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Kidney NeoplasmsNCT02924922

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

A study testing Laparoscopic partial nephrectomy, Robot assisted partial nephrectomy and Conventional laparoscopic instruments in people with Kidney Neoplasms, run by Luzerner Kantonsspital at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Neoplasms
What is being tested?
Laparoscopic partial nephrectomy, Robot assisted partial nephrectomy and Conventional laparoscopic instruments
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteSwitzerland
Study dates
May 2016to 1 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Klinik für Urologie, Kantonsspital Luzern

    Lucerne, 6000

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Laparoscopic partial nephrectomy, Robot assisted partial nephrectomy, Conventional laparoscopic instruments, Da- Vinci Robot and conventional laparoscopic instruments, Mannitol
Keywords
renal cell carcinoma, laparoscopic partial nephrectomy, robot-assisted partial nephrectomy, nephron sparing surgery, warm ischemia time, renal function loss
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic partial nephrectomyProcedure or surgery

    Also called LPN, Minimally invasive 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

  • Robot assisted partial nephrectomyProcedure or surgery

    Also called RAPN, Da Vinci, Robot assisted minimally invasive surgery

    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

  • Conventional laparoscopic instrumentsDevice

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

  • Da- Vinci Robot and conventional laparoscopic instrumentsDevice

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

  • MannitolDrug

Study groups in NCT02924922
Study groupRoleWhat they receive
Laparoscopic partial nephrectomyActive comparator1. 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
Receives: Procedure: Laparoscopic partial nephrectomy; Device: Conventional laparoscopic instruments; Drug: Mannitol
Robot assisted partial nephrectomyActive comparator1. 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
Receives: Procedure: Robot assisted partial nephrectomy; Device: Da- Vinci Robot and conventional laparoscopic instruments; Drug: Mannitol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Scintigraphic Split Renal Function (%) after surgery

    Measured: Scintigraphic split renal function (%) preoperatively and at 6 months follow up

Secondary outcomes (7)

  1. Duration of Operation

    Measured: During surgery

  2. Duration of Warm Ischemia

    Measured: During surgery

  3. Mass Resection Time

    Measured: During surgery

  4. Suturing Time

    Measured: During surgery

  5. Amount of Spared Renal Parenchyma

    Measured: During surgery

  6. Rate of Recurrence

    Measured: 6 months - 12 months - 24 months

  7. Positive Surgical Margin Rate

    Measured: During surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionDec 2018
  4. Study completion1 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02924922
Sponsor's protocol ID
EKNZ 2015-446
Status last verified
Aug 2020
First submitted
23 Sep 2016
Last updated
1 Sep 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic partial nephrectomy, Robot assisted partial nephrectomy and Conventional laparoscopic instruments in people with Kidney Neoplasms, run by Luzerner Kantonsspital at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Scintigraphic Split Renal Function (%) after surgery (time frame: Scintigraphic split renal function (%) preoperatively and at 6 months follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02924922.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.

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