NephrectomyNECPARNCT02511275
Nephrotoxicity Associated to Parenchymal Clamping During Partial Nephrectomy Using a Microdialysis Technique
A study testing Renal microdialysis in people with Nephrectomy and Kidney Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrectomy, Kidney Cancer, Microdialysis
- What is being tested?
- Renal microdialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2015to 30 Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Nephrectomy, Kidney Cancer, Microdialysis
- Being tested
- Renal microdialysis
- Keywords
- parenchymal clamping, microdialysis technique, partial nephrectomy
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal microdialysisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| renal microdialysis | Other | patient with renal microdialysis Receives: Procedure: Renal microdialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average interstitial lactate concentrations (peak lactate and lactate/pyruvate ratio)
Measured: 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
composite measure
Measured: 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
Measured: 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
Measured: inclusion day and at 2 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study start3 Feb 2015
- Primary completion10 Mar 2015
- Study completion30 Mar 2015
Why it stopped: this type of surgery is now performed with a surgical robot that no longer allows the realization of microdialysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Saint-Etienne
- Responsible party
- Sponsor
- Investigators
- Nicolas MOTTET, MD PhD, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511275
- Sponsor's protocol ID
- 1308142
- Other IDs
- 2014-A00098-39
- Acronym
- NECPAR
- Status last verified
- May 2018
- First submitted
- 20 Feb 2015
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nephrotoxicity Associated to Parenchymal Clamping During Partial Nephrectomy Using a Microdialysis Technique: NECPAR Study
- ClinicalTrials.gov ID
- NCT02511275
- Acronym / sponsor ID
- NECPAR / 1308142
- Conditions
- Nephrectomy, Kidney Cancer, Microdialysis
- Keywords
- parenchymal clamping, microdialysis technique, partial nephrectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: this type of surgery is now performed with a surgical robot that no longer allows the realization of microdialysis
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- University Hospital of Saint-Etienne
- Study start
- 3 Feb 2015 (actual)
- Primary completion
- 10 Mar 2015 (actual)
- Study completion
- 30 Mar 2015 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| renal microdialysis | Other | Procedure: Renal microdialysispatient with renal microdialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal microdialysisRenal 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. | Procedure or surgery | renal microdialysis |
Primary outcome
Average interstitial lactate concentrations (peak lactate and lactate/pyruvate ratio)
Time frame: every 10 minutes unitl the end of clamping
3 secondary outcomes
Interstitial concentrations of lactate, pyruvate, lactate/pyruvate ratio, glycerol concentration (marker of impaired cellular membrane) and glucose concentration
Time frame: 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
Time frame: 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
Time frame: inclusion day and at 2 months postoperatively
Results and safety
The study was stopped early (reason given: this type of surgery is now performed with a surgical robot that no longer allows the realization of microdialysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas MOTTET, MD PhD principal investigator
CHU de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal microdialysis in people with Nephrectomy and Kidney Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: this type of surgery is now performed with a surgical robot that no longer allows the realization of microdialysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average interstitial lactate concentrations (peak lactate and lactate/pyruvate ratio) (time frame: every 10 minutes unitl the end of clamping). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018; AzTrials last refreshed its copy on 28 Oct 2026.