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| Name | Class |
|---|---|
| Clinical Investigation Centre for Innovative Technology Network | NETWORK |
| Intuitive Surgical | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot assisted partial nephrectomy super-selective clamping | Experimental | 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. |
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| Robot assisted partial nephrectomy with renal artery clamping | Active Comparator | The partial nephrectomy with robotic assistance is performed using a renal artery. It's the conventional method. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot assisted partial nephrectomy super-selective clamping | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Alexandre Long, MD, PhD | department of urology and renal transplantation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble-Alps (CHU-GA) | La Tronche | 38700 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33931361 | Derived | Long JA, Fiard G, Giai J, Teyssier Y, Fontanell A, Overs C, Poncet D, Descotes JL, Rambeaud JJ, Moreau-Gaudry A, Ittobane T, Bouzit A, Bosson JL, Lanchon C. Superselective Ischemia in Robotic Partial Nephrectomy Does Not Provide Better Long-term Renal Function than Renal Artery Clamping in a Randomized Controlled Trial (EMERALD): Should We Take the Risk? Eur Urol Focus. 2022 May;8(3):769-776. doi: 10.1016/j.euf.2021.04.009. Epub 2021 Apr 27. |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Robot assisted partial nephrectomy with renal artery clamping | Procedure | Partial nephrectomy is performed with the conventional method in wich a renal artery clamping is done. |
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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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |