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

August 31, 2020 updated by: Agostino Mattei, Luzerner Kantonsspital

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

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 Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Luzern, Switzerland, 6000
        • Klinik für Urologie, Kantonsspital Luzern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
  1. Inclusion criteria fulfilled:

    • Baseline Abdomen CT/MRI
    • Patient Age, Weight, Height, Co-Medication
    • Informed Consent
    • Baseline renal function (eGFR, renal scintigraphy, sCreatinine, creatinine clearance)
  2. During hospitalization, one day before laparoscopic partial nephrectomy:

    • eGFR
    • sCreatinine
    • Hemoglobin
  3. 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
  4. 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
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
Endoscope, Scissor, Needleholder, Forceps, Suction unit, Ports, Tissel, CO2, Sutures, Needles, Scalpel, Ultrasound-Probe, Monitors
Active Comparator: Robot assisted partial nephrectomy
  1. Inclusion criteria fulfilled:

    • Baseline Abdomen CT/MRI
    • Patient Age, Weight, Height, Co-Medication
    • Informed Consent
    • Baseline renal function (eGFR, renal scintigraphy, sCreatinine, creatinine clearance)
  2. During hospitalization, one day before robot assisted partial nephrectomy:

    • eGFR
    • sCreatinine
    • Hemoglobin
  3. 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
  4. 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
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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Agostino Mattei, Ass. Prof., Luzerner Kantonsspital Luzern, Leiter der Klinik für Urologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

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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