Nephrotoxicity Associated to Parenchymal Clamping During... | NCT02511275

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

NCT02511275

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Last Update Posted

May 8, 2018Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Nephrectomy
Kidney Cancer
Microdialysis

Interventions

Renal microdialysis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014-A00098-39	Other Identifier	ANSM

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

this type of surgery is now performed with a surgical robot that no longer allows the realization of microdialysis

Expanded Access Info

Start Date

Feb 3, 2015Actual

Primary Completion Date

Mar 10, 2015Actual

Completion Date

Mar 30, 2015Actual

First Submitted Date

Feb 20, 2015

First Submission Date that Met QC Criteria

Jul 27, 2015

First Posted Date

Jul 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2018

Last Update Posted Date

May 8, 2018Actual

Name	Class
University Hospital of Saint-Etienne	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
renal microdialysis	Other	patient with renal microdialysis	Procedure: Renal microdialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolas MOTTET, MD PhD	CHU de Saint Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu de Saint Etienne		Saint-Etienne		42055	France

Condition Browse Module

MeSH Terms

ID	Term
D007680	Kidney Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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