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Spots Global Cancer Trial Database for Nephrotoxicity Associated to Parenchymal Clamping During Partial Nephrectomy Using a Microdialysis Technique

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Trial Identification

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

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

Study ID: NCT02511275

Interventions

Renal microdialysis

Study Description

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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Chu de Saint Etienne, Saint Etienne, , France

Contact Details

Name: Nicolas MOTTET, MD PhD

Affiliation: CHU de Saint Etienne

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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