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

Luzerner Kantonsspital

Status: Completed

Conditions: Kidney Neoplasms

Treatments: Device: Conventional laparoscopic instruments; Procedure: Robot assisted partial nephrectomy; Drug: Mannitol; Procedure: Laparoscopic partial nephrectomy; Device: Da- Vinci Robot and conventional laparoscopic instruments

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02924922

EKNZ 2015-446

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Laparoscopic partial nephrectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic partial nephrectomy

Device: Conventional laparoscopic instruments

Drug: Mannitol

Robot assisted partial nephrectomy

Active Comparator group

Description:

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

Treatment:

Device: Da- Vinci Robot and conventional laparoscopic instruments

Drug: Mannitol

Procedure: Robot assisted partial nephrectomy