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

NCT02924922 | Completed DMC

• 1 other identifier: EKNZ 2015-446
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Neoplasms

Keywords

renal cell carcinoma; laparoscopic partial nephrectomy; robot-assisted partial nephrectomy; nephron sparing surgery; warm ischemia time; renal function loss

Outcome Measures

Primary Outcomes (1)

• Change of Scintigraphic Split Renal Function (%) after surgery

  Scintigraphic split renal function (%) preoperatively and at 6 months follow up

Secondary Outcomes (7)

• Duration of Operation

  During surgery

• Duration of Warm Ischemia

  During surgery

• Mass Resection Time

  During surgery

• Suturing Time

  During surgery

• Amount of Spared Renal Parenchyma

  During surgery

Other Outcomes (4)

• Change of Renal Function After Surgery (eGFR)

  eGFR assessment preoperatively, first postoperative day and at all follow ups (6, 12, 24 months)

• Change of Renal Function After Surgery (sCreatinin)

  Serum creatinine preoperatively, first postoperative day and at all follow ups (6, 12, 24 months)

• Change of Renal Function After Surgery (24 hour Creatinin Clearance)

  24 hour Creatinin Clearance preoperatively and at 6 months follow up

Study Arms (2)

Laparoscopic partial nephrectomy

ACTIVE COMPARATOR

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

Procedure: Laparoscopic partial nephrectomy; Device: Conventional laparoscopic instruments; Drug: Mannitol

Robot assisted partial nephrectomy

ACTIVE COMPARATOR

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

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

Interventions

Laparoscopic partial nephrectomy 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

Also known as: LPN, Minimally invasive partial nephrectomy

Laparoscopic partial nephrectomy

Robot assisted partial nephrectomy 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

Also known as: RAPN, Da Vinci, Robot assisted minimally invasive surgery

Robot assisted partial nephrectomy

Conventional laparoscopic instruments DEVICE

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

Laparoscopic partial nephrectomy

Da- Vinci Robot and conventional laparoscopic instruments DEVICE

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

Robot assisted partial nephrectomy

Mannitol DRUG

Laparoscopic partial nephrectomy; Robot assisted partial nephrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead
• Swiss Paraplegic Research, Nottwil: collaborator

Study Sites (1)

Klinik für Urologie, Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Agostino Mattei, Ass. Prof.

  Luzerner Kantonsspital Luzern, Leiter der Klinik für Urologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. Dr. med.

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: October 5, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

CH (1)