NCT03679572

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 26, 2018

Last Update Submit

March 17, 2020

Conditions

Renal Cancer

Keywords

partial nephrectomyrobot-assistedsurgerynear-infrared fluorescenceischemia

Outcome Measures

Primary Outcomes (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

    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 Outcomes (8)

  • Number of group conversion in the zero ischemia method.

    6 months

  • Surgical duration in the two groups

    6 months

  • Complications

    1 month

  • Per-surgery blood loss

    1 month

  • Hemoglobine rate variation

    1 month

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Procedure: Robot assisted partial nephrectomy with renal artery clamping

Interventions

Robot assisted partial nephrectomy super-selective clampingPROCEDURE

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.

Also known as: Robot assisted zero-ischemia partial nephrectomy with the Da Vinci robot (device)
Robot assisted partial nephrectomy super-selective clamping
Robot assisted partial nephrectomy with renal artery clampingPROCEDURE

Partial nephrectomy is performed with the conventional method in wich a renal artery clamping is done.

Also known as: Robot assisted partial nephrectomy with conventional method
Robot assisted partial nephrectomy with renal artery clamping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • candidate for a robot-assisted partial nephrectomy for renal tumour
  • patient affiliated to social security
  • signature of the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble-Alps (CHU-GA)

La Tronche, 38700, France

Location

Related Publications (1)

  • 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.

    PMID: 33931361DERIVED

MeSH Terms

Conditions

Kidney NeoplasmsIschemia

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Alexandre Long, MD, PhD

    department of urology and renal transplantation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

September 20, 2018

Study Start

February 5, 2018

Primary Completion

February 10, 2020

Study Completion

December 1, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

FR(1)