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

March 17, 2020 updated by: University Hospital, Grenoble

Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence: A Prospective, Monocentric, Randomized, Comparative and Open-label Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • University Hospital Grenoble-Alps (CHU-GA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Robot assisted partial nephrectomy with conventional method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
Surgical duration in the two groups
Time Frame: 6 months
Duration between the first incision and the skin closure
6 months
Complications
Time Frame: 1 month
number of complications per and post-surgery up to 1 month
1 month
Per-surgery blood loss
Time Frame: 1 month
per-surgery blood loss in millimeter
1 month
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.
1 month
Positive surgical margins
Time Frame: 1 month
Number of positive surgical margins
1 month
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Intuitive Surgical
Clinical Investigation Centre for Innovative Technology Network

Investigators

  • Principal Investigator: Jean-Alexandre Long, MD, PhD, department of urology and renal transplantation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 5, 2018

Primary Completion (ACTUAL)

February 10, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

September 19, 2018

First Posted (ACTUAL)

September 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.142

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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