Clinical trial NCT02924922: Assessment of Oncological and Functional Outcomes After Robot Assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Neoplasms
Keywords: renal cell carcinoma
laparoscopic partial nephrectomy
robot-assisted partial nephrectomy
nephron sparing surgery
warm ischemia time
renal function loss
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
Collaborators: name: Swiss Paraplegic Research, Nottwil
First posted: 2016-10-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of Scintigraphic Split Renal Function (%) after surgery
timeFrame: Scintigraphic split renal function (%) preoperatively and at 6 months follow up
Secondary outcomes:
measure: Duration of Operation
timeFrame: During surgery
measure: Duration of Warm Ischemia
timeFrame: During surgery
measure: Mass Resection Time
timeFrame: During surgery
measure: Suturing Time
timeFrame: During surgery
measure: Amount of Spared Renal Parenchyma
timeFrame: During surgery
measure: Rate of Recurrence
timeFrame: 6 months - 12 months - 24 months
measure: Positive Surgical Margin Rate
timeFrame: During surgery
Other outcomes:
measure: Change of Renal Function After Surgery (eGFR)
timeFrame: eGFR assessment preoperatively, first postoperative day and at all follow ups (6, 12, 24 months)
measure: Change of Renal Function After Surgery (sCreatinin)
timeFrame: Serum creatinine preoperatively, first postoperative day and at all follow ups (6, 12, 24 months)
measure: Change of Renal Function After Surgery (24 hour Creatinin Clearance)
timeFrame: 24 hour Creatinin Clearance preoperatively and at 6 months follow up
measure: Change of Hemoglobin after Surgery (Hb)
timeFrame: Preoperatively, 6 hours postoperatively, 12 hours postoperatively, 18 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
Locations:
city: Luzern
country: Switzerland
facility: Klinik für Urologie, Kantonsspital Luzern
Study officials:
affiliation: Luzerner Kantonsspital Luzern, Leiter der Klinik für Urologie
name: Agostino Mattei, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References: