Renal CancerEMERALDNCT03679572
Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence
A study testing Robot assisted partial nephrectomy super-selective clamping and Robot assisted partial nephrectomy with renal artery clamping in people with Renal Cancer, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer
- What is being tested?
- Robot assisted partial nephrectomy super-selective clamping and Robot assisted partial nephrectomy with renal artery clamping
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- candidate for a robot-assisted partial nephrectomy for renal tumour
- patient affiliated to social security
- signature of the informed consent
Who cannot join
- 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
- protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Renal Cancer
- Being tested
- Robot assisted partial nephrectomy super-selective clamping, Robot assisted partial nephrectomy with renal artery clamping
- Keywords
- partial nephrectomy, robot-assisted, surgery, near-infrared fluorescence, ischemia
- Medical subject headings
- Kidney Neoplasms, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted partial nephrectomy super-selective clampingProcedure or surgery
Also called Robot assisted zero-ischemia partial nephrectomy with the Da Vinci robot (device)
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.
Robot assisted partial nephrectomy with renal artery clampingProcedure or surgery
Also called Robot assisted partial nephrectomy with conventional method
Partial nephrectomy is performed with the conventional method in wich a renal artery clamping is done.
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted partial nephrectomy super-selective clamping | Experimental | 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. Receives: Procedure: Robot assisted partial nephrectomy super-selective clamping |
| Robot assisted partial nephrectomy with renal artery clamping | Active comparator | The partial nephrectomy with robotic assistance is performed using a renal artery. It's the conventional method. Receives: Procedure: Robot assisted partial nephrectomy with renal artery clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (8)
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.
Measured: 6 months
Surgical duration in the two groups
Duration between the first incision and the skin closure
Measured: 6 months
Complications
number of complications per and post-surgery up to 1 month
Measured: 1 month
Per-surgery blood loss
per-surgery blood loss in millimeter
Measured: 1 month
Hemoglobine rate variation
For patients having no received blood transfusion, the hemoglobine rate variation is assessed in percentage at one month in post-surgery.
Measured: 1 month
Positive surgical margins
Number of positive surgical margins
Measured: 1 month
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start5 Feb 2018
- Primary completion10 Feb 2020
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, Intuitive Surgical
- Responsible party
- Sponsor
- Investigators
- Jean-Alexandre Long, MD, PhD, Principal investigator, department of urology and renal transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679572
- Sponsor's protocol ID
- 38RC17.142
- Acronym
- EMERALD
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33931361
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence: A Prospective, Monocentric, Randomized, Comparative and Open-label Study
- ClinicalTrials.gov ID
- NCT03679572
- Acronym / sponsor ID
- EMERALD / 38RC17.142
- Conditions
- Renal Cancer
- Keywords
- partial nephrectomy, robot-assisted, surgery, near-infrared fluorescence, ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, Intuitive Surgical
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot assisted partial nephrectomy super-selective clamping | Experimental | Procedure: Robot assisted partial nephrectomy super-selective clampingThe 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. |
| Robot assisted partial nephrectomy with renal artery clamping | Active comparator | Procedure: Robot assisted partial nephrectomy with renal artery clampingThe partial nephrectomy with robotic assistance is performed using a renal artery. It's the conventional method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- candidate for a robot-assisted partial nephrectomy for renal tumour
- patient affiliated to social security
- signature of the informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot assisted partial nephrectomy super-selective clampingAlso: Robot assisted zero-ischemia partial nephrectomy with the Da Vinci robot (device)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. | Procedure or surgery | Robot assisted partial nephrectomy super-selective clamping |
| Robot assisted partial nephrectomy with renal artery clampingAlso: Robot assisted partial nephrectomy with conventional methodPartial nephrectomy is performed with the conventional method in wich a renal artery clamping is done. | Procedure or surgery | Robot assisted partial nephrectomy with renal artery clamping |
Primary outcome
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.
8 secondary outcomes
Number of group conversion in the zero ischemia method.
Time frame: 6 months
Surgical duration in the two groups
Time frame: 6 months
Complications
Time frame: 1 month
Per-surgery blood loss
Time frame: 1 month
Hemoglobine rate variation
Time frame: 1 month
Positive surgical margins
Time frame: 1 month
Variation between global GFR in the two groups
Time frame: 6 months
Renal parenchyma preserved
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 33931361Long 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Alexandre Long, MD, PhD principal investigator
department of urology and renal transplantation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot assisted partial nephrectomy super-selective clamping and Robot assisted partial nephrectomy with renal artery clamping in people with Renal Cancer, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03679572, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.