- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02924922
Assessment of Oncological and Functional Outcomes After Robot Assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy
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
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Luzern, Switzerland, 6000
- Klinik für Urologie, Kantonsspital Luzern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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:
Endoscope, Scissor, Needleholder, Forceps, Suction unit, Ports, Tissel, CO2, Sutures, Needles, Scalpel, Ultrasound-Probe, Monitors
|
Active Comparator: 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:
Da Vinci Robot, Console, Ports and Instruments; Suction unit, Forceps, Tisseel, Ultrasound Probe, Monitors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of Scintigraphic Split Renal Function (%) after surgery
Time Frame: Scintigraphic split renal function (%) preoperatively and at 6 months follow up
|
Scintigraphic split renal function (%) preoperatively and at 6 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of Operation
Time Frame: During surgery
|
During surgery
|
Duration of Warm Ischemia
Time Frame: During surgery
|
During surgery
|
Mass Resection Time
Time Frame: During surgery
|
During surgery
|
Suturing Time
Time Frame: During surgery
|
During surgery
|
Amount of Spared Renal Parenchyma
Time Frame: During surgery
|
During surgery
|
Rate of Recurrence
Time Frame: 6 months - 12 months - 24 months
|
6 months - 12 months - 24 months
|
Positive Surgical Margin Rate
Time Frame: During surgery
|
During surgery
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of Renal Function After Surgery (eGFR)
Time Frame: eGFR assessment preoperatively, first postoperative day and at all follow ups (6, 12, 24 months)
|
eGFR assessment preoperatively, first postoperative day and at all follow ups (6, 12, 24 months)
|
Change of Renal Function After Surgery (sCreatinin)
Time Frame: Serum creatinine preoperatively, first postoperative day and at all follow ups (6, 12, 24 months)
|
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)
Time Frame: 24 hour Creatinin Clearance preoperatively and at 6 months follow up
|
24 hour Creatinin Clearance preoperatively and at 6 months follow up
|
Change of Hemoglobin after Surgery (Hb)
Time Frame: Preoperatively, 6 hours postoperatively, 12 hours postoperatively, 18 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
|
Preoperatively, 6 hours postoperatively, 12 hours postoperatively, 18 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Agostino Mattei, Ass. Prof., Luzerner Kantonsspital Luzern, Leiter der Klinik für Urologie
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKNZ 2015-446
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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