Renal Cancer
Conditions
Keywords
partial nephrectomy, robot-assisted, surgery, near-infrared fluorescence, ischemia
Brief summary
Patients with renal cancer are commonly treated by robot-assisted partial nephrectomy. Renal artery clamping is commonly required inducing kidney ischemia during surgery. It impacts parenchymal and renal function. This study aims to compare a new surgical procedure in order to reduce ischemia effect and preserve renal function after partial nephrectomy for renal tumour.
Interventions
PROCEDURERobot assisted partial nephrectomy super-selective clamping
The device used to performe the surgery is a Da Vinci robot. After injection of infracyanine, the super-selective clamping is possible. The surgery is performed using a specific clamping of the tumor arteries. Super-selective ischemia is checked using near infrared fluorescence.
PROCEDURERobot assisted partial nephrectomy with renal artery clamping
Partial nephrectomy is performed with the conventional method in wich a renal artery clamping is done.
Sponsors
Clinical Investigation Centre for Innovative Technology Network
Intuitive Surgical
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* candidate for a robot-assisted partial nephrectomy for renal tumour * patient affiliated to social security * signature of the informed consent
Exclusion criteria
* proven or suspected allergy to the indocyanine green * coagulation disorder contraindicating robot assistance in the partial nephrectomy * medical pathology contraindicating pneumo-peritoneum * multiple tumors * horseshoe kidney * exclusion period of another interventionnal study * protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Benefit on postoperative renal function of fluorescence-enhanced super-selective clamping during robot assisted partial nephrectomy compared with robot-assisted partial nephrectomy with renal artery clamping | 6 months | The glomerular filtration rate (GFR) of the kidney operated is assessed at 6 months after surgery. This value is compared to that assessed before the surgery to see the variation. This variation is compare between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical duration in the two groups | 6 months | Duration between the first incision and the skin closure |
| Complications | 1 month | number of complications per and post-surgery up to 1 month |
| Per-surgery blood loss | 1 month | per-surgery blood loss in millimeter |
| Number of group conversion in the zero ischemia method. | 6 months | The feasibility of the new technique is assessed by counting the number of group conversion towards conventional technique. |
| Positive surgical margins | 1 month | Number of positive surgical margins |
| Variation between global GFR in the two groups | 6 months | The variation of the global GFR is assessed after surgery, when patient is discharged. This value is compared to the that collected before the surgery. |
| Renal parenchyma preserved | 6 months | The percentage of renal parenchyma preserved is evaluated by CT renal volumetry at 6 months after the surgery. The value is compared to that collected before the surgery. |
| Hemoglobine rate variation | 1 month | For patients having no received blood transfusion, the hemoglobine rate variation is assessed in percentage at one month in post-surgery. |
Countries
France
Outcome results
None listed