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

Primary Purpose

Renal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Robot assisted partial nephrectomy super-selective clamping
Robot assisted partial nephrectomy with renal artery clamping
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cancer focused on measuring partial nephrectomy, robot-assisted, surgery, near-infrared fluorescence, ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Grenoble-Alps (CHU-GA)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot assisted partial nephrectomy super-selective clamping

Robot assisted partial nephrectomy with renal artery clamping

Arm Description

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.

The partial nephrectomy with robotic assistance is performed using a renal artery. It's the conventional method.

Outcomes

Primary Outcome Measures

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
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

Number of group conversion in the zero ischemia method.
The feasibility of the new technique is assessed by counting the number of group conversion towards conventional technique.
Surgical duration in the two groups
Duration between the first incision and the skin closure
Complications
number of complications per and post-surgery up to 1 month
Per-surgery blood loss
per-surgery blood loss in millimeter
Hemoglobine rate variation
For patients having no received blood transfusion, the hemoglobine rate variation is assessed in percentage at one month in post-surgery.
Positive surgical margins
Number of positive surgical margins
Variation between global GFR in the two groups
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
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.

Full Information

First Posted
March 26, 2018
Last Updated
March 17, 2020
Sponsor
University Hospital, Grenoble
Collaborators
Clinical Investigation Centre for Innovative Technology Network, Intuitive Surgical
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1. Study Identification

Unique Protocol Identification Number
NCT03679572
Brief Title
Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence
Acronym
EMERALD
Official Title
Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence: A Prospective, Monocentric, Randomized, Comparative and Open-label Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Clinical Investigation Centre for Innovative Technology Network, Intuitive Surgical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancer
Keywords
partial nephrectomy, robot-assisted, surgery, near-infrared fluorescence, ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot assisted partial nephrectomy super-selective clamping
Arm Type
Experimental
Arm Description
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.
Arm Title
Robot assisted partial nephrectomy with renal artery clamping
Arm Type
Active Comparator
Arm Description
The partial nephrectomy with robotic assistance is performed using a renal artery. It's the conventional method.
Intervention Type
Procedure
Intervention Name(s)
Robot assisted partial nephrectomy super-selective clamping
Other Intervention Name(s)
Robot assisted zero-ischemia partial nephrectomy with the Da Vinci robot (device)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Robot assisted partial nephrectomy with renal artery clamping
Other Intervention Name(s)
Robot assisted partial nephrectomy with conventional method
Intervention Description
Partial nephrectomy is performed with the conventional method in wich a renal artery clamping is done.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of group conversion in the zero ischemia method.
Description
The feasibility of the new technique is assessed by counting the number of group conversion towards conventional technique.
Time Frame
6 months
Title
Surgical duration in the two groups
Description
Duration between the first incision and the skin closure
Time Frame
6 months
Title
Complications
Description
number of complications per and post-surgery up to 1 month
Time Frame
1 month
Title
Per-surgery blood loss
Description
per-surgery blood loss in millimeter
Time Frame
1 month
Title
Hemoglobine rate variation
Description
For patients having no received blood transfusion, the hemoglobine rate variation is assessed in percentage at one month in post-surgery.
Time Frame
1 month
Title
Positive surgical margins
Description
Number of positive surgical margins
Time Frame
1 month
Title
Variation between global GFR in the two groups
Description
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.
Time Frame
6 months
Title
Renal parenchyma preserved
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Alexandre Long, MD, PhD
Organizational Affiliation
department of urology and renal transplantation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble-Alps (CHU-GA)
City
La Tronche
ZIP/Postal Code
38700
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33931361
Citation
Long JA, Fiard G, Giai J, Teyssier Y, Fontanell A, Overs C, Poncet D, Descotes JL, Rambeaud JJ, Moreau-Gaudry A, Ittobane T, Bouzit A, Bosson JL, Lanchon C. Superselective Ischemia in Robotic Partial Nephrectomy Does Not Provide Better Long-term Renal Function than Renal Artery Clamping in a Randomized Controlled Trial (EMERALD): Should We Take the Risk? Eur Urol Focus. 2022 May;8(3):769-776. doi: 10.1016/j.euf.2021.04.009. Epub 2021 Apr 27.
Results Reference
derived

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Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence

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