Actively Recruiting
Zero Ischemia Robot-Assisted Microwave Ablation Assisted Suture-less Enucleation of Renal Cell Carcinoma With T1 Stage: A Randomized Clinical Trial
Led by RenJi Hospital · Updated on 2024-12-10
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new surgical technique called zero ischemia robot-assisted microwave ablation assisted suture-less tumor enucleation for patients with T1 stage renal cell carcinoma (RCC). This study builds on previous findings where the laparoscopic version of this technique showed better preservation of kidney function compared to conventional laparoscopic partial nephrectomy. The goal is to adapt this approach to robotic surgery, adding suture-less methods and using real-time contrast-enhanced ultrasonography to improve safety and precision. The study compares two groups of patients with T1 stage RCC: one group undergoes the zero ischemia robot-assisted microwave ablation and suture-less tumor enucleation, while the other group has traditional robotic-assisted partial nephrectomy. During the experimental procedure, a microwave ablation probe is inserted into the tumor under ultrasound guidance, with controlled ablation cycles to minimize bleeding. The tumor is then carefully separated from the kidney without clamping the renal artery, and suturing is done only if needed to repair the urinary collecting system. Participants will be followed for at least 12 months after surgery with various assessments including measurements of kidney function through glomerular filtration rate (GFR) and estimated GFR (eGFR), blood loss during surgery, surgical margins, postoperative complications, recurrence rates, and hospital stay duration. The study includes baseline, 3-month, and 12-month evaluations to monitor kidney function and other outcomes. This monitoring aims to understand the impact of the new surgical technique on kidney preservation and patient recovery.
CONDITIONS
Brief Title
Zero Ischemia Robot-Assisted MWA Assisted Suture-less Tumor Enucleation of RCC With T1 Stage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
- Patients scheduled for robot-assisted laparoscopic nephron sparing surgery
- Patients with normal contralateral renal function (differential renal function of >40% as determined by radionuclide scintigraphy)
- Patients agreeable to participate in this long-term follow-up study
You will not qualify if you...
- Patients older than 80 years
- Patients with other renal diseases (including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
- Patients not able to tolerate the robot-assisted laparoscopic procedure
- Patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
- Patients with the renal tumor involving urinary collecting system or distance from the tumor edge to the collecting system ≤ 4 mm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants undergo either Zero Ischemia Robot-Assisted Microwave Ablation assisted suture-less tumor enucleation or traditional robotic-assisted partial nephrectomy, followed by immediate post-operative care to monitor surgical outcomes and complications.
1 surgical visit and approximately 6 post-operative visits
Duration - 12 months
Participants are monitored for renal function, surgical margins, complications, and cancer progression or recurrence over the year following surgery.
Visits at baseline, 3 months, and 12 months
Trial Site Locations
Total: 1 location
1
Ethics Committee of Shanghai Renji Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Jiwei Huang, PhD.
Y
Yiran Huang, MD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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