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

Renal Cancer Clinical Trial

— EMERALD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03679572
• Other study ID #: 38RC17.142
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: December 1, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Kidney Neoplasms
• Renal Cancer

Intervention

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

Locations

Country	Name	City	State
France	University Hospital Grenoble-Alps (CHU-GA)	La Tronche

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology Network, Intuitive Surgical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months
Secondary	Surgical duration in the two groups	Duration between the first incision and the skin closure	6 months
Secondary	Complications	number of complications per and post-surgery up to 1 month	1 month
Secondary	Per-surgery blood loss	per-surgery blood loss in millimeter	1 month
Secondary	Hemoglobine rate variation	For patients having no received blood transfusion, the hemoglobine rate variation is assessed in percentage at one month in post-surgery.	1 month
Secondary	Positive surgical margins	Number of positive surgical margins	1 month
Secondary	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.	6 months
Secondary	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.	6 months