Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence

Study Overview
=================
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.

Official Title
-----------------
Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence: A Prospective, Monocentric, Randomized, Comparative and Open-label Study

Conditions
-----------------
Renal Cancer

Intervention / Treatment
-----------------
* Procedure: Robot assisted partial nephrectomy super-selective clamping
* Procedure: Robot assisted partial nephrectomy with renal artery clamping


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot assisted partial nephrectomy super-selective clamping<br>The Da Vinci robot (device) allows to use near-infrared fluorescence in order to clamp precisely the branches of the vascularization for the partial nephrectomy. The healthy parenchyma ischemia is avoided. | Procedure: Robot assisted partial nephrectomy super-selective clamping<br>* 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.<br>* Other names: Robot assisted zero-ischemia partial nephrectomy with the Da Vinci robot (device);|
| Active Comparator: Robot assisted partial nephrectomy with renal artery clamping<br>The partial nephrectomy with robotic assistance is performed using a renal artery. It's the conventional method. | Procedure: Robot assisted partial nephrectomy with renal artery clamping<br>* Partial nephrectomy is performed with the conventional method in wich a renal artery clamping is done.<br>* Other names: Robot assisted partial nephrectomy with conventional method;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of group conversion in the zero ischemia method. | The feasibility of the new technique is assessed by counting the number of group conversion towards conventional technique. | 6 months | 
| Surgical duration in the two groups | Duration between the first incision and the skin closure | 6 months | 
| Complications | number of complications per and post-surgery up to 1 month | 1 month | 
| Per-surgery blood loss | per-surgery blood loss in millimeter | 1 month | 
| Hemoglobine rate variation | For patients having no received blood transfusion, the hemoglobine rate variation is assessed in percentage at one month in post-surgery. | 1 month | 
| Positive surgical margins | Number of positive surgical margins | 1 month | 
| Variation between global GFR in the two groups | 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. | 6 months | 
| Renal parenchyma preserved | 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. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
partial nephrectomy, robot-assisted, surgery, near-infrared fluorescence, ischemia