Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Imaging, Three-Dimensional / Methods | — | UNRESOLVED | — |
| Kidney Neoplasms / Surgery | Kidney Neoplasm | PROBABILISTIC | 0.70 |
| Nephrectomy / Methods | — | UNRESOLVED | — |
| Robotic Surgical Procedures | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative three-dimensional reconstruction | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 3D trial group
- description
- The three-dimensional reconstruction data of patients will be synthesized according to renal enhanced CT/MRI within 48 hours before surgery. The surgeon/researcher will conduct surgical planning according to the results of the three-dimensional reconstruction and perform robot-assisted laparoscopic nephron sparing surgery.
- interventionNames
- Diagnostic Test: Preoperative three-dimensional reconstruction
- type
- NO_INTERVENTION
- label
- Conventional group
- description
- The patients will not undergo preoperative 3D reconstruction. The surgeon will arrange robot-assisted laparoscopic nephron sparing surgery according to routine CT/MRI.
Primary outcomes (1)
- measure
- warm ischemia time
- timeFrame
- From start of arterial clamping to release of arterial blocking forceps during surgery, an average of 25 minutes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDChen XS, Zhang ZT, Du J, Bi XC, Sun G, Yao X. Optimal surgical margin in nephron-sparing surgery for T1b renal cell carcinoma. Urology. 2012 Apr;79(4):836-9. doi: 10.1016/j.urology.2011.11.023. Epub 2012 Feb 2. PMID 22305422
- BACKGROUNDPiramide F, Kowalewski KF, Cacciamani G, Rivero Belenchon I, Taratkin M, Carbonara U, Marchioni M, De Groote R, Knipper S, Pecoraro A, Turri F, Dell'Oglio P, Puliatti S, Amparore D, Volpi G, Campi R, Larcher A, Mottrie A, Breda A, Minervini A, Ghazi A, Dasgupta P, Gozen A, Autorino R, Fiori C, Di Dio M, Gomez Rivas J, Porpiglia F, Checcucci E; European Association of Urology Young Academic Urologists and the European Section of Uro-Technology. Three-dimensional Model-assisted Minimally Invasive Partial Nephrectomy: A Systematic Review with Meta-analysis of Comparative Studies. Eur Urol Oncol. 2022 Dec;5(6):640-650. doi: 10.1016/j.euo.2022.09.003. Epub 2022 Oct 7. PMID 36216739
- BACKGROUNDAmparore D, Pecoraro A, Checcucci E, Piramide F, Verri P, De Cillis S, Granato S, Angusti T, Solitro F, Veltri A, Fiori C, Porpiglia F. Three-dimensional Virtual Models' Assistance During Minimally Invasive Partial Nephrectomy Minimizes the Impairment of Kidney Function. Eur Urol Oncol. 2022 Feb;5(1):104-108. doi: 10.1016/j.euo.2021.04.001. Epub 2021 Apr 24. PMID 33903083
- BACKGROUNDPorpiglia F, Fiori C, Checcucci E, Amparore D, Bertolo R. Hyperaccuracy Three-dimensional Reconstruction Is Able to Maximize the Efficacy of Selective Clamping During Robot-assisted Partial Nephrectomy for Complex Renal Masses. Eur Urol. 2018 Nov;74(5):651-660. doi: 10.1016/j.eururo.2017.12.027. Epub 2018 Jan 6. PMID 29317081
- BACKGROUNDGu L, Liu K, Du S, Li H, Ma X, Huang Q, Ai Q, Chen W, Gao Y, Fan Y, Xie Y, Yao Y, Wang H, Li P, Xuan Y, Wang B, Zhang X. Prediction of pentafecta achievement following laparoscopic partial nephrectomy: Implications for robot-assisted surgery candidates. Surg Oncol. 2020 Jun;33:32-37. doi: 10.1016/j.suronc.2020.01.004. Epub 2020 Jan 7. PMID 32561096