Kidney Neoplasms
Conditions
Keywords
Nephron sparing surgery, Zero ischemia, Warm ischemia, Laparoscopic, Radiofrequency ablation, Microwave ablation
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 T1 RCC patients in randomized clinical trial in multiple centers.
Interventions
renal artery will be clamped during surgery.
PROCEDUREzero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital
Changhai Hospital
Shanghai 6th People's Hospital
Fudan University
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
* patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma * patients scheduled for laparoscopic nephron sparing surgery * patients agreeable to participate in this long-term follow-up study
Exclusion criteria
* patients' aged \>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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in glomerular filtration rate (GFR) of the affected kidney | Baseline and 30 months |
| changes of estimated GFR (eGFR) | Baseline and 30 months |
Secondary
| Measure | Time frame |
|---|---|
| postoperative complications | postoperative，up to 30 days |
| the rate of local recurrence | through study completion, an average of 3 years |
| estimated blood loss | during surgery |
| Hospital stay time | The time from the surgery day to patient discharge, up to 2 weeks |
| progression-free survival rate | through study completion, an average of 3 years |
| operative time | During surgery |
| rates of positive surgical margin | postoperative，up to 2 weeks after surgery |
Countries
China
Contacts
Primary Contactjiwei huang, M.D.
Outcome results
None listed