Kidney Neoplasms
Conditions
Keywords
renal cell carcinoma, laparoscopic partial nephrectomy, robot-assisted partial nephrectomy, nephron sparing surgery, warm ischemia time, renal function loss
Brief summary
Currently, partial nephrectomy (PN) is considered as the gold standard treatment modality for small renal masses. In this setting, robot-assisted and conventional laparoscopic approaches are gaining more consensus every day. However, until now, no superiority of one technique over the other has yet been demonstrated, especially on postoperative function recovery. This study compares oncological and functional outcomes after laparoscopic partial nephrectomy versus robot assisted partial nephrectomy.
Detailed description
Renal cell carcinoma (RCC) represents 2-3% of all cancers, with the highest incidence in Western countries. Due to increased detection of tumors by ultrasound (US) and computed tomography (CT), the number of incidentally diagnosed RCCs has increased. These tumors are usually smaller and of lower stage. Currently, partial nephrectomy (PN) is considered as the gold standard treatment modality for small renal masses. In this setting, robot-assisted and conventional laparoscopic approaches are gaining more consensus every day. However, until now, no superiority of one technique over the other has yet been demonstrated, especially on postoperative function recovery. This is a single center prospective randomized trial investigating the functional and oncological outcomes of minimally invasive (laparoscopic and robot-assisted) nephron sparing surgery. Patients will be assessed with renal scintigraphy and 24 hours creatinine clearance pre- and postoperatively. Furthermore, duration of the operation, resection and suturing times will be assessed. Renal function recovery is defined as primary endpoint; oncological outcome and positive surgical margin rate are defined as secondary measures. In addition, kidney volume variation will be calculated to describe the amount of healthy tissue preserved in both procedures.The aim of the study is to assess whether robot assisted partial nephrectomy in selective ischemia is superior to laparoscopic partial nephrectomy in global ischemia in terms of functional and oncological outcomes.
Interventions
DEVICEConventional laparoscopic instruments
Endoscope, Scissor, Needleholder, Forceps, Suction unit, Ports, Tissel, CO2, Sutures, Needles, Scalpel, Ultrasound-Probe, Monitors
DEVICEDa- Vinci Robot and conventional laparoscopic instruments
Da Vinci Robot, Console, Ports and Instruments; Suction unit, Forceps, Tisseel, Ultrasound Probe, Monitors
DRUGMannitol
PROCEDURELaparoscopic partial nephrectomy
The renal hilus is identified and both vein and artery are dissected. A laparoscopic ultrasound probe is introduced through a 12 mm port to define the tumor resection margins. A laparoscopic Satinsky clamp is used to induce total kidney ischemia, clamping both vein and artery. Athermal resection of the tumor is performed and titanium clips are used to close interlobar or arcuate arteries encountered during resection. The defect is closed with stitches secured by Hem-o-Lok clips and haemostatic glue. Ischemia is interrupted once renorrhaphy is completed
PROCEDURERobot assisted partial nephrectomy
The renal hilus is carefully dissected, so that the arterial segmental branches are reached. Tumor resection margins are identified through ultrasound. Drop-in bulldog clamps are used to clamp segmental arterial branches and induce selective ischemia. Indocyanine green 0.2-0.3mg/KG is infused intravenously a few seconds after the selective ischemia is induced. The Firefly near infra-red fluorescence system is used to determine the extent of the ischemic area. The ischemic zone can now be tailored to the tumor by adding or removing bulldog clamps according to the vascular anatomical conditions. Athermal resection of the tumor is performed and titanium clips are used to close interlobar or arcuate arteries encountered during resection. The resection defect is closed with stitches secured by Hem-o-Lok clips and haemostatic glue. Selective ischemia will be interrupted once renorrhaphy is completed
Sponsors
Swiss Paraplegic Research, Nottwil
Luzerner Kantonsspital
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
* Men and women \>18 years * Organ-confined renal cancer (tumor stage cT1-cT2), assessed by MRI/CT * Patient qualifies for robotic or laparoscopic partial nephrectomy * Written informed consent
Exclusion criteria
* Renal masses necessitating radical tumor nephrectomy * Patients with single kidney * Bilateral kidney cancer when simultaneously operated * Previous partial nephrectomy * Renal insufficiency: Chronic Kidney Disease (CKD) stages 4-5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Scintigraphic Split Renal Function (%) after surgery | Scintigraphic split renal function (%) preoperatively and at 6 months follow up |
Secondary
| Measure | Time frame |
|---|---|
| Mass Resection Time | During surgery |
| Suturing Time | During surgery |
| Amount of Spared Renal Parenchyma | During surgery |
| Rate of Recurrence | 6 months - 12 months - 24 months |
| Positive Surgical Margin Rate | During surgery |
| Duration of Operation | During surgery |
| Duration of Warm Ischemia | During surgery |
Other
| Measure | Time frame |
|---|---|
| Change of Renal Function After Surgery (24 hour Creatinin Clearance) | 24 hour Creatinin Clearance preoperatively and at 6 months follow up |
| Change of Hemoglobin after Surgery (Hb) | Preoperatively, 6 hours postoperatively, 12 hours postoperatively, 18 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively |
| Change of Renal Function After Surgery (eGFR) | eGFR assessment preoperatively, first postoperative day and at all follow ups (6, 12, 24 months) |
| Change of Renal Function After Surgery (sCreatinin) | Serum creatinine preoperatively, first postoperative day and at all follow ups (6, 12, 24 months) |
Countries
Switzerland
Outcome results
None listed