Clinical trial NCT03679572: Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence
Official title: Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence: A Prospective, Monocentric, Randomized, Comparative and Open-label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Cancer
Keywords: partial nephrectomy
robot-assisted
surgery
near-infrared fluorescence
ischemia
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
name: Intuitive Surgical
First posted: 2018-09-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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
timeFrame: 6 months
Secondary outcomes:
measure: Number of group conversion in the zero ischemia method.
timeFrame: 6 months
measure: Surgical duration in the two groups
timeFrame: 6 months
measure: Complications
timeFrame: 1 month
measure: Per-surgery blood loss
timeFrame: 1 month
measure: Hemoglobine rate variation
timeFrame: 1 month
measure: Positive surgical margins
timeFrame: 1 month
measure: Variation between global GFR in the two groups
timeFrame: 6 months
measure: Renal parenchyma preserved
timeFrame: 6 months
Other outcomes:
Locations:
city: La Tronche
country: France
facility: University Hospital Grenoble-Alps (CHU-GA)
Study officials:
affiliation: department of urology and renal transplantation
name: Jean-Alexandre Long, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.