnant or lactating, or who are of reproductive age and are not using effective contraception.
. 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
. Organ transplant recipients requiring immunosuppressive therapy.
. 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.
. Patients who have received biological therapy or other anticancer traditional Chinese medicine within 4 weeks.
. Patients with multiple or bilateral renal tumors or solitary renal tumors.