NCT06717009Not yet recruiting
A Study of 3D Visualization Techniques to Improve the Quality and Safety of Robot-assisted Nephron Sparing Surgery for Complex Renal Tumors.
A Prospective, Multicenter, Randomized Controlled Study of Three-dimensional Visualization Techniques to Improve the Quality and Safety of Robot-assisted Nephron Sparing Surgery for Complex Renal Tumors
Source: ClinicalTrials.gov · Last updated 4 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 24 Nov 2024
- Start date
- Jan 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT06717009
What you commit to
- Study type: Interventional
- Planned participants: 350
- From Jan 2025 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Organ transplant recipients requiring immunosuppressive therapy.
- Patients who have received biological therapy or other anticancer traditional Chinese medicine within 4 weeks.
Other illness
- 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
- 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.
Age
- Women who are pregnant or lactating, or who are of reproductive age and are not using effective contraception.
Other
- Patients with multiple or bilateral renal tumors or solitary renal tumors.
- Patient without complete clinical information.
Who the study is looking for
- 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.
- There is no surgical history of epigastrium and the affected kidney.
- Estimated survival is more than 6 months, and there are no other severe diseases that reduce survival to less than 5 years.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.