Nephrotoxicity Associated to Parenchymal Clamping During Partial Nephrectomy Using a Microdialysis Technique (NECPAR)

Assessment of Nephrotoxicity Associated to Parenchymal Clamping During Partial Nephrectomy Using a Microdialysis Technique: NECPAR Study

Surgery plays a central role in kidney cancer management being the only therapy that offers the possibility of healing the patients. Currently, the partial nephrectomy is a standard technique because it meets the principle of nephron sparing surgery. A partial nephrectomy requires a control of the renal blood flow using a clamp, which can be parenchymal or vascular (pedicular). In France, most of the centers use pedicular clamping. It is well established that this technique results in warm ischemia of the entire healthy parenchyma and can lead to permanent kidney damages. Currently, no study evaluated the impact of parenchymal clamping on the healthy parenchyma.

The aim of the investigators study is to evaluate the nephrotoxicity of the healthy parenchyma due to parenchymal clamping during partial nephrectomy. This assessment will be done through a microdialysis technique. The microdialysis probe is directly implanted in the healthy unclamped parenchyma and will allow us to measure in real time, during the surgery, the biological changes related to anaerobic metabolism of renal interstitial space. All those measures will be completed by urinary and plasmatic assessments. Oxidative stress will be assessed using four markers of tubular viability : Interleukin 18 (IL18), Kidney Injury Molecule-1 (KIM-1), Neutrophil Gelatinase-Associated Lipocalin (NGAL) and cystatin C and four parameters of anaerobic metabolism : lactate, pyruvate, glycerol and glucose.

This is a prospective pilot study limited to 10 patients included over 12 months. Depending on the results, it will be further developed by a second study comparing parenchymal with pedicle clamping.

Study Overview

• Status: Terminated
• Conditions: Kidney Cancer; Nephrectomy; Microdialysis
• Intervention / Treatment: Procedure: Renal microdialysis

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42055
    • CHU de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients referred to the urological surgery department with an indication of partial nephrectomy
• Patients with a renal lesion classified T1 (≤7cm) or for T2 eligible to a partial nephrectomy and having an possibility to benefit from a parenchymal clamping (decided on preoperative imaging)

Exclusion Criteria:

• Patient with a chronic kidney disease (functional or structural renal abnormality evolving for more than three months and Glomerular Filtration Rate <60 ml/min)
• Patient carrying a renal lesion classified T1 but too close to the renal pedicle or not accessible for a parenchymal clamping
• Patients in whom tumor removal requires ice cooling or kidney pedicular clamping

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: renal microdialysis; patient with renal microdialysis	Procedure: Renal microdialysis; Renal microdialysis is an innovative and promising technique in the monitoring of renal ischemia. Its sterile nature enables intraoperative use to give us real-time reflection of the in situ metabolism. In Patients who participated in clinical research with this microinvasive technique, no complications including bleeding has been reported.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average interstitial lactate concentrations (peak lactate and lactate/pyruvate ratio)	every 10 minutes unitl the end of clamping

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interstitial concentrations of lactate, pyruvate, lactate/pyruvate ratio, glycerol concentration (marker of impaired cellular membrane) and glucose concentration	composite measure	every 10 minutes until the end of clamping then every 300 minutes until the third hour of no-clamping
Blood and urine concentration of Interleukin 18 (IL18), le Kidney Injury Molecule-1 (KIM-1), le Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Cystatin C	composite measure	1 hour before clamping, then Hour +2, Hour +6, Hour +12, Hour +24, Hour +36 ; Hour 0 corresponding to the timing of clamping
Preoperative creatinine		inclusion day and at 2 months postoperatively

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: University Hospital of Saint-Etienne
• Investigators: Principal Investigator: Nicolas MOTTET, MD PhD, CHU de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2015
• Primary Completion (Actual): March 10, 2015
• Study Completion (Actual): March 30, 2015

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: July 27, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Actual): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: partial nephrectomy; parenchymal clamping; microdialysis technique
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms
• Other Study ID Numbers: 1308142; 2014-A00098-39 (Other Identifier: ANSM)