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NCT Number: NCT02924922

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

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.

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Key information

Conditions

Kidney Neoplasms Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Urologie, Kantonsspital Luzern

Lucerne, 6000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic partial nephrectomy

Procedure

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

Robot assisted partial nephrectomy

Procedure

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

Conventional laparoscopic instruments

Device

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

Da- Vinci Robot and conventional laparoscopic instruments

Device

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

Mannitol

Drug

Primary outcomes

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

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

Secondary outcomes

  1. Duration of Operation

    Time frame: During surgery

  2. Duration of Warm Ischemia

    Time frame: During surgery

  3. Mass Resection Time

    Time frame: During surgery

  4. Suturing Time

    Time frame: During surgery

  5. Amount of Spared Renal Parenchyma

    Time frame: During surgery

  6. Rate of Recurrence

    Time frame: 6 months - 12 months - 24 months

  7. Positive Surgical Margin Rate

    Time frame: During surgery

Other outcomes

  1. Change of Renal Function After Surgery (eGFR)

    Time frame: eGFR assessment preoperatively, first postoperative day and at all follow ups (6, 12, 24 months)

  2. Change of Renal Function After Surgery (sCreatinin)

    Time frame: Serum creatinine preoperatively, first postoperative day and at all follow ups (6, 12, 24 months)

  3. Change of Renal Function After Surgery (24 hour Creatinin Clearance)

    Time frame: 24 hour Creatinin Clearance preoperatively and at 6 months follow up

  4. Change of Hemoglobin after Surgery (Hb)

    Time frame: Preoperatively, 6 hours postoperatively, 12 hours postoperatively, 18 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Collaborators

  • Swiss Paraplegic Research, Nottwil

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Oct 5, 2016
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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