Renal Cell Carcinoma
Conditions
Brief summary
To evaluate the feasibility and efficiency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.
Interventions
PROCEDUREzero ischemia robot-assisted laparoscopic RFA assisted TE
PROCEDUREzero ischemia robot-assisted laparoscopic partial nephrectomy
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with sporadic, unilateral, newly diagnosed T1a 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
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 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
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 |
|---|---|
| surgical margin | postoperative，up to 2 weeks after surgery |
| postoperative complications | postoperative，up to 30 days |
| progression-free survival | 12 months |
| estimated blood loss | during surgery |
| operative time | During surgery |
| Hospital stay time | The time from the surgery day to patient discharge, up to 2 weeks |
| changes in GFR of total kidneys by renal scintigraphyby of 6 month | baseline and 6 months |
| local recurrence | 12 months |
| changes in GFR of total kidneys by renal scintigraphyby | baseline and 12 months |
Countries
China
Contacts
Primary ContactJin Zhang, PhD.
Backup ContactYiran Huang, MD.
Outcome results
None listed