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Trial record 25 of 5971 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

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.

Condition or disease Intervention/treatment Phase
Renal Cancer Procedure: Robot assisted partial nephrectomy super-selective clamping Procedure: Robot assisted partial nephrectomy with renal artery clamping Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence: A Prospective, Monocentric, Randomized, Comparative and Open-label Study
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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)

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Surgical duration in the two groups [ Time Frame: 6 months ]
    Duration between the first incision and the skin closure

  3. Complications [ Time Frame: 1 month ]
    number of complications per and post-surgery up to 1 month

  4. Per-surgery blood loss [ Time Frame: 1 month ]
    per-surgery blood loss in millimeter

  5. 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.

  6. Positive surgical margins [ Time Frame: 1 month ]
    Number of positive surgical margins

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679572


Contacts
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Contact: Jean-Alexandre Long, MD, PhD +33 476767642 jalong@chu-grenoble.fr
Contact: Emilie Chipon, PhD +33 476767313 echipon@chu-grenoble.fr

Locations
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France
University Hospital Grenoble-Alps (CHU-GA) Recruiting
La Tronche, France, 38700
Contact: Jean-Alexandre Long, MD,PhD       jalong@chu-grenoble.fr   
Contact: Emilie Chipon, PhD       echipon@chu-grenoble.fr   
Sub-Investigator: Cécilia Lanchon, MD         
Sub-Investigator: Gaelle Fiard, MD,PhD         
Sub-Investigator: Jean-Luc Descotes, MD,PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Clinical Investigation Centre for Innovative Technology Network
Intuitive Surgical
Investigators
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Principal Investigator: Jean-Alexandre Long, MD, PhD department of urology and renal transplantation

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03679572     History of Changes
Other Study ID Numbers: 38RC17.142
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:
partial nephrectomy
robot-assisted
surgery
near-infrared fluorescence
ischemia

Additional relevant MeSH terms:
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Ischemia
Kidney Neoplasms
Carcinoma, Renal Cell
Pathologic Processes
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type