Kidney Neoplasms
Conditions
Keywords
Microwave ablation, Nephronsparing surgery, Zero ischemia, suture less
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREZero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation
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.
PROCEDURErobotic-assisted laparoscopic partial nephrectomy
robotic-assisted laparoscopic partial nephrectomy
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma 2. patients scheduled for robot-assisted laparoscopic nephron sparing surgery 3. patients with normal contralateral renal function (differential renal function of \>40% as determined by radionuclide scintigraphy) 4. patients agreeable to participate in this long-term follow-up study
Exclusion criteria
1. patients' age \>80 years 2. patients with other renal diseases (including kidney stone, glomerular nephritis, etc.)which might affect the renal function of the operative kidney 3. patients not able to tolerate the robot-assisted laparoscopic procedure 4. patients with previous renal surgery or history of any inflammatory conditions of the operative kidney 5. patients with the renal tumor involving urinary collecting system or distance from the tumor edge to the collecting system ≤ 4 mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The absolute change in glomerular filtration rate (GFR) of the affected kidney | baseline and 12 months | 12 months minus baseline |
| The changes of estimated GFR (eGFR) | baseline and 12 months | 12 months minus baseline |
Secondary
| Measure | Time frame |
|---|---|
| changes in GFR of total kidneys by renal scintigraphyby of 3 month | baseline and 3 months |
| local recurrence | 12 months |
| estimated blood loss | during surgery |
| operative time | During surgery |
| surgical margin | postoperative up to 2 weeks after surgery |
| postoperative complications | postoperative up to 30 days |
| progression-free survival | 12 months |
| changes in GFR of total kidneys by renal scintigraphyby | baseline and 12 months |
| Hospital stay time | The time from the surgery day to patient discharge, up to 2 weeks |
Countries
China
Contacts
Primary ContactJiwei Huang, PhD.
Backup ContactYiran Huang, MD.
Outcome results
None listed