Renal Cell Carcinoma
Conditions
Keywords
zero ischemia, microwave, ablation, enucleation, renal cell carcinoma
Brief summary
The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.
Detailed description
Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with conventional laparoscopic partial nephrectomy.
Interventions
PROCEDURElaparoscopic microwave ablation-assisted enucleation
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 * exophytic cancer * distance from the hilar renal vessels and urinary collecting system \>= 1cm * patients with normal contralateral renal function (differential renal function of \>40% as determined by renal scintigraphy) * patients giving consent to the participation in the current clinical trial
Exclusion criteria
* patients with a history of other renal diseases, such as urinary lithiasis * patients with a history of renal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| absolute change in glomerular filtration rate (GFR) of the affected kidney | baseline, 3 months and 12 months | measured by renal scintigraphy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| absolute change in total GFR | baseline and 6 months | measured by renal scintigraphy |
| blood loss | during surgery | — |
| operation time | during surgery | — |
| absolute change in eGFR of the affected kidney | baseline, 3 months, 6 months and 12 months | — |
| postoperative complications | up to 6 months | number of participants with postoperative complications graded by Clavien- Dindo system |
| progression-free survival | 12 months | — |
| local recurrence | 12 months | — |
| surgical margin | 1 month | assessed according to the pathology report of the operation specimen |
Countries
China
Outcome results
None listed