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

Not Applicable

• Conditions: Renal Cancer

• Registration Number: NCT03679572
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-05
• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-20
• Primary Completion: 2020-02-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Number of group conversion in the zero ischemia method.	6 months	The feasibility of the new technique is assessed by counting the number of group conversion towards conventional technique.
Surgical duration in the two groups	6 months	Duration between the first incision and the skin closure
Complications	1 month	number of complications per and post-surgery up to 1 month
Hemoglobine rate variation	1 month	For patients having no received blood transfusion, the hemoglobine rate variation is assessed in percentage at one month in post-surgery.
Positive surgical margins	1 month	Number of positive surgical margins
Variation between global GFR in the two groups	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.
Renal parenchyma preserved	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.
Per-surgery blood loss	1 month	per-surgery blood loss in millimeter

Trial Locations

Locations (1)

University Hospital Grenoble-Alps (CHU-GA); 🇫🇷 La Tronche, France