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

Summary

After the esophagectomy, the stomach is most commonly used to restore continuity of the upper gastro-intestinal tract. The esophagogastric anastomosis is prone to serious complications such as anastomotic leakage (AL) The reported incidence of AL after esophagectomy ranges from 5%-20%. The AL associated mortality ranges from 18-40% compared with an overall in-hospital mortality of 4-6%. The main cause of AL is tissue hypoxia, which results from impaired perfusion of the pedicle stomach graft. Clinical judgment is unreliable in determining anastomotic perfusion. Therefore, an objective, validated, and reproducible method to evaluate tissue perfusion at the anastomotic site is urgently needed. Indocyanine green angiography (ICGA) is a near infrared fluorescent (NIRF) perfusion imaging using indocyanine green (ICG). ICGA is a safe, easy and reproducible method for graft perfusion analysis, but it is not yet calibrated. The purpose of this study is to evaluate the feasibility of quantification of ICGA to assess graft perfusion and its influence on AL in patients after minimally invasive Ivor Lewis esophagectomy (MIE) for cancer.

Conditions

• Anastomotic Leak
• Esophageal 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

Sponsors & Collaborators

• Kom Op Tegen Kanker

  collaborator OTHER

• University Hospital, Ghent

  lead OTHER

Principal Investigators

• Yves [email protected], MD, PhD · University Hospital, Ghent

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-13

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Belgium

Study Locations