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Trial record 26 of 6564 for:    zero

Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence (EMERALD)

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ClinicalTrials.gov Identifier: NCT03679572
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : September 20, 2018
Sponsor:
Collaborators:
Clinical Investigation Centre for Innovative Technology Network
Intuitive Surgical
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE March 26, 2018
First Posted Date  ICMJE September 20, 2018
Last Update Posted Date September 20, 2018
Actual Study Start Date  ICMJE February 5, 2018
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2018)
Benefit on postoperative renal function of fluorescence-enhanced super-selective clamping during robot assisted partial nephrectomy compared with robot-assisted partial nephrectomy with renal artery clamping [ Time Frame: 6 months ]
The glomerular filtration rate (GFR) of the kidney operated is assessed at 6 months after surgery. This value is compared to that assessed before the surgery to see the variation. This variation is compare between the two groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2018)
  • Number of group conversion in the zero ischemia method. [ Time Frame: 6 months ]
    The feasibility of the new technique is assessed by counting the number of group conversion towards conventional technique.
  • Surgical duration in the two groups [ Time Frame: 6 months ]
    Duration between the first incision and the skin closure
  • Complications [ Time Frame: 1 month ]
    number of complications per and post-surgery up to 1 month
  • Per-surgery blood loss [ Time Frame: 1 month ]
    per-surgery blood loss in millimeter
  • Hemoglobine rate variation [ Time Frame: 1 month ]
    For patients having no received blood transfusion, the hemoglobine rate variation is assessed in percentage at one month in post-surgery.
  • Positive surgical margins [ Time Frame: 1 month ]
    Number of positive surgical margins
  • Variation between global GFR in the two groups [ Time Frame: 6 months ]
    The variation of the global GFR is assessed after surgery, when patient is discharged. This value is compared to the that collected before the surgery.
  • Renal parenchyma preserved [ Time Frame: 6 months ]
    The percentage of renal parenchyma preserved is evaluated by CT renal volumetry at 6 months after the surgery. The value is compared to that collected before the surgery.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence
Official Title  ICMJE Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence: A Prospective, Monocentric, Randomized, Comparative and Open-label Study
Brief Summary Patients with renal cancer are commonly treated by robot-assisted partial nephrectomy. Renal artery clamping is commonly required inducing kidney ischemia during surgery. It impacts parenchymal and renal function. This study aims to compare a new surgical procedure in order to reduce ischemia effect and preserve renal function after partial nephrectomy for renal tumour.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cancer
Intervention  ICMJE
  • Procedure: Robot assisted partial nephrectomy super-selective clamping
    The device used to performe the surgery is a Da Vinci robot. After injection of infracyanine, the super-selective clamping is possible. The surgery is performed using a specific clamping of the tumor arteries. Super-selective ischemia is checked using near infrared fluorescence.
    Other Name: Robot assisted zero-ischemia partial nephrectomy with the Da Vinci robot (device)
  • Procedure: Robot assisted partial nephrectomy with renal artery clamping
    Partial nephrectomy is performed with the conventional method in wich a renal artery clamping is done.
    Other Name: Robot assisted partial nephrectomy with conventional method
Study Arms  ICMJE
  • Experimental: Robot assisted partial nephrectomy super-selective clamping
    The Da Vinci robot (device) allows to use near-infrared fluorescence in order to clamp precisely the branches of the vascularization for the partial nephrectomy. The healthy parenchyma ischemia is avoided.
    Intervention: Procedure: Robot assisted partial nephrectomy super-selective clamping
  • Active Comparator: Robot assisted partial nephrectomy with renal artery clamping
    The partial nephrectomy with robotic assistance is performed using a renal artery. It's the conventional method.
    Intervention: Procedure: Robot assisted partial nephrectomy with renal artery clamping
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • candidate for a robot-assisted partial nephrectomy for renal tumour
  • patient affiliated to social security
  • signature of the informed consent

Exclusion Criteria:

  • proven or suspected allergy to the indocyanine green
  • coagulation disorder contraindicating robot assistance in the partial nephrectomy
  • medical pathology contraindicating pneumo-peritoneum
  • multiple tumors
  • horseshoe kidney
  • exclusion period of another interventionnal study
  • protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean-Alexandre Long, MD, PhD +33 476767642 jalong@chu-grenoble.fr
Contact: Emilie Chipon, PhD +33 476767313 echipon@chu-grenoble.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03679572
Other Study ID Numbers  ICMJE 38RC17.142
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE
  • Clinical Investigation Centre for Innovative Technology Network
  • Intuitive Surgical
Investigators  ICMJE
Principal Investigator: Jean-Alexandre Long, MD, PhD department of urology and renal transplantation
PRS Account University Hospital, Grenoble
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP