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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|Contact: Jean-Alexandre Long, MD, PhD||+33 email@example.com|
|Contact: Emilie Chipon, PhD||+33 firstname.lastname@example.org|
|University Hospital Grenoble-Alps (CHU-GA)||Recruiting|
|La Tronche, France, 38700|
|Contact: Jean-Alexandre Long, MD,PhD email@example.com|
|Contact: Emilie Chipon, PhD firstname.lastname@example.org|
|Sub-Investigator: Cécilia Lanchon, MD|
|Sub-Investigator: Gaelle Fiard, MD,PhD|
|Sub-Investigator: Jean-Luc Descotes, MD,PhD|
|Principal Investigator:||Jean-Alexandre Long, MD, PhD||department of urology and renal transplantation|