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

Not Applicable

Completed

• Conditions: Kidney Neoplasms
• Interventions: Procedure: Laparoscopic partial nephrectomy; Procedure: Robot assisted partial nephrectomy; Device: Conventional laparoscopic instruments; Device: Da- Vinci Robot and conventional laparoscopic instruments; Drug: Mannitol

• Registration Number: NCT02924922
• Lead Sponsor: Luzerner Kantonsspital

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-09-23
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Primary Completion: 2018-12
• Study Completion: 2019-04-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic partial nephrectomy	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
Laparoscopic partial nephrectomy	Conventional laparoscopic instruments	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
Robot assisted partial nephrectomy	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
Robot assisted partial nephrectomy	Da- Vinci Robot and conventional laparoscopic instruments	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
Laparoscopic partial nephrectomy	Mannitol	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
Robot assisted partial nephrectomy	Mannitol	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

Primary Outcome Measures

Name	Time	Method
Change of Scintigraphic Split Renal Function (%) after surgery	Scintigraphic split renal function (%) preoperatively and at 6 months follow up

Secondary Outcome Measures

Name	Time	Method
Suturing Time	During surgery
Amount of Spared Renal Parenchyma	During surgery
Duration of Operation	During surgery
Duration of Warm Ischemia	During surgery
Mass Resection Time	During surgery
Rate of Recurrence	6 months - 12 months - 24 months
Positive Surgical Margin Rate	During surgery

Trial Locations

Locations (1)

Klinik für Urologie, Kantonsspital Luzern; 🇨🇭 Luzern, Switzerland