About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Preoperative three-dimensional reconstruction
Diagnostic testOn 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.
Treatment groups
Trial outcomes
Primary outcomes
warm ischemia time
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.
Secondary outcomes
operative time
Intraoperative bleeding
Length of postoperative hospital stay
Incidence of postoperative complications
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tianjin Medical University Cancer Institute and Hospital
Lead sponsor
Sir Run Run Shaw Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Peking University First Hospital
Collaborator
Liaoning Cancer Hospital & Institute
Collaborator
The Second Affiliated Hospital of Dalian Medical University
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Qilu Hospital of Shandong University
Collaborator
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Collaborator
Hebei Medical University Fourth Hospital
Collaborator
West China Hospital
Collaborator
Tongji Hospital
Collaborator
Sun Yat-sen University Tumor Hospital
Collaborator
Shanghai Cancer Hospital, China
Collaborator
Shengjing Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: