Renal Cell Carcinoma, Zero Ischemia
Conditions
Keywords
renal cell carcinoma, ischemia, radio frequency ablation
Brief summary
To evaluate the feasibility and efficiency of zero ischemia laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.
Detailed description
Warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (PN). Zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. The technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. Our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.
Interventions
PROCEDUREzero ischemia laparoscopic RFA assisted TE
PROCEDUREischemia
conventional laparoscopic partial nephrectomy
Sponsors
National Natural Science Foundation of China
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
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 T1a presumed renal cell carcinoma * 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 * 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 close to the calyces
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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in GFR of total kidneys by renal scintigraphyby of 6 month | 6 month | — |
| estimated GFR (eGFR) | 12 months | — |
| changes in GFR of total kidneys by renal scintigraphyby | baseline and 12 months | — |
| blood loss | during surgery | — |
| estimated GFR (eGFR) of 6 month | 6 month | — |
| postoperative complications | 12 months | — |
| progression-free survival | 12 months | — |
| local recurrence | 12 months | — |
| the absolute change in glomerular filtration rate (GFR) of the affected kidney | baseline and 6 months | 6 months minus baseline |
| surgical margin | postoperative | pathologic confirm of surgical margin |
Countries
China
Contacts
Primary ContactYiran Huang, M.D.
Outcome results
None listed