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

Kidney Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02924922
• Other study ID #: EKNZ 2015-446
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 1, 2019

Study information

• Verified date: August 2020
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 1, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Neoplasms

Intervention

Procedure:
• 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
• 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

Device:
• Conventional laparoscopic instruments
Endoscope, Scissor, Needleholder, Forceps, Suction unit, Ports, Tissel, CO2, Sutures, Needles, Scalpel, Ultrasound-Probe, Monitors
• Da- Vinci Robot and conventional laparoscopic instruments
Da Vinci Robot, Console, Ports and Instruments; Suction unit, Forceps, Tisseel, Ultrasound Probe, Monitors

Drug:
• Mannitol

Locations

Country	Name	City	State
Switzerland	Klinik für Urologie, Kantonsspital Luzern	Luzern

Sponsors (2)

Lead Sponsor	Collaborator
Luzerner Kantonsspital	Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Renal Function After Surgery (eGFR)		eGFR assessment preoperatively, first postoperative day and at all follow ups (6, 12, 24 months)
Other	Change of Renal Function After Surgery (sCreatinin)		Serum creatinine preoperatively, first postoperative day and at all follow ups (6, 12, 24 months)
Other	Change of Renal Function After Surgery (24 hour Creatinin Clearance)		24 hour Creatinin Clearance preoperatively and at 6 months follow up
Other	Change of Hemoglobin after Surgery (Hb)		Preoperatively, 6 hours postoperatively, 12 hours postoperatively, 18 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
Primary	Change of Scintigraphic Split Renal Function (%) after surgery		Scintigraphic split renal function (%) preoperatively and at 6 months follow up
Secondary	Duration of Operation		During surgery
Secondary	Duration of Warm Ischemia		During surgery
Secondary	Mass Resection Time		During surgery
Secondary	Suturing Time		During surgery
Secondary	Amount of Spared Renal Parenchyma		During surgery
Secondary	Rate of Recurrence		6 months - 12 months - 24 months
Secondary	Positive Surgical Margin Rate		During surgery