Assessment of Graft Perfusion and Oxygenation for Improved Outcome in Esophageal Cancer Surgery

NARecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 13, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Anastomotic LeakEsophageal Cancer
Interventions
DIAGNOSTIC_TEST

Indocyanine green angiography

ICGA will be performed twice during standard esophagectomy: 30 minutes after the stomach graft creation and immediately before the esophagogastric anastomosis. stock dose of 25 mg ICG (Pulsion Medical Systems, Germany) will be diluted to 5 mg/mL with sterile water. An IV bolus of 0.5 mg/kg of ICG will be injected via a central venous catheter. Video data will be obtained with a charge-coupled device (CCD) camera fitted with a light-emitting diode emitting at a wavelength of 760mm (Visera® elite II, Olympus medical system corp, Tokyo, Japan). Images will be recorded starting immediately prior to injection until 3 minutes afterwards.

DIAGNOSTIC_TEST

Hemodynamic evaluation

Advanced continuous hemodynamic monitoring during surgery will be performed using a PiCCO® (Pulse index Continuous Cardiac Output, Pulsion Medical Systems, Germany) catheter.

DIAGNOSTIC_TEST

Biological and pathological markers of ischemia

"* Systemic and local capillary lactate on blood samples~* Mitochondrial Respiratory activity analyses on biopsies at 3 region of interest (ROI)~* Pathological analyses of the biopsies at 3 ROI"

Trial Locations (1)

9000

RECRUITING

University Hospital, Ghent

All Listed Sponsors
collaborator

Kom Op Tegen Kanker

OTHER

lead

University Hospital, Ghent

OTHER