Assessment of Oncological and Functional Outcomes After Robot Assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy

Sponsor

Luzerner Kantonsspital (Other)

Overall Status

Completed

CT.gov ID

NCT02924922

Collaborator

Swiss Paraplegic Centre Nottwil (Other)

Enrollment

Location

Arms

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Neoplasms	Procedure: Laparoscopic partial nephrectomy Procedure: Robot assisted partial nephrectomy Device: Conventional laparoscopic instruments Device: Da- Vinci Robot and conventional laparoscopic instruments Drug: Mannitol	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Robot Assisted Partial Nephrectomy (RAPN) in Selective Ischemia Versus Laparoscopic Partial Nephrectomy (LPN) in Total Ischemia: Prospective Randomized Study to Assess Oncological and Functional Outcomes

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Laparoscopic partial nephrectomy Inclusion criteria fulfilled: Baseline Abdomen CT/MRI Patient Age, Weight, Height, Co-Medication Informed Consent Baseline renal function (eGFR, renal scintigraphy, sCreatinine, creatinine clearance) During hospitalization, one day before laparoscopic partial nephrectomy: eGFR sCreatinine Hemoglobin After surgery: Assessment of eGFR 4 days after operation Hb assessment every 6 H in the first 48 H Assessment of adverse events Histological Results 6, 12, 24 months after intervention: Creatinine Clearance (only performed at 6 months follow-up) Tc-99m MAG3Dynamic Scintigraphy (only performed at 6 months follow-up) eGFR Assessment of adverse events Assessment of possible recurrence Assesment of kidney volume variation	Procedure: Laparoscopic 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 Other Names: LPN Minimally invasive partial nephrectomy Device: Conventional laparoscopic instruments Endoscope, Scissor, Needleholder, Forceps, Suction unit, Ports, Tissel, CO2, Sutures, Needles, Scalpel, Ultrasound-Probe, Monitors Drug: Mannitol
Active Comparator: Robot assisted partial nephrectomy Inclusion criteria fulfilled: Baseline Abdomen CT/MRI Patient Age, Weight, Height, Co-Medication Informed Consent Baseline renal function (eGFR, renal scintigraphy, sCreatinine, creatinine clearance) During hospitalization, one day before robot assisted partial nephrectomy: eGFR sCreatinine Hemoglobin After surgery: Assessment of eGFR 4 days after operation Hb assessment every 6 H in the first 48 H Assessment of adverse events Histological Results 6, 12, 24 months after intervention: Creatinine Clearance (only performed at 6 months follow-up) Tc-99m MAG3Dynamic Scintigraphy (only performed at 6 months follow-up) eGFR Assessment of adverse events Assessment of possible recurrence Assesment of kidney volume variation	Procedure: Robot 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 Other Names: RAPN Da Vinci Robot assisted minimally invasive surgery Device: Da- Vinci Robot and conventional laparoscopic instruments Da Vinci Robot, Console, Ports and Instruments; Suction unit, Forceps, Tisseel, Ultrasound Probe, Monitors Drug: Mannitol

Arm

Intervention/Treatment

Active Comparator: Laparoscopic partial nephrectomy

Inclusion criteria fulfilled: Baseline Abdomen CT/MRI Patient Age, Weight, Height, Co-Medication Informed Consent Baseline renal function (eGFR, renal scintigraphy, sCreatinine, creatinine clearance) During hospitalization, one day before laparoscopic partial nephrectomy: eGFR sCreatinine Hemoglobin After surgery: Assessment of eGFR 4 days after operation Hb assessment every 6 H in the first 48 H Assessment of adverse events Histological Results 6, 12, 24 months after intervention: Creatinine Clearance (only performed at 6 months follow-up) Tc-99m MAG3Dynamic Scintigraphy (only performed at 6 months follow-up) eGFR Assessment of adverse events Assessment of possible recurrence Assesment of kidney volume variation

Procedure: Laparoscopic 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

Other Names:

LPN

Minimally invasive partial nephrectomy

Device: Conventional laparoscopic instruments

Endoscope, Scissor, Needleholder, Forceps, Suction unit, Ports, Tissel, CO2, Sutures, Needles, Scalpel, Ultrasound-Probe, Monitors

Drug: Mannitol

Active Comparator: Robot assisted partial nephrectomy

Inclusion criteria fulfilled: Baseline Abdomen CT/MRI Patient Age, Weight, Height, Co-Medication Informed Consent Baseline renal function (eGFR, renal scintigraphy, sCreatinine, creatinine clearance) During hospitalization, one day before robot assisted partial nephrectomy: eGFR sCreatinine Hemoglobin After surgery: Assessment of eGFR 4 days after operation Hb assessment every 6 H in the first 48 H Assessment of adverse events Histological Results 6, 12, 24 months after intervention: Creatinine Clearance (only performed at 6 months follow-up) Tc-99m MAG3Dynamic Scintigraphy (only performed at 6 months follow-up) eGFR Assessment of adverse events Assessment of possible recurrence Assesment of kidney volume variation

Procedure: Robot 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

Other Names:

RAPN

Da Vinci

Robot assisted minimally invasive surgery

Device: Da- Vinci Robot and conventional laparoscopic instruments

Da Vinci Robot, Console, Ports and Instruments; Suction unit, Forceps, Tisseel, Ultrasound Probe, Monitors

Drug: Mannitol

Outcome Measures

Primary Outcome Measures

Change of Scintigraphic Split Renal Function (%) after surgery [Scintigraphic split renal function (%) preoperatively and at 6 months follow up]

Secondary Outcome Measures

Duration of Operation [During surgery]
Duration of Warm Ischemia [During surgery]
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]

Other Outcome Measures

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)]
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]