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

NCT ID: NCT02924922

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-04-01

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.

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.

Conditions

Kidney Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Laparoscopic partial nephrectomy

Intervention Type: 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

Conventional laparoscopic instruments

Intervention Type: DEVICE

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

Mannitol

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Robot assisted partial nephrectomy

Intervention Type: 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

Da- Vinci Robot and conventional laparoscopic instruments

Intervention Type: DEVICE

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

Mannitol

Intervention Type: DRUG

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Conventional laparoscopic instruments

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

Intervention Type: DEVICE

Da- Vinci Robot and conventional laparoscopic instruments

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

Intervention Type: DEVICE

Mannitol

Intervention Type: DRUG

Other Intervention Names

LPN; Minimally invasive partial nephrectomy; RAPN; Da Vinci; Robot assisted minimally invasive surgery

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role: collaborator

Luzerner Kantonsspital

OTHER

Sponsor Role: lead

Responsible Party

Agostino Mattei

Ass. Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Agostino Mattei, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital Luzern, Leiter der Klinik für Urologie

Locations

Klinik für Urologie, Kantonsspital Luzern

Lucerne, , Switzerland

Countries

Switzerland

Other Identifiers

EKNZ 2015-446

Identifier Type: -

Identifier Source: org_study_id