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

NCT02511275 | Terminated DMC

• 2 other identifiers: 13081422014-A00098-39
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nephrectomy; Kidney Cancer; Microdialysis

Keywords

parenchymal clamping; microdialysis technique; partial nephrectomy

Outcome Measures

Primary Outcomes (1)

• Average interstitial lactate concentrations (peak lactate and lactate/pyruvate ratio)

  every 10 minutes unitl the end of clamping

Secondary Outcomes (3)

• Interstitial concentrations of lactate, pyruvate, lactate/pyruvate ratio, glycerol concentration (marker of impaired cellular membrane) and glucose concentration

  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

  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

Study Arms (1)

renal microdialysis

OTHER

patient with renal microdialysis

Procedure: Renal microdialysis

Interventions

Renal microdialysis PROCEDURE

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.

renal microdialysis

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• University Hospital of Saint-Etienne: collaborator

Study Sites (1)

Chu de Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Kidney Neoplasms

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

Study Officials

• Nicolas MOTTET, MD PhD

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: July 30, 2015
• Study Start: February 3, 2015
• Primary Completion: March 10, 2015
• Study Completion: March 30, 2015
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

FR (1)