Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial.
Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial. This project is based on the previous research and aims to develop an approach of the combination of intraoperative real time contrast-enhanced ultrasonography technology, sutureless technology and the zero ischemia robot-Assisted tumor enucleation of the kidney. By using the real time contrast-enhanced ultrasonography technology, the current shortcomings of the zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation were overcome. The degree of elimination was monitored during surgery to avoid excessive bleeding caused by insufficient ablation during the surgery. Beside, the difficulty of zero ischemia laparoscopic radio frequency ablation is reduced, and doctors can quickly grasp the learning curve of this technology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Under the visualization of ultrasound contrast imaging through the operative channel, a microwave ablation probe was inserted into the tumor (at the interface between the tumor and kidney, close to the tumor base). The microwave ablation device was used, with a power setting of 70 W for initiating microwave ablation. Depending on the tumor volume and depth, 1-3 ablation cycles were performed, with each cycle lasting 1-3 minutes. After reaching the pseudocapsule of the tumor, a combination of blunt dissection, sharp cutting, and blunt dissection was employed to separate the tumor from the renal parenchyma . The renal artery was not occluded during the procedure.If intraoperative injury to the collecting system is suspected, the collecting system should be sutured normally, while simultaneously suturing the outer layer of renal parenchyma to prevent urine leakage.
robotic-assisted laparoscopic partial nephrectomy
Ethics Committee of Shanghai Renji Hospital
Shanghai, China
RECRUITINGThe absolute change in glomerular filtration rate (GFR) of the affected kidney
12 months minus baseline
Time frame: baseline and 12 months
The changes of estimated GFR (eGFR)
12 months minus baseline
Time frame: baseline and 12 months
estimated blood loss
Time frame: during surgery
changes in GFR of total kidneys by renal scintigraphyby
Time frame: baseline and 12 months
surgical margin
Time frame: postoperative up to 2 weeks after surgery
postoperative complications
Time frame: postoperative up to 30 days
progression-free survival
Time frame: 12 months
local recurrence
Time frame: 12 months
operative time
Time frame: During surgery
Hospital stay time
Time frame: The time from the surgery day to patient discharge, up to 2 weeks
changes in GFR of total kidneys by renal scintigraphyby of 3 month
Time frame: baseline and 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.