Laser Speckle Contrast Imaging, Surgical Eye & ICG Fluorescence Imaging for Perfusion Assessment of the Gastric Conduit

Summary

Rationale Globally, esophageal cancer is the seventh most common cancer type, with over half a million cases reported in 2020. The survival of gastroesophageal cancer is poor and the prognosis is primarily determined by the possibilities for curative treatment. After resection of part of the esophagus and cardia, the reconstruction of the esophagus is performed with a gastric conduit where an anastomosis is made with the proximal esophageal stump. Globally, a Minimally invasive Esophagectomy (MIE) has a high morbidity rate and a mortality rate ranging up to 5% as a result of the procedure. One of the most feared complications is an anastomotic leakage (AL) with a rate of around 12.5% and a mortality rate of around 15%. AL is associated with prolonged hospital stay and increased re-operation rates. It is generally accepted that impaired blood flow of the gastric conduit is the most important cause of AL. The surgical procedure of an esophagectomy and reconstruction inherently compromises the blood supply of the gastric conduit. However other than the surgical eye, there is no gold standard in assessing this. Surgeons generally look for traditional indicators of tissue viability such as pulsating vessels, bleeding of the resected edges, tissue color and intestinal motility. However, an objective indication of the tissue perfusion is still lacking, implying the clinical need for one.

Objectives In this trial the investigators will study the utility of PerfusiX-Imaging for perfusion assessment of the gastric conduit in comparison with the standard of care.

Study design The current study is a prospective, observational single-center study in the Medical Center Leeuwarden.

Study population A total of 30 patients undergoing an esophageal resection will be included. Patient related study procedures All patients will undergo the standard-of-care program which includes perfusion assessment by the surgical eye and ICG-fluorescence imaging. In addition to this standard-of-care, 2D-perfusion maps will be generated from images taken with PerfusiX-Imaging (LIMIS Development BV, Leeuwarden, The Netherlands) in combination with a standard surgical laparoscope. Not related to the patient, the PerfusiX-Imaging images will be shown to the surgeon postoperatively and peroperative questionnaires will be filled regarding the standard-of-care perfusion assessment.

Study parameters/endpoints Due to the explorative character of this study, there is no formal hierarchy in the respective endpoints of this study. In this, all endpoints will add to the overall assessment of the feasibility of the PerfusiX-imaging derived visual feedback. The investigators will look at the percentage of operating surgeons that indicated no change in location of the anastomosis or operating plan based on the additional PerfusiX-Imaging. The percentage of the non-involved surgeons that indicated no change in location of the anastomosis or operating plan based on the additional PerfusiX-Imaging. And the homogeneity of the change in location between non-involved surgeons for individual patients will be analyzed in order to get a sense for the subjectivity of the interpretation of the images.

The investigators will also compare the additional PerfusiX-Imaging derived visual feedback to the standard of care by looking at the homogeneity in location of the watershed area between PerfusiX-Imaging, ICG-fluorescence and based on visual assessment by the surgical eye. The difference in the location of watershed area between PerfusiX-Imaging and ICG-fluorescence or based on visual assessment.

In order to get a sense of the scale of the indicated change in location of the anastomosis the investigators will look at the estimated change in location of the anastomosis of the gastric conduit/ the esophageal stump in centimeters by the operating surgeon. The estimated change in location of the anastomosis of the gastric conduit/ the esophageal stump in centimeters by non-involved surgeons. Lastly, the investigators will compare the change in the location of the anastomosis by non-involved surgeons in comparison to the operating surgeon; Burden, risk and benefit to participation Burden Not applicable. Risks Not applicable. Benefit Not applicable.

Conditions

• Oesophageal Cancer

Interventions

DEVICE

Laser Speckle Contrast Imaging using the PerfusiX-Imaging device

Patient will undergo the standard-of-care gastric conduit procedure and in addition, peroperative Laser Speckle Contrast Imaging of the gastric conduit and eosophagus will be performed.

Sponsors & Collaborators

• University of Groningen

  collaborator OTHER

• LIMIS Development

  collaborator UNKNOWN

• Frisius Medisch Centrum

  lead OTHER

Principal Investigators

• E.C. Boerma, MD/PhD · Frisius Medisch Centrum

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-26

Primary Completion

2023-12-31

Completion

2024-05-31

Countries

• Netherlands

Study Locations